LARRY I. GILDERMAN, D.O.

OFFICE/MAILING ADDRESS:
Larry I. Gilderman, D.O.
Medical Director
University Clinical Research Inc.
1150 North University Drive
Pembroke Pines, Florida 33024

TELEPHONE/FAX NUMBER:
(954) 437-2024 (954) 432-6255

MEDICAL SPECIALTY:
Family Practice/Internal Medicine

UNDERGRADUATE EDUCATION:
Temple University

Philadelphia, Pennsylvania
B.S. – 1966

MEDICAL EDUCATION:
Philadelphia College of

Osteopathic Medicine
Philadelphia, Pennsylvania
D.O. – 1972

INTERNSHIP:
J.F. Kennedy Memorial Hospital
Straford, New Jersey
Rotating Internship -1972– 1973

HONOR FRATERNITY:
Lambda Omicron Gamma

LICENSURE:
Florida - 1973 (#OS-0003370)
New York – 1973
California – 1990
Pennsylvania – 1990

BOARD CERTIFICATION:
Diplomate, American Board of
Family Practice – 1978
Re-certified – 1996
Diplomate, American Board of
Quality Assurance and
Utilization Review – 1992

MEDICAL STAFF AFFILIATIONS:
Memorial Hospital, Hollywood, FL
Memorial Pembroke,
Pembroke Pines, FL
Memorial West,
Pembroke Pines, FL
Diplomate, American Board of
Family Practice

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE TWO

PROFESSIONAL AFFILIATIONS:
(CONTINUED):

Diplomate, National Board of Examiners for Osteopathic Physicians and Surgeons

Member, Florida Osteopathic Association

Member, American College of Medicine

Member, American Osteopathic Association
Member, Broward County Osteopathic Medical
Association

Member, American College of General Practice

Member, American College of Osteopathic

General Partners in Osteopathic
Medicine and Surgery

Member, Pharmacy and Therapeutics
Committee, Memorial Regional Hospital

Member, Cardiology Review Board, Blue Cross
Blue Shield of Florida

Member, Pharmacy and Therapeutics
Committee, United Health

HOSPITAL APPOINTMENT:
Member-at-Large, Executive Committee
Pembroke Pines General Hospital
1977 - 1979

Co-Chief, Department of Medicine
Pembroke Pines General Hospital
1977 - 1979

Chief, Department of Medicine
Pembroke Pines General Hospital
1979 - 1980

Vice-Chief of Staff
Pembroke Pines General Hospital
1980 - 1981

Member. Board of Directors
Pembroke Pines General Hospital
1981 – 1983

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE THREE

HOSPITAL APPOINTMENT
(CONTINUED):

Chief of Staff
Pembroke Pines General Hospital
1981 - 1983

Immediate Past President, Board of
Directors and Executive Committee
Pembroke Pines General Hospital
1983 - 1985

Chief of Family Practice
Hollywood Memorial Hospital
May 1, 1992 - Present

MEDICAL SCHOOL TEACHING
Instructor, Department of Family

AFFILIATION:
Medicine
University of Miami School of
Medicine, 1973 - 1983

JOURNAL AFFILIATION:
Pre-Publication Reviewer
Patient Care Medicine
1984 - Present

Treatment of Isolated Systolic Hypertension with
Labetalol in the Elderly Archives of Internal
Medicine Vol. 150. May 1990
The Journal of the American Medical Association
Metabolic Effects of Carvedilol vs Metoprolol
In Patients with type 2 Diabetes Mellitus
And Hypertension. A Randomized Controlled
Trial.
JAMA & Archives Journals Vol. 292 No. 18

The American Pain Society’s
Title: Remoxy™: A new opioid drug with
effective analgesia and abuse-resistance
Author(s): Dr. Larry Gilderman1

PRESENTATION:
“Capitation and Risk: Are Providers Ready?”

Will Capitation Kill Health Care March 27, 1996

COMMUNITY SERVICE AFFILIATION:
Examiner, Broward County Paramedics’ Board
1978 - Present

Police Surgeon, City of Pembroke
Pines, FL 1982 - Present

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE FOUR

EXPERIENCE:
Principal Investigator/Medical Director
1984-Present
University Clinical Research, Inc.
1150 N. University Drive
Pembroke Pines, FL 33024

Physician/Medical Director
1975-Present
University Medical Center
1150 N. University Drive
Pembroke Pines, FL 33024

MINI Experience:

Have been performing the Mini International Neuropsychiatric Interview for over 15 years in both the clinical and research practice at least 1000 times a year.

RESEARCH ACTIVITIES:

PINACIDIL AND/OR DIURETIC VS. PLACEBO IN MILD TO MODERATE HYPERTENSION.
ELI LILLY & COMPANY.

A MULTI-CENTER, OBSERVER-BLIND COMPARATIVE STUDY OF ORAL RU965 AND ERYTHROMYCIN ETHLYSUCCINATE IN THE TREATMENT OF PATIENTS WITH INFECTIONS CAUSED BY SUSCEPTIBLE PATHOGENS, HOECHST-ROUSSEL PHARMACEUTICAL.

PINDAC-HCTZ COMBINATION: EFFICACY AND SAFETY IN HYPERTENSION.
ELI LILLY & COMPANY.

A DOUBLE-BLIND, PARALLEL, RANDOMIZED, PLACEBO-CONTROLLED COMPARISON OF "SOMA" COMPOUND AND ITS COMPONENTS. WALLACE LABORATORIES.

MULTI-CENTER RANDOMIZED STUDY OF EVALUATE THE SAFETY AND EFFICACY OF LAXACIN VS. AMOXICILLIN IN THE TREATMENT OF UPPER RESPIRATORY TRACT INFECTION IN ADULTS. ORTHO PHARMACEUTICALS.

EVALUATION OF EFFICACY AND SAFETY OF COMBINATION THERAPY WITH RAMIPRIL PLUS HYDROCHOLROTHIAZIDE VS. MONOTHERAPY WITH EITHER RAMIPRIL OR HYDROCHLOROTHIAZIDE ALONE IN PATIENTS WITH HYPERTENSION. HOECHST-ROUSSEL PHARMACEUTICALS.

EVALUATION OF LABETALOL FOR THE TREATMENT OF ISOLATED SYSTOLIC OR ESSENTIAL HYPERTENSION IN THE ELDERLY. GLAX0.

THE SAFETY AND EFFECTIVENESS OF FOUR DOSES OF BETAXOLOL HCL VS. PLACEBO IN THE HYPERTENSIVE PATIENTS: A MULTI-CENTER, DOUBLE-BLIND, PARALLEL STUDY. LOREX PHARMACEUTICALS.

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE FIVE

RESEARCH ACTIVITIES (CONTINUED):

A MULTI-CENTER RANDOMIZED, DOUBLE-BLIND, PARALLEL COMPARISON OF FOSINOPRIL SODIUM AND ENALAPRIL MALEATE FOR THE TREATMENT OF MILD TO MODERATE ESSENTIAL HYPERTENSION. SQUIBB.

AN OPEN-LABEL STUDY OF MARKETED NSAID TREATMENT IN PATIENTS WITH OSTEOARTHRITIS. CIBA-GEIGY.

AN OPEN-LABEL STUDY OF VOLTAREN TREATMENT IN PATIENT WITH OSTEOARTHRITIS. CIBA-GEIGY.

A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO COMPARE THE EFFICACY OF 100mg AND 200mg DIMETIDENE SWALLOW CAPLETS AND ANTACID SWALLOW CAPLETS IN RELIEVING EPISODIC HEARTBURN/ACID INDIGESTION. SMITH KLINE & FRENCH LABORATORIES.

A PILOT STUDY TO DETERMINE THE EFFECTIVENESS OF VARYING DOSES OF HYDROCHLOROTHIAZIDE WHEN COMBINE WITH DILTIAZEM SR IN PATIENTS WITH MILD TO MODERATE ESSENTIAL HYPERTENSION. MARION LABORATORIES, INC.

A RANDOMIZED, DOUBLE-BLIND, DOSE TITRATION, CROSSOVER, COMPARATIVE STUDY OF AMBULATORY BLOOD PRESSURE RESPONSE TO TREATMENT WITH BETAXOLOL VS. ATENOLOL IN HYPERTENSIVE PATIENTS. G.D. SEARLE AND COMPANY.

A RANDOMIZED, DOUBLE-BLIND PARALLEL GROUP, DOSE RESPONSE STUDY COMPARING THE EFFICACY AND SAFETY OF 5mg, 10mg, AND 20mg OF BISOPROLOL TO PLACEBO GIVEN ONCE DAILY IN PATIENTS WITH MILD OT MODERATE HYPERTENSION. AMERICA CYANAMID COMPANY.

LOVASTATIN DOSE RANGING MULTI-CENTER STUDY IN PATIENTS WITH TYPE II HYPERCHOLESTEROLEMIA, TOTAL CHOLESTEROL 240-300mg/DL WITH OR WITHOUT OTHER FACTORS AND WITH OR WITHOUT EVIDENCE OF CORONARY ARTERY DISEASE. MERCK SHARP AND DOME.

A PROSPECTIVE RANDOMIZED DOUBLE-BLIND TRIAL OF NIFEDIPINE GITS AND ATENOLOL OF THE QUALITY OF LIFE IN MILD TO MODERATE HYPERTENSION. PFIZER.

A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO COMPARE THE EFFICACY OF 200mg AND 400mg CIMETIDINE SWALLOW CAPLET AND AN ANTACID SWALLOW CAPLET IN RELIEVING EPISODIC HEARTBURN/ACID INDIGESTION. SMITH KLINE BEECHAM COMPANY.

PROTOCOL FOR THE MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ISRADIPINE (PN 200-110), ADMINISTERED TWICE A DAY, COMPARED TO PLACEBO, IN THE TREATMENT OF ESSENTIAL HYPERTENSION. SANDOZ RESEARCH INSTITUTE.

AN OPEN LABEL, OBSERVER BLIND, EFFICACY, SAFETY AND TOLERABILITY STUDY COMPARING METOPROLOL FUMARATE OROS AND DYAZIDE IN THE TREATMENT OF PATIENTS WITH MILD TO MODERATE HYPERTENSION. CIBA-GEIGY.

DOUBLE BLIND, DOUBLE CROSSOVER, SINGLE DOSE COMPARISON OF CLIDINIUM BROMIDE WITH PLACEBO IN PATIENTS WITH IRRITABLE BOWEL SYNDROME. HOFFMAN LA-ROCHE.
LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE SIX

RESEARCH ACTIVITIES (CONTINUED):

A MULTI-CENTER COMPARISON OF THE SAFETY AND EFFICACY OF LAMEFLOXACIN AND NORFLOXACIN IN THE TREATMENT OF UNCOMPLICATED URINARY TRACT INFECTION, G.D. SEARLE AND COMPANY.

ORAL CONTRACEPTION WITH NORGESTIMATE VERSUS LO OVRAL.
COMPARATIVE STUDY OF ABBOTT 56268 AND AMPICILLIN IN THE TREATMENT OF OUTPATIENTS WITH AN ACUTE BACTERIAL EXACERBATION OF CHRONIC BRONCHITIS. ABBOTT LABORATORIES.

OGEN AND PREMARIN FOR THE TREATMENT OF VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE. ABBOTT.

COMPARATIVE SAFETY AND EFFICACY OF CLARITHROMYCIN (TE-031) AND ERYTHROMYCIN IN THE TREATMENT OF COMMUNITY ACQUIRED PNEUMONIA. ABBOTT LABORATORIES.

THE SAFETY AND EFFICACY OF TEMAFLOXACIN 600mg BID COMPARED TO CIPROFLOXACIN 750mg BID IN THE TREATMENT OF BACTERIAL SKIN OR SKIN STRUCTURE INFECTION. ABBOTT LABORATORIES.

AZITHROMYCIN IN THE STREPTOCOCCAL PHARYNGITIS IN OUTPATIENTS. A MULTI-CENTER THIRD PARTY BLINDED TRIAL EMPLOYING PENICILLIN V (V CILLIN K) AS A COMPARATIVE AGENT. PFIZER,

AZITHROMYCIN IN THE TREATMENT OF SKIN AND SKIN STRUCTURE INFECTIONS. A MULTI-CENTER THIRD PARTY BLINDED TRIAL EMPLOYING KEFLEX AS A COMPARATIVE AGENT. PFIZER.

COMPARATIVE DOUBLE BLIND STUDY OF THE SAFETY AND EFFICACY OF ONCE DAILY DOSES OF NIFEDIPIN 30, 60, AND 90mg CORE COAT TABLETS vs. PLACEBO IN HYPERTENSIVE PATIENTS. MILES.

A PHASE III, MULTI-CENTER, DOUBLE-BLIND, PARALLEL GROUP, PROSPECTIVE RANDOMIZED COMPARATIVE STUDY OF CEFPODOXIME PROXETIL AND AMOXICILLIN IN THE TREATMENT OF OUTPATIENTS WITH UNCOMPLICATED URINARY TRACT INFECTIONS. SANKYO.

TRAMADOL HYDROCHLORIDE: SAFETY AND EFFICACY COMPARED TO ACETAMINOPHEN WITH CODEINE PHOSPHATE IN ELDERLY PATIENTS WITH CHRONIC PAIN. McNEIL.

A DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO DEMONSTRATE THE EFFICACY OF SOMA COMPOUND AND THE CONTRIBUTION OF THE INDIVIDUAL INGREDIENTS (CARISOPRODOL: ASPIRIN) TO THE OVERALL EFFECT OF THE COMBINATION IN THE TREATMENT OF THE ACUTE PAINFUL MUSCULOSKELETAL CONDITIONS OF THE LOWER BACK. CARTER WALLACE.

A RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP STUDY COMPARING THE EFFICACY AND SAFETY OF PLACEBO, BISOPROLOL 5mg, BISOPROLOL 5mg AND HCTZ 6.25mg, AND

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE SEVEN

RESEARCH ACTIVITIES (CONTINUED):

HCTZ 25mg GIVEN ONCE DAILY IN PATIENTS WITH MILD TO MODERATE ESSENTIAL HYPERTENSION. AMERICAN CYANAMID.

ORAL CONTRACEPTION 092-002 WITH CTR 99 VERSUS CTR 77 VERSUS ORTHO NOVUM 7/7/7.

THE CONTROL OF PAIN IN THE TREATMENT OF ACUTE ANAL FISSURES, PARKE DAVIS.

A MULTI-CENTER EVALUATION OF ROBAXISAL WITH CODEINE FOR EFFICACY, SAFETY AND CONTRIBUTION OF COMPONENT INGREDIENTS. A.H. ROBBINS COMPANY

A STUDY OF SUCRALFATE vs. PLACEBO IN THE SYMPTOMATIC RELIEF OF RECURRENT UPSET STOMACH. SCHERING-PLOUGH.

A LONG TERM, OPEN-LABEL EXTENSION FOR PATIENTS COMPLETING STUDY S89-046. SCHERING-PLOUGH.

A DOUBLE-BLIND, PLACEBO CONTROLLED COMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF NIFEDIPINE SUSTAINED RELEASE (SR) TABLETS TITRATED FROM 20mg TO 100mg DAILY vs. VERAPAMIL SR TABLETS TITRATED FROM 240mg TO 480mg DAILY IN PATIENTS WITH MILD TO MODERATE HYPERTENSION. MILES, INC.

A COMPARATIVE TRIAL OF CEFPROZIL (500mg BID) vs. CEFUROXIME AXETIL (500mg BID) IN THE TREATMENT OF MILD TO MODERATE LOWER RESPIRATORY TRACT INFECTIONS. BRISTOL MYERS.

COMPARATIVE DOUBLE-BLIND TRIAL COMPARING THE EFFICACY OF ONCE DAILY DOSES OF NIFEDIPINE 30. 60, AND 90mg CORE COAT TABLES vs. PLACEBO IN HYPERTENSIVE PATIENTS. MILE.

A PROSPECTIVE RANDOMIZED DOUBLE-BLIND TRIAL COMPARING THE EFFECTS OF CAPTOPRIL AND ENALAPRIL ON QUALITY OF LIFE IN THE OLDER HYPERTENSIVE PATIENTS. SQUIBB U.S. PHARMACEUTICAL.

A DOUBLE-BLIND RANDOMIZED STUDY OF THE SAFETY AND EFFICACY OF ONCE DAILY DOSES OF NISOLDIPINE COAT-CORE TABLETS 30mg, 60mg (2 X 30) vs. PLACEBO IN HYPERTENSIVE PATIENTS. MILES, INC.

A DOSE-RESPONSE STUDY OF TEBUFELONE IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE. PROCTER AND GAMBLE.

DOUBLE-BLIND, PLACEBO-CONTROLLED EVALUATION OF THE EFFICACY AND SAFETY OF 600mg TRENTAL (PENTOXIFYLLINE) TABLETS IN PATIENTS WITH INTERMITTENT CLAUDICATION. HOECHST-ROUSSEL PHARMACEUTICALS, INC.

TRAMADOL HYDROCHLORIDE: SAFETY AND EFFICACY COMPARED TO ACETAMINOPHEN WITH CODEINE PHOSPHATE IN ELDERLY PATIENTS WITH CHRONIC PAIN. McNEIL.

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE EIGHT

RESEARCH ACTIVITIES (CONTINUED):

A COMPARISON OF THE SAFETY AND EFFICACY OF LOMEFIOXACIN AND CIPROFIOXACIN IN THE TREATMENT OF NON-NECROTIZING SKIN AND SKIN STRUCTURE INFECTIONS. G.D. SEARLE AND CO.

A MULTI-CENTER COMPARISON OF THE SAFETY AND EFFICACY OF LOMEFIOXACIN AND OFIOXACIN IN THE TREATMENT OF CHRONIC BACTERIAL PROSTATITIS. G.D. SEARLE AND CO.

LORACARBEF vs. DEFTIN IN ACUTE EXACERBATION OF CHRONIC BRONCHITIS. ELI LILLY AND CO.

A DOUBLE-BLIND RANDOMIZED STUDY OF THE SAFETY AND EFFICACY OF ONCE QD DOSES OF NISOLFIPINE COAT CORE TABLETS 30mg, 60mg, (2 X 30mg), AND 90mg (3 X 30mg) vs. PLACEBO IN HYPERTENSIVE PATIENTS. MILES.

A DOUBLE-BLIND PLACEBO CONTROLLED COMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF NIFIDIPINE SUSTAINED-RELEASE (SR) TABLETS TITRATED FROM 20mg TO 100mg DAILY vs. VERAPAMIL SR TABLETS TITRATED FROM 240mg TO 480mg DAILY IN PATIENTS WITH MILD TO MODERATE HYPERTENSION. PFIZER.

MULTI-CENTER, PROSPECTIVE, RANDOMIZED, SINGLE-DOSE, DOUBLE-BLIND, PARALLEL DESIGN COMPARISON OF THE ANTIPYRETIC ACTIVITY OF KETOPROFEN 12.5 AND 25mg (2 X 12.5mg) vs. ACETAMINOPHEN 650mg (2 X 325mg) AND PLACEBO IN ADULT PATIENTS WITH PYREXIA DUE TO UPPER RESPIRATORY TRACT INFECTIONS. MILES.

DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF BAY W 9798 IN PATIENT WITH INTERMITTENT CLAUDICATION. MILES.

COMPARISON OF FOSINOPRIL SODIUM AND NIFEDIPINE GITS IN OLDER PATIENT WITH MILD TO MODERATE ESSENTIAL HYPERTENSION WITH THE ADDITION OF LOW-DOSE HYDROCHLOROTHIAZIDE FOR NON-RESPONDERS. BRISTOL MYERS SQUIBB.

A DOUBLE-BLIND DOSE RANGING STUDY OF BAY W 6228 IN DOSES OF 50uG, 200uG AND 300uG ONCE DAILY COMPARED TO PLACEBO AND TO LOVASTATIN 40mg ONCE DAILY IN PATIENTS WITH HYPERCHOLESTEROLEMIA. MILES.

DOUBLE-BLIND, RANDOMIZED, COMPARATIVE, MULTI-CENTER STUDY OF RP 64206 (SPARFLOXACIN) vs. OFLOXACIN IN THE TREATMENT OF ACUTE BACTERIAL EXACERBATION OF CHRONIC BRONCHITIS. RHONE POULENC RORER.

DOUBLE-BLIND, RANDOMIZED, COMPARATIVE, MULTI-CENTER STUDY OF RP 64206 (SPARFLOXACIN) vs. CIPROFLOXIN IN THE TREATMENT OF COMMUNITY-ACQUIRED, COMPLICATED/SEVERE UNCOMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS. RHONE POULENC RORER.

H2B-341 A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER OF ORAL GR122311X COMPARED WITH RANITIDINE AND GR88502X FOR THE PROPHYLAXIS OF NON-STEROIDAL ANTI-INFLAMMATORY DRUG-ASSOCIATED GASTRIC OR DUODENAL ULCERS IN PATIENTS WITH OSTEO OR RHEUMATOID ARTHRITIS AND WITHOUT A HISTORY OF GASTRIC OR DUODENAL ULCERS. GLAXO.
LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE NINE

RESEARCH ACTIVITIES (CONTINUED):

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP DOSE RESPONSE STUDY OF TEMOCAPRIL HCI (CS-622) IN PATIENTS WITH MILD TO MODERATE ESSENTIAL HYPERTENSION: 0, 10, 20, 40, AND 80mg DOSES. SANKYO.

OPEN-LABEL, LONG-TERM SAFETY OF RO40-5967 IN THE TREATMENT OF ESSENTIAL HYPERTENSION. HOFFMAN LA-ROCHE, INC.

A MULTI-CENTER, CONTROLLED EVALUATION OF THE SAFETY AND EFFICACY OF REPEATED ORAL DOSES OF VICOPROFEN (HYDROCODIENE BITARTRATE WITH IBUPROFEN) FOR THE TREATMENT OF CHRONIC PAIN. KNOLL PHARMACEUTICALS.

A DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-FINDING STUDY OF THE SAFETY AND EFFICACY OF THREE DOSAGE REGIMENS OF FLEXERIL IN OUTPATIENTS WITH ACUTE SKELETAL MUSCLE SPASM. MERCK RESEARCH LABORATORIES.

A DOUBLE-BLIND, FIXED-DOSE, MULTI-CENTER STUDY COMPARING DN-2327 (4 AND 8mg/DAY) TO BUSPIRONE (25mg/DAY) AND PLACEBO IN PATIENTS WITH GENERALIZED ANXIETY DISORDER. TAP.

A DOUBLE-BLIND, DOSE-RANGING STUDY OF BAY w 6228 IN DOSES OF 50uG, 100uG, AND 200uG ONCE DAILY COMPARED TO PLACEBO AND TO LOVASTATIN 40mg ONCE DAILY IN PATIENTS WITH HYPERCHOLESTEROLEMIA. MILES PHARMACEUTICAL DIVISION.

CLINICAL PHASE III: DILTIAZEM ER/ENALAPRIL COMBINATION THERAPY IN HYPERTENSIVE PATIENTS NOT RESPONDING ADEQUATELY TO DILTIAZEM CD (CARDIZEM CD) MONOTHERAPY, EDPROO1, MARION MERRILL DOW, INC.

CALCIUM ANTAGONIST OPEN LABEL, LONG TERM SAFETY OF RO40-5967 IN THE TREATMENT OF ESSENTIAL HYPERTENSION. ROCHE.

CALCIUM ANTAGONIST OPEN-LABEL, LONG TERM SAFETY OF RO40-5967 IN THE TREATMENT OF CHRONIC STABLE ANGINA. ROCHE.

A RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, PARALLEL STUDY TO COMPARE THE DURATION OF THE ANTIHYPERTENSIVE EFFECT AND SAFETY OF FOUR DOSE LEVELS OF TAK-536 WITH THAT OF PLACEBO IN PATIENTS WITH MODERATE UNCOMPLICATED ESSENTIAL HYPERTENSION. G.H. BESSELAAR ASSOCIATES.

A PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED COMPARISON OF TWO TREATMENT REGIMENS: COZAAR AND HYZAAR vs. VASOTEC AND VASOTEC PLUS 25mg HYDROCHLOROTHIAZIDE (EQUIVALENT TO THE COMBINATION DRUG VASERETIC 10/25mg) IN THE TREATMENT OF PATIENTS WITH MILD TO MODERATE HYPERTENSION MK 954-CO2335. MERCK & CO.

A DOUBLE-BLIND, TWELVE WEEK STUDY TO COMPARE THE SAFETY AND TOLERABILITY OF THE (S+) ENAMTIOMER OF IBUPROFEN AND RACEMIC IBUPROFEN IN THE TREATMENT OF PAIN DUE TO OSTEOARTHRITIS, CHG 94-1. STERLING HEALTH DIVISION OF STERLING WINTHROP, INC.
LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE TEN

RESEARCH ACTIVITIES (CONTINUED):

A MULTI-CENTER, PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED PARALLEL STUDY TO COMPARE THE EFFICACY AND TOLERABILITY OF 10mg, 20mg, AND 40mg DOSES OF LOVASTATIN vs. 20mg AND 40mg OF FLUVASTATIN IN THE TREATMENT OF PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA, 073. MERCK.

A PHASE II, DOUBLE-BLIND, PLACEBO CONTROLLED, DOSE-RANGE AND SHORT TERM EFFICACY STUDY OF UP269-6 IN HYPERTENSIVE PATIENTS, GHBA-811. G.H. BESSELAAR ASSOCIATES.

A DOUBLE-BLIND AMBULATORY BLOOD PRESSURE MONITORING STUDY OF TEMOCAPRIL HCL (CS-622) IN PATIENTS WITH MILD TO MODERATE ESSENTIAL HYPERTENSION, 622-314. SANKYO.

LABEL COMPREHENSION AND ACTUAL USE STUDY OF ZANTAC 75mg AMONG OTC CONSUMERS , ROC-302. GLAXO, INC.

LONG-TERM SURVEILLANCE STUDY OF ZILEUTON PLUS USUAL CARE vs. USUAL CARE IN PATIENTS WITH ASTHMA, M94-199. ABBOTT LABORATORIES.

CATAPRES-ITS vs. AMLODIPINE IN THE TREATMENT OF PATIENTS WITH MILD TO MODERATE HYPERTENSION, 1068A. BOEHRINGER INGELHEIM PHARMACEUTICALS, INC.

A MULTI-CENTER, DOUBLE-BLIND PLACEBO CONTROLLED, REPLICATIVE PIVOTAL SAFETY AND EFFICACY STUDY OF TWO DOSAGE REGIMENS OF FLEXERIL (5mg AND 2.5mg) IN OUTPATIENTS WITH ACUTE SKELETAL MUSCULAR SPASM, GHBA-927. MERCK RESEARCH LABORATORIES.

A RANDOMIZED, DOUBLE-BLIND TRIAL COMPARING THREE DAYS AND SEVEN DAYS OF ORAL THERAPY WITH CP-99,219 (100mg DAILY) AND THREE DAYS THERAPY WITH NORPLOXACIN (400mg BID) FOR THE TREATMENT OF UNCOMPLICATED ACUTE URINARY TRACT INFECTION. PFIZER, 1NC.

A MULTI-CENTER TRIAL OF THE ANTIHYPERTENSIVE ACTIVITY AND SAFETY OF IRBESARTAN IN PATIENTS WITH MILD TO MODERATE HYPERTENSION. BRISTOL-MYERS SQUIBB COMPANY.

A RANDOMIZED, DOUBLE-BLIND, PARALLEL TRIAL COMPARING LOTREL 5/10 mg ONCE DAILY, LOTREL 5/20 Mg ONCE DAILY, AMLODIPINE 5 Mg ONCE DAILY, AND AMLODIPINE 10 Mg ONCE DAILY IN PATIENTS AGE 18 - 80 YEARS WITH ESSENTIAL HYPERTENSION INADEQUATELY CONTROLLED WITH AMLOKIPINE 5 Mg ONCE DAILY FOLLOWED BY A SINGLE-BLIND EXTENSION OF LOTREL 5/20 Mg ONCE DAILY. CIBA-GEIGY.

OPEN EVALUATION OF THE SAFETY AND EFFICACY OF MAINTENANCE THERAPY WITH ORAL ANA-756 IN THE TREATMENT OF PATIENTS WITH ESSENTIAL HYPERTENSION (PR 820-307-US). WYETH-AYERST RESEARCH.

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE ELEVEN

RESEARCH ACTIVITIES (CONTINUED):

A RANDOMIZED, DOUBLE-BLIND MULTI-CENTER PILOT TRIAL OF ONCE DAILY ECADOTRIL (400mg, 600mg, AND 800mg) vs. PLACEBO IN ESSENTIAL HYPERTENSION. BAYER

A MULTI-CENTER, OPEN-LABEL, RANDOMIZED STUDY TO COMPARE THE EFFECT OF OMEPRAZOLE TRIPLE THERAPY REGIMENS TO DUAL THERAPY REGIMENS ON HELICOBACTER PYLORI ERADICATION IN PATIENTS WITH HELICOBACTER PYLORI INFECTION. ASTRA-MERCK.

ONE-YEAR COMPARISON OF REPAGLINIDE AND GLYBURIDE FOR THE TREATMENT OF TYPE II DIABETES.

A RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER PROGESTIN EFFICACY STUDY OF THREE DOSES OF RPR ESTRADIOL/NORETHISTERONE ACETATE (NETA) PATCHES IN A CONTINUOUS WEAR HRT REGIMEN COMPARED TO AN ESTRADIOL 50mg PATCH. RHONE-POULENC RORER PHARMACEUTICALS, INC.

"ESTRADIOL THROUGH THE AGES": A PLACEBO CONTROLLED, RANDOMIZED, AGE-STRATIFIED MULTI-CENTER STUDY OF THE SAFETY, TOLERABILITY AND EFFECTIVENESS OF ESTRACE IN THE TREATMENT OF OSTEOPOROSIS IN POST-MENOPAUSAL WOMEN 55 YEARS OF AGE OR OLDER. CORNING PACT.

A DOUBLE-BLIND COMPARISON OF TWO DOSES OF NABUMETONE COMPARED WITH PLACEBO ADMINISTERED ONCE DAILY IN THE MORNING IN THE TREATMENT OF ACUTE ONSET PARASPINAL PAIN (PR-217). SMITHKLINE BEECHAM PHARMACEUTICALS.

A DOUBLE-BLIND COMPARISON OF TWO DOSES OF NABUMETONE COMPARED WITH PLACEBO ADMINISTERED ONCE DAILY IN THE MORNING IN THE TREATMENT OF ACUTE ONSET LARGE MUSCLE BUNDLE PAIN (PR-215). SMITHKLINE BEECHAM PHARMACEUTICALS.

LONG TERM TRIAL OF THE EFFICACY AND SAFETY OF TELMISARTAN (BIBR-277 SE) COMPARED WITH LISINOPRIL IN PATIENTS WITH MILD TO MODERATE HYPERTENSION. BOEHRINGER INGELHEIM.

A DOUBLE-BLIND, RANDOMIZED, VEHICLE-CONTROLLED, PARALLEL GROUP DOSE-RANGING MULTI-CENTER STUDY EVALUATING THE SAFETY AND EFFICACY OF CIVAMIDE CREAM 0.15%, 0.3%, AND 0.6% IN SUBJECTS WITH OSTEOARTHRITIS OF THE KNEE. GENDERM CORPORATION.

A BLINDED, RANDOMIZED PARALLEL GROUP SAFETY AND EFFICACY EVALUATION OF PHZ-136 COMPARED TO COMMERCIALLY AVAILABLE IBUPROFEN IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE. ZAMBON LABORATORIES.

RELIEF OF EPISODIC HEARTBURN: SAFETY AND EFFICACY OF NIZATIDINE 75mg. A PLACEBO CONTROLLED STUDY. WHITEHALL-ROBINS.

A COMPARATOR STUDY OF THE ANALGESIC EFFECT OF LY303870 DIHYDROCHLORIDE TRIHYDRATE IN PATIENTS WITH OSTEOARTHRITIS PAIN. LILLY RESEARCH LABORATORIES.
LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
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RESEARCH ACTIVITIES (CONTINUED):

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 4 X 5 FACTORIAL TRIAL OF TELMISARTAN AND HYDROCHLOROTHIAZIDE IN PATIENTS WITH MILD-TO-MODERATE ESSENTIAL HYPERTENSION. BOEHRINGER INGELHEIM.

A COMPARISON OF EFFICACY AND SAFETY OF MIBEFRADIL AND NIFEDIPINE GITS OR ENALAPRIL FOR THE TREATMENT OF MILD-TO-MODERATE HYPERTENSION. HOFFMAN LA-ROCHE.

TRANDOLAPRIL IN HYPERTENSION: EFFECTIVENESS WHEN ADDED TO VERAPAMIL SR. KNOLL PHARMACEUTICAL COMPANY.

EVALUATION OF THE EFFICACY AND SAFETY OF CANDESARTAN CILEXETIL IN THE TREATMENT OF PATIENTS WITH HYPERTENSION: A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RESPONSE STUDY. ASTRA MERCK.

EFFICACY AND TOLERABILITY OF FELODIPINE ER IN THE TREATMENT OF STAGE I (JNC V) SYSTOLIC HYPERTENSION IN OLDER PATIENTS OVER A ONE YEAR PERIOD. ASTRA MERCK.

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RANGING STUDY OF CS-866 USING AMBULATORY BLOOD PRESSURE MONITORY IN HYPERTENSIVE PATIENTS. SANKYO USA, CORPORATION.

AN OPEN-LABEL EVALUATION OF THE SAFETY OF CHRONIC ADMINISTRATION OF TELMISARTAN AS MONOTHERAPY OR IN COMBINATION WITH OTHER ANTIHYPERTENSIVE MEDICATIONS. BOEHRINGER INGELHEIM.

A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF TIMED MEDICATIONS IN THE TREATMENT OF OBESE TYPE II DIABETICS.

MULTI -CENTER, DOUBLE BLIND STUDY TO COMPARE THE SAFETY AND EFFICACY OF LOVASTATIN AND PROBUCOL IN PATIENTS WITH NON-INSULIN DEPENDENT DIABETES MELLITUS (NIDDM). MERCK SHARP AND DOME.

AN OPEN-LABELED RANDOMIZED PARALLEL GROUP COMPARATIVE MULTI-CENTER SAFETY AND EFFICACY STUDY OF TRIPHASIC COMBINATION OF ORAL CONTRACEPTIVES VERSUS ORTHO NOVUM 7/7/7.

COMPARISON OF CEFPAIOXIME PROXETIL (U-76, 252) AND CEFACLOR (CECLOR) IN THE TREATMENT OF ACUTE COMMUNITY ACQUIRED PNEUMONIA. UPJOHN.

THE SAFETY AND EFFICACY OF DILTIAZEM QD vs. PLACEBO IN THE TREATMENT OF ESSENTIAL HYPERTENSION. PROTOCOL DZPRO100 MARION MERRELL DOW.

DIRITHROMYCIN vs. ERYTHROMYCIN BASE IN PNEUMONIA, BRONCHITIS, PHARYNGITIS, AND SKIN INFECTIONS. ELI LILLY.

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE THIRTEEN

RESEARCH ACTIVITIES (CONTINUED):

A MULTI-CENTER, ACTIVE CONTROLLED, RANDOMIZED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ORAL L-OFIOXACIN vs. CEFACLOR IN THE TREATMENT OF LOWER RESPIRATORY TRACT INFECTIONS IN ADULTS. R.W. JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE.

TWELVE WEEK, DOUBLE-BLIND STUDY OF TROGLITAZONE vs. PLACEBO IN NIDDM PATIENTS REQUIRING INSULIN.

(MICONAZOLE NITRATE 2%) VAGINAL CREAM IN THE TREATMENT OF PATIENTS WITH VULVOVAGINAL CANDIDIASIS. BRISTOL MEYERS SQUIBB.

A RANDOMIZED, DOUBLE- BLIND PLACEBO CONTROLLED, FACTORIAL-DESIGN TRIAL OF ANA-756 ALONE AND IN COMBINATION WITH HYDROCHLOROTHIAZIDE IN PATIENTS WITH ESSENTIAL HYPERTENSION. WYETH-AYERST RESEARCH.

A SIX-MONTH RANDOMIZED, SINGLE DAILY DOSE, DOUBLE-BLIND PARALLEL GROUP MULTI-CENTER STUDY TO COMPARE PIROZICAM-BETA-CYCLODEXTRIN AND FELDENE FOR SAFETY, TOLERABILITY AND SYMPTOMATIC RELIEF IN PATIENTS WITH OSTEOARTHRITIS. CHIESI FARMACEUTICI S.P.A.

DOSE-RESPONSE STUDY OF THE ANALGESIC EFFECT OF LY297802 TARTRATE IN PATIENTS WITH OSTEOARTHRITIS PAIN (PR H3Q-MC-CCCD-117). ELI-LILLY AND COMPANY.

A RANDOMIZED DOUBLE-BLIND PLACEBO CONTROLLED PARALLEL MULTI-CENTER STUDY OF MOEXIPRIL IN POSTMENOPAUSAL HYPERTENSIVE WOMEN WHO ARE USING HORMONE REPLACEMENT THERAPY.

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, EVALUATION OF A ZANTAC 75/CALCIUM CARBONATE COMBINATION TABLET COMPARED TO ZANTAC 75 ALONE AND CALCIUM CARBONATE ALONE FOR THE TREATMENT OF EPISODIC HEARTBURN. GLAXOWELLCOME

THE SAFETY AND EFFICACY OF DILTIAZEM QD vs. PLACEBO IN THE TREATMENT OF ESSENTIAL HYPERTENSION. PROTOCOL DZPRO100 MARION MERRELL DOW.

DIRITHROMYCIN vs. ERYTHROMYCIN BASE IN PNEUMONIA, BRONCHITIS, PHARYNGITIS, AND SKIN INFECTIONS. ELI LILLY.

TWELVE WEEK, DOUBLE-BLIND STUDY OF TROGLITAZONE vs. PLACEBO IN NIDDM PATIENTS REQUIRING INSULIN.

(MICONAZOLE NITRATE 2%) VAGINAL CREAM IN THE TREATMENT OF PATIENTS WITH VULVOVAGINAL CANDIDIASIS. BRISTOL MEYERS SQUIBB
LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE FOURTEEN

RESEARCH ACTIVITIES (CONTINUED):
.

A RANDOMIZED, DOUBLE- BLIND PLACEBO CONTROLLED, FACTORIAL-DESIGN TRIAL OF ANA-756 ALONE AND IN COMBINATION WITH HYDROCHLOROTHIAZIDE IN PATIENTS WITH ESSENTIAL HYPERTENSION. WYETH-AYERST RESEARCH.

DOSE-RESPONSE STUDY OF THE ANALGESIC EFFECT OF LY297802 TARTRATE IN PATIENTS WITH OSTEOARTHRITIS PAIN (PR H3Q-MC-CCCD-117). ELI-LILLY AND COMPANY.

A RANDOMIZED DOUBLE-BLIND PLACEBO CONTROLLED PARALLEL MULTI-CENTER STUDY OF MOEXIPRIL IN POSTMENOPAUSAL HYPERTENSIVE WOMEN WHO ARE USING HORMONE REPLACEMENT THERAPY.

TRAMADOL WITH ACETAMINOPHEN IN LOW BACK PAIN OF NON-MALIGNANT ORIGIN. R.W. JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE.

TRAMADOL WITH ACETAMINOPHEN IN THE PAIN OF OSTEOARTHRITIS OF THE HIP OR KNEE. R,W, JOHNSON PHARMACEUTICAL RESEARCH INSTITUTE.

AN INVESTIGATOR BLINDED MULTI-CENTER TRIAL COMPARING THE EFFICACY AND SAFETY OF VAGISTAT - 1 (TIOCONZAOLE 6.5%) VAGINAL OINTMENT AND MONISTAT – 7 (MICONAOLE NITRATE 2%) VAGINAL CREAM IN THE TREATMENT OF PATIENTS WITH VULVOVAGINAL CANDIDIAS. PHOENIX.

PROTOCOL FOR A MULTICENTRE, LONG TERM STUDY TO MAXIMIXE MIGRAINE RELIEF WITH 311C90 (MAXIM). ZENECA .

A RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND, 12 MONTH, DOSE-RANGING, MULTI-CENTER STUDY PROTOCOL TO DETERMINE THE LOWEST EFFECTIVE CONTINUOUS AND SEQUENTIAL TRANSDERMAL NETA DOSE REQUIRED TO PREVENT ESTROGEN-INDUCED ENDOMETRIAL HYPERPLASIA. PROCTER AND GAMBLE.

A RANDOMIZED, DOUBLE-BLIND PLACEBO CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A SINGLE DOSE OF ALNIDITAN (0.4, 0.8 OR 1.4mg) GIVEN SUBCUTANEOUS IN THE ACUTE TREATMENT OF MIGRAINE. JANSSEN PHARMACEUTICA

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 24 MONTH, DOSE-RANGING, MULTI-CENTER STUDY PROTOCOL COMPARING EMTDS TO PLACEBO IN THE PREVENTION OF BONE LOSS IN HYSTERECTOMIZED POSTMENOPAUSAL WOMEN. PROCTER AND GAMBLE.
LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE FIFTEEN

RESEARCH ACTIVITIES (CONTINUED):

A MULTI-CENTER, PROSPECTIVE, RANDOMIZED, SINGLE-BLIND, PARALLEL-GROUP COMPARISON OF THE SAFETY AND EFFICACY OF THE CLOTRIMAZOLE 1-DAY REGIMENT (500MG VAGINAL INSERT) WITH THE CLOTRIMAZOLE 7-DAY REGIMEN(100MG VAGINAL INSERT) IN THE TREATMENT OF VULVOVAGINAL CANDIDIASIS. BAYER CORPORATION.

A DOUBLE-BLIND, RANDOMIZED, ACTIVE CONTROLLED, PARALLEL STUDY COMPARING ETHICAL ESTRADIOL TO 7-DAY PATCH 40, 60, AND 80 ug/DAY TO ORAL PREMARIN 0.625mg/DAY IN THE TREATMENT OF VASOMOTOR SYMPTOMS IN POSTMENOPAUSAL WOMEN. ETHICAL PHARMACEUTICALS LIMITED.

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP ASSESSMENT OF THE MAGNITUDE AND DURATION OF THE ANTIHYPERTENSIVE EFFECT OF TELMISARTAN ADMINISTERED ONCE-DAILY: EITHER 1 HOUR BEFORE BREAKFAST OR WITH BREAKFAST. BOEHRINGER INGELHEIM. 1997

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND TRIAL OF THE ANTIHYPERTENSIVE EFFICACY AND SAFETY OF IRBESARTAN COMPARED WITH LOSARTAN FOR THE TREATMENT OF MILD-TO-MODERATE HIGH BLOOD PRESSURE. BRISTOL-MYERS SQUIBB COMPANY.

A RANDOMIZED DOUBLE-BLIND MULTI-CENTER PROGESTIN EFFICACY STUDY OF THREE DOSES OF ESTRADIOL/NORETHISTERONE ACETATE (NETA) PATCHES IN A SEQUENTIAL WEAR HRT REGIME COMPARED TO AN ESTRADIOL 50 PATCH.

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND TRIAL OF THE ANTIHYPERTENSIVE EFFICACY AND SAFETY OF IRBESARTAN IN ELDERLY SUBJECTS WITH MILD-TO-MODERATE HYPERTENSION. BRISTOL-MYERS SQUIBB COMPANY.

A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED SIX MONTH SAFETY AND EFFICACY TRIAL OF 7.5, 15, 30, 45mg QD OF PIOGLITAZONE IN TYPE II DIABETES MELLITUS PATIENTS (NON-INSULIN DEPENDENT DIABETES MELLITUS, (NIDDM). CORNING BESSELAAR.

A MULTICENTER, OPEN-LABEL, RANDOMIZED STUDY TO COMPARE THE TOLERABILITY OF TEN DAY OMEPRAZOLE TRIPLE THERAPY TO FOURTEEN DAY STANDARD TRIPLE THERAPY IN SUBJECTS RECEIVING TREATMENT FOR HELICOBACTER PYLORI ERADICATION. ASTRA-MERCK.

A RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED MULTICENTER STUDY MEASURING THE EFFECTS OF CI-991 ON NONINSULIN DEPENDENT DIABETES MELLITUS (NIDDM) PATIENTS REQUIRING INSULIN. PARKE-DAVIS MEDICAL RESEARCH.

A 26-WEEK RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PLACEBO-CONTROLLED, COMPARISON STUDY TO EVALUATE THE SAFETY, EFFICACY, AND TOLERABILITY OF BRL-49653C THERAPY WHEN ADMINISTERED TO PATIENTS WITH NON-INSULIN DEPENDENT DIABETES MELLITUS (NIDDM). SMITHKLINE BEECHAM PHARMACEUTICALS.

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE SIXTEEN

RESEARCH ACTIVITIES (CONTINUED):

OPEN EVALUATION OF THE LONG-TERM EFFICACY, SAFETY AND TOLERABILITY OF 1.4mg SC ALNIDITAN IN THE ACUTE TREATMENT OF MIGRAINE ATTACKS. JANSSEN PHARMACEUTICA.

A MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF 25mg, 100mg, AND 400mg SC-58635 BID VERSUS PLACEBO IN TREATING THE SIGN AND SYMPTOMS OF OSTEOARTHRITIS OF THE KNEE.. G. D. SEARLE AND COMPANY.

A LONG TERM, MULTICENTER STUDY TO EVALUATE THE TOLERABILITY OF PRAMLINTIDE (AC 137) IN PATIENTS WITH TYPE I DIABETES MELLITUS. AMYLIN.

A DOUBLE-BLIND, PLACEBO CONTROLLED, RANDOMIZED COMPARISON STUDY OF THE EFFICACY AND SAFETY OF SC-58635 50mg, 100mg, AND 200mg BID AND NAPROXEN 500mg BID IN TREATING THE SIGN AND SYMPTOMS OF OSTEOARTHRITIS OF THE HIP.
G. D. SEARLE AND COMPANY.

A COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF CLARITHROMYCIN EXTENDED RELEASE TABLETS AND LARACARBEF PULVULES FOR THE TREATMENT OF PATIENTS WITH SECONDARY BACTERIAL INFECTIONS OF ACUTE BRONCHITIS. ABBOTT LABORATORIES.

A STUDY OF COMPARED LANSOPRAZOLE TO RANITIDINE IN PATIENTS WITH HEARTBURN. TAP HOLDINGS INC.

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO AND ACTIVE-CONTROLLED, PARALLEL 8 WEEK DOSE-RANGING STUDY OF THE DUAL METALLOPROTEASE INHIBITOR, BMS-186716, IN THE TREATMENT OF MILD TO MODERATE HYPERTENSION. BRISTOL-MYERS SQUIBB CO.

OPEN-LABEL, LONG-TERM STUDY OF THE ANTIHYPERTENSIVE ACTIVITY AND SAFETY OF BMS-186716, A DUAL METALLOPROTEASE INHIBITOR, IN THE TREATMENT OF HYPERTENSION. BRISTOL-MYERS SQUIBB COMPANY.

A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF 30 mg PIOGLITAZONE DAILY IN PATIENTS WITH NON-INSULIN DEPENDENT DIABETES MELLITUS (NIDDM). TAKEDA AMERICA.

A STUDY TO EVALUATE THE EFFECTS OF LANSOPRAZOLE 30 mg QD OR 15 mg QD VERSUS PLACEBO IN PATIENTS WITH NON-ULCER DYSPEPSIA. TAP HOLDINGS INC.

A DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF EFFICACY AND SAFETY OF SUSTAINED RELEASE DEXFENFLURAMINE IN OBESE OUTPATIENTS. WYETH-AYERST RESEARCH.

EVALUATION OF THE ANTIHYPERTENSIVE EFFECT OF CANDESARTAN CILEXETIL IN COMPARISON TO LOSARTAN: A DOUBLE BLIND, MULTICENTER, PARALLEL DESIGN, RANDOMIZED STUDY: THE CANDLE STUDY. ASTRA MERCK, INC.

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE SEVENTEEN

RESEARCH ACTIVITIES (CONTINUED):

A 26-WEEK RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY AND TOLERABILITY OF BRL 49653C 4 mg BID WHEN ADMINISTERED TO PATIENTS WITH NIDDM WHO ARE INADEQUATELY CONTROLLED ON A MAINTENANCE DOSE (2.5G/DAY) OF METFORMIN. SMITH-KLINE BEECHAM.

CARING FOR HYPERTENSION ON INITIATION: COSTS AND EFFECTIVENESS (CHOICE PILOT). BRISTOL MYERS SQUIBB.

A COMPARISON OF EFFICACY AND SAFETY OF MIBEFRADIL WITH LOSARTAN IN PATIENTS WITH MILD TO MODERATE HYPERTENSION. ROCHE.

A RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP EVALUATION OF CERIVASTATIN 0.8 mg COMPARED TO CERIVASTATIN 0.4 mg AND PLACEBO PRAVASTATIN 40 mg ONCE DAILY IN PATIENTS WITH HYPERCHOLESTEROLEMIA. BAYER.

A DOUBLE-BLIND COMPARISON OF TWO DOSE REGIMENS OF GATIFLOXACIN AND CIPROFLOXACIN IN THE TREATMENT OF WOMEN WITH ACUTE, UNCOMPLICATED URINARY TRACT INFECTION. BRISTOL-MYERS SQUIBB.

A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED TRIAL OF THE EFFECT OF WEEKLY AZITHROMYCIN ON THE INCIDENCE OF CORONARY ARTERY DISEASE IN SUBJECTS WITH EVIDENCE OF EXPOSURE TO C. PNEUMONIAE. PFIZER.

PLACEBO-CONTROLLED COMPARATIVE TRIAL OF IRBESARTAN 300 mg AND LOSARTAN 100 mg IN SUBJECTS WITH MILD-TO-MODERATE HYPERTENSION. BRISTOL-MYERS SQUIBB.

A MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY EVALUATING OMEPRAZOLE MAGNESIUM, 10.3 mg and 20.6 mg DAILY, FOR THE TREATMENT OF EPISODIC HEARTBURN. PROCTOR AND GAMBLE.

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL 9 WEEK STUDY OF OMAPATRILAT (BMS-186716) IN THE TREATMENT OF MILD TO MODERATE HYPERTENSION. BRISTOL-MYERS SQUIBB.

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO AND ACTIVE-CONTROLLED, PARALLEL DOSE-RANGING STUDY OF THE DUAL METALLOPROTEASE INHIBITOR, BMS-186716, IN THE TREATMENT OF MILD TO MODERATE HYPERTENSION. BRISTOL MYERS SQUIBB

A SINGLE-BLIND SAFETY AND EFFICACY STUDY COMPARING A SINGLE DOSE (1200 mg) MICONAZOLE NITRATE VAGINAL OVULE TO MONISTAT 7 VAGINAL CREAM (100 mg MICONAZOLE NITRATE) IN THE TREATMENT OF VULVOVAGINAL CANDIDIASIS (VVC) - PROTOCOL 97-006-P. ADVANCED CARE PRODUCTS.
MULTI-CENTER, PHASE III, PLACEBO CONTROLLED, DOUBLE-BLIND, BLOCK RANDOMIZED, TWO ARMED, FIVE MONTH CROSS-OVER STUDY FOLLOWED BY A ONE YEAR OPEN LABEL PHASE. GRANGEMATIC LTD.

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE EIGHTEEN

RESEARCH ACTIVITIES (CONTINUED):

A RANDOMIZED, PLACEBO CONTROLLED, PARALLEL-GROUP STUDY OF CS-866 WITH LONG-TERM SAFETY EVALUATION IN PATIENTS WITH ESSENTIAL HYPERTENSION. SANKYO.

A OPEN-LABEL EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY, TOLERABILITY AND EFFICACY OF BRL 49653C WHEN ADMINISTERED AS MONOTHERAPY, TWICE DAILY, TO PATIENTS WITH NON-INSULIN DEPENDENT DIABETES MELLITUS (NIDDM). SMITH-KLINE BEECHAM.

CLINICAL PROTOCOL FOR A MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, RANDOMIZED COMPARISON STUDY OF THE EFFICACY AND UPPER GASTROINTESTINAL SAFETY OF 100 mg, 200 mg AND 400 mg SC-58635 BID AND 500 mg NAPROXEN BID IN TREATING THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS. G. D. SEARLE AND COMPANY

CLINICAL PROTOCOL TO EVALUATE THE LONG-TERM SAFETY OF SC-5835 IN TREATING THE SIGNS AND SYMPTOMS OF OSTEOARTHRITIS, IND #48,395. G. D. SEARLE AND COMPANY.

CLINICAL PROTOCOL FOR A MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, RANDOMIZED COMPARISON STUDY OF THE EFFICACY AND UPPER GASTROINTESTINAL SAFETY OF 50 mg, 100 mg AND 200 mg SC-58635 BID AND 500 mg NAPROXEN BID IN TREATING THE SIGNS AND SYMPTOMS OF OSTEOARTHRITIS. G. D. SEARLE AND COMPANY.

A PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, PARALLEL STUDY OF THE EFFECTS OF THE NON-STEROIDAL ANTI-INFLAMMATORY DRUG INDOMETHACIN ON THE ANTIHYPERTENSIVE RESPONSE TO LOSARTAN VERSUS CAPTOPRIL IN PATIENTS WITH ESSENTIAL HYPERTENSION. MERCK.

A RANDOMIZED, DOUBLE-BIND, PLACEBO CONTROLLED SIX MONTH SAFETY AND EFFICACY TRIAL OF 7.5, 15, 30, 45 mg QD OF PIOGLITAZONE IN TYPE II DIABETES MELLITUS PATIENTS (NON-INSULIN DEPENDENT DIABETES MELLITUS, NIDDM). TAKEDA.

A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO INVESTIGATE THE SAFETY AND EFFICACY OF OMEPRAZOLE, 10 MG QD AND 20 MG QD, IN PREVENTING HEARTBURN. ASTRA MERCK.

A CLINICAL EVALUATION OF THE EFFECTS OF ESTRADIOL TD AND ETHICOMBI TD, USED SEQUENTIALLY, ON ESTRADIOL-INDUCED ENDOMETRIAL HYPERPLASIA. ETHICAL PHARMACEUTICALS (UK) LTD.

A MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED PARALLEL GROUP, PLACEBO-CONTROLLED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF AN ORAL FORMULATION OF SOY EXTRACT IN THE TREATMENT OF VASOMOTOR SYMPTOMS IN MENOPAUSAL WOMEN. ADVANCED CARE PRODUCTS

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE NINETEEN

RESEARCH ACTIVITIES (CONTINUED):

TOPICAL CILODEX (CIPROFLOXACIN 0.3%, DEXAMETHASONE 0.1%) SUSPENSION COMPARED TO CILOXAN (CIPROFLOXACIN 0.3%) SOLUTION AND CORTISPORIN SUSPENSION (NEOMYCIN 0.35%, POLYMYXIN 10,000 IU/ml, HYDROCORTISONE 1.0%) FOR PATIENTS WITH MODERATE TO SEVERE ACUTE OTITIS EXTERNA (AOE). ALCON LABORATORIES, INC.

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, SAFETY AND EFFICACY STUDY OF H 199/18 WITH AMOXICILLIN PLUS CLARITHROMYCIN COMPARED TO H 199/18 WITH CLARITHROMYCIN FOR THE ERADICATION OF HELICOBACTER PYLORI IN SUBJECTS WITH ACTIVE DUODENAL ULCER OR HISTORY OF DUODENAL ULCER DISEASE. ASTRA MERCK.

A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, FACTORIAL EFFICACY TRIAL OF COMBINATION THERAPY OF METOPROLOL SUCCINATE PLUS FELODIPINE (ONCE DAILY DOSING) IN ADULT PATIENTS WITH HYPERTENSION. SMITHKLINE.

A MULTI-CENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, GROUP-COMPARISON STUDY TO INVESTIGATE THE EFFICACY, TOLERABILITY AND SAFETY OF BAY 12-9566 AS COMPARED TO PLACEBO, IN THE TREATMENT OF PATIENTS WITH MILD TO MODERATE OSTEOARTHRITIS OF THE KNEE, OVER 3 YEARS. BAYER.

A FORTY-FIVE DAY, OPEN-LABEL STUDY OF THE SYMPTOMATIC RELIEF EFFECTS OF FLOMAX CAPSULES 0.4 mg DAILY IN PATIENTS WITH THE SIGNS AND SYMPTOMS OF BENIGN PROSTATIC HYPERPLASIA. BOEHRINGER INGELHEIM.

A MULTICENTER, DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMIZED, PARALLEL-GROUP TRIAL TO COMPARE THE EFFICACY AND SAFETY OF THREE DOSES OFMELOXICAM (3.5, 7.5, AND 15, mg) WITH PLACEBO IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE OR HIP; AND WITH DICLOFENAC (100 mg) AS AN ACTIVE CONTROL TO ASSESS TRIAL SENSITIVITY. BOEHRINGER INGELHEIM.

PLACEBO-CONTROLLED STUDY OF HIGHER DOSES OF OMAPATRILAT IN SUBJECTS WITH MILD TO MODERATE HYPERTENSION. BRISTOL MYERS SQUIBB

A PROSPECTIVE RANDOMIZED, OPEN-LABEL BLINDED-ENDPOINT (PROBE) TRIAL COMPARING MICARDIS (TELMISARTAN) (80 Mg QD) AND VALSARTAN (80mg QD) IN PATIENTS WITH MILD TO MODERATE HYPERTENSION USING AMBULATORY BLOOD PRESSURE MONITORING. BOEHRINGER INGELHEIM.

A MULTICENTER, DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMIZED, PARALLEL-GROUP TRIAL TO COMPARE THE EFFICACY AND SAFETY OF THREE DOSES OF MELOXICAM (7.5, 15, AND 22.5 mg) WITH DICLOFENAC(150 MG) AND PLACEBO IN PATIENTS WITH RHEUMATOID ARTHRITIS. BOEHRINGER INGELHEIM.

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 13-WEEK STUDY OF OMAPATRILAT (BMS-186716) IN SUBJECTS WITH ISOLATED SYSTOLIC HYPERTENSION. BRISTOL MYERS SQUIBB.

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE TWENTY

RESEARCH ACTIVITIES (CONTINUED):

SAFETY AND EFFICACY OF FIXED COMBINATION METFORMIN / GLYBURIDE PRODUCTS AS FIRST LINE THERAPY IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO HAVE INADEQUATE GLYCEMIC CONTROL WITH DIET AND EXERCISE. BRISTOL MYERS SQUIBB.

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, AMLODIPINE, AND PLACEBO-CONTROLLED, 10-WEEK STUDY OF OMAPATRILAT IN THE TREATMENT OF MILD TO MODERATE HYPERTENSION. BRISTOL MYERS SQUIBB.

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, ELECTIVE TITRATION STUDY OF OMAPATRILAT IN THE TREATMENT OF MILD TO MODERATE HYPERTENSION. BRISTOL MYERS SQUIBB.

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, LISINOPRIL AND PLACEBO-CONTROLLED TRIAL OF THE ANTIHYPERTENSIVE EFFICACY AND SAFETY OF OMAPATRILAT IN BLACK SUBJECTS WITH MILD TO MODERATE HYPERTENSION. BRISTOL MYERS SQUIBB.

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 13-WEEK STUDY OF OMAPATRILAT IN ELDERLY PATIENTS WITH MILD TO MODERATE HYPERTENSION. BRISTOL MYERS SQUIBB.

A LONG-TERM, OPEN-LABEL, MULTI-CENTER TRIAL OF THE SAFETY AND EFFICACY OF NICOSTATIN IN PATIENTS WITH DYSLIPIDEMIA. KOS PHARMACEUTICALS.

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED, COMPARATIVE THREE-ARM STUDY, EVALUATION OF THE EFFICACY AND SAFETY OF ORAL HMR 3647 800 mg ONCE A DAY FOR 5 DAYS VS. HMR 3647 800 mg ONCE A DAY FOR 10 DAYS VS. AMOXICILLIN / CLAVULANIC ACID 500/125 mg THREE TIMES A DAY FOR 10 DAYS IN THE TREATMENT OF ACUTE MAXILLARY SINUSITIS IN ADULTS. HOECHST MARION ROUSSEL, INC.

SIGNS AND SYMPTOMS, IN PATIENTS WITH STABLE, CHRONIC CONGESTIVE HEART FAILURE ( NYHA CLASS II – IV). NOVARTIS.

A RANDOMIZED STUDY OF REPAGLINIDE AND TROGLITAZONE IN TREATMENT OF TYPE 2 DIABETES IN COMBINATION INDIVIDUALLY, USING BOTH THE FIXED DOSE AND A TITRATION TO MAXIMAL EFFECT. NOVO NORDISK

A SINGLE DOSE, PLACEBO-CONTROLLED, MULTICENTER, DOSE RANGING TRIAL OF MT300 IN PATIENTS WITH ACUTE MIGRAINE HEADACHES. POZEN.

A SEVEN-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY OF PREGABALIN (150 AND 600 mg-DAY) IN PATIENTS WITH CHRONIC LOW BACK PAIN. PARKE DAVIS.

PREGABALIN OPEN-LABEL, EXTENSION SAFETY TRIAL IN PATIENTS WITH CHRONIC PAIN. PARKE DAVIS.

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE TWENTY-ONE

RESEARCH ACTIVITIES (CONTINUED):

A MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL STUDY COMPARING THE EFFICACY AND SAFETY OF TRAMADOL HYDROCHLORIDE CONTROLLED-RELEASE TABLETS VERSUS ULTRAM VERSUS PLACEBO IN PATIENTS WITH CHRONIC BACK PAIN. PURDUE PHARMA

A MULTI-CENTER, OPEN-LABEL STUDY EVALUATING THE SAFETY AND TOLERABILITY OF TRAMADOL HYDROCHLORIDE CONTROLLED-RELEASE TABLETS IN PATIENTS WITH CHRONIC PAIN. PURDUE PHARMA

A SINGLE DOSE, DOUBLE-BLIND, DOSE RANGING, PLACEBO-CONTROLLED SAFETY AND EFFICACY STUDY OF VARIOUS DOSES OF NAPROXEN SODIUM AND METOCLOPRAMIDE IN SUBJECTS WITH ACUTE MIGRAINE HEADACHES. POZEN.

A 52 WEEK, DOUBLE-BLIND, RANDOMIZED, PLACEBO CONTROLLED, MULTICENTER TRIAL TO EVALUATE THE EFFICACY OF ORLISTAT PLUS DIET IN OBESE
HYPERTENSIVE PATIENTS INADEQUATELY CONTROLLED WITH ANTIHYPERTENSIVE MEDICATIONS. ROCHE.

A DOUBLE-BLIND RANDOMIZED COMPARISON OF THE EFFICACY AND SAFETY OF 52 WEEKS OF XENICAL THERAPY PLUS DIET IN THE TREATMENT OF OBESITY IN PERI AND POST-MENOPAUSAL WOMEN AT CARDIOVASCULAR RISK. ROCHE.

EVALUATION OF THE SAFETY AND EFFECTIVENESS OF RWJ-10628 IN SUBJECTS WITH CHRONIC PAIN OF BENIGN ORGIN. R.W. JOHNSON.

RANDOMIZED, DOUBLE-BLIND, ACTIVE-AND PLACEBO-CONTROLLED, PARALLEL GROUP, DOSE RESPONSE STUDY OF THE SAFETY, PHARMACOKINETICS, AND EFFECT ON PAIN AND FUNCTION OF RWJ-57504 IN SUBJECTS WITH OSTEOARTHRITIS OF THE KNEE. R.W. JOHNSON PHARMACEUTICAL.

CLINICAL PROTOCOL FOR A MULTICENTER, DOUBLE-BLIND, PARALLEL GROUP STUDY COMPARING THE INCIDENCE OF CLINICALLY SIGNIFICANT UPPER GASTROINTESTINAL ADVERSE EVENTS ASSOCIATED WITH SC-58635 400 mg BID TO THAT OF IBUPROFEN 800 mg TID IN PATIENTS WITH OSTEOARTHRITIS OR RHEUMATOID ARTHRITIS, IND #48,395. G.D. SEARLE & COMPANY.

CLINICAL PROTOCOL TO EVALUATE THE LONG-TERM SAFETY OF SC-58635 IN TREATING THE SIGNS AND SYMPTOMS OF OSTEOARTHRITIS AND RHEUMATOID ARTHRITIS. G.D. SEARLE & COMPANY.

A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED COMPARISON STUDY OF THE EFFICACY AND UPPER GI SAFETY OF TWO DOSES OF SC-58635 BID AND NEPROXEN 500 mg BID IN TREATING THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS. G.D. SEARLE & COMPANY.
LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE TWENTY-TWO

RESEARCH ACTIVITIES (CONTINUED):

AN OPEN-LABEL EXTENSION STUDY TO ACCESS THE LONG-TERM SAFETY, TOLERABILITY AND EFFICACY OF BRL49653C WHEN ADMINISTERED ONCE OR TWICE DAILY IN COMBINATION WITH METFORMIN TO PATIENTS WITH NON-INSULIN DEPENDENT DIABETES MELLITUS (NIDDM). SMITH KLINE.

A 13-WEEK, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL, MULTICENTER STUDY OF TEVETEN GIVEN IN TITRATED DOSES OF 600 mg OR 1200 mg ONCE DAILY, IN PATIENTS WITH ISOLATED SCHOLASTIC HYPERTENSION (SITSBP>160mmHg AND SITDBP<90mmHg). SMITH KLINE.

LINEZOLID VS. CLARITHROMYCIN FOR THE TREATMENT UNCOMPLICATED SKIN AND SUPERFICIAL SKIN STRUCTURE INFECTIONS. PHARMACIA & UPJOHN.

AN OPEN LABEL, LONG-TERM EXTENSION STUDY OF PIOGLITAZONE (AD-4833) IN TYPE II DIABETES MELLITUS PATIENTS (NON-INSULIN DEPENDENT DIABETES MELLITUS, NIDDM). TAKEDA.

STUDY TO EVALUATE THE EFFECTS OF EM574 5 mg QID, 10 mg TID, 20 mg BID VERSUS PLACEBO IN FEMALES WITH NON-EROSIVE GASTROESOPHAGEAL REFLUX DISEASE. TAP.

COMPARATIVE SAFETY AND EFFICACY OF CEFDITOREN PIVOXIL AND AUGMENTIN (AMOXICILLIN / CLAVULANATE POTASSIUM) IN THE TREATMENT OF PATIENTS WITH ACUTE MAXILLARY SINUSITIS. TAP.

A DOUBLE BLIND, RANDOMIZED, PLACEBO CONTROLLED TRIAL OF PLECONARIL IN THE TREATMENT OF PICORNAVIRUS RESPIRATORY TRACT DISEASE (VIRAL SYNDROME CAUSED BY PICORNAVIRUS). VIROPHARMA.

AN OPEN-LABEL, LONG TERM SAFETY EXTENSION STUDY OF SUSTAINED RELEASE DEXFENFLURAMINE IN OBESE OUTPATIENTS. WYETH-AYERST RESEARCH.

AN ECHOCARDIOGRAPHIC FOLLOW-UP STUDY OF SUBJECTS WHO PARTICIPATED IN THE WYETH-AYERST RESEARCH PROTOCOL 0927B1-300-US.

AN ECHOCARDIOGRAPHIC EVALUATION OF PATIENTS EXPOSED TO ANOREXIGENS AS COMPARED TO UNEXPOSED MATCHED CONTROLS. WYETH-AYERST RESEARCH

A RANDOMIZED, PLACEBO CONTROLLED, PARALLEL GROUP, DOUBLE BLIND STUDY TO EVALUATE THE EFFICACY AND SAFETY OF MK-0966 12.5 mg VS. NABUMETONE 1000 mg IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE. MERCK.

A MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED STUDY TO DETERMINE THE EFFICACY AND SAFETY OF TWO DOSE LEVELS OF SR90067u, A TRANSDERMAL ESTRADIOL SPRAY IN POST-MENOPAUSAL WOMEN WITH VASOMOTOR SYMPTOMS. SANOFI.

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE TWENTY-THREE

RESEARCH ACTIVITIES (CONTINUED):

DOUBLE-BLIND, PLACEBO CONTROLLED COMPARISON OF THE EFFICACY AND SAFETY OF PROPRIAM, TRAMADOL (ULTRAM), AND PLACEBO WITH AN OPEN-LABEL EXTENSION IN THE TREATMENT OF PAIN ASSOCIATED WITH OSTEOARTHRITIS OF THE KNEE AND /OR HIP. ROBERTS PHARMACEUTICALS.

A PROSPECTIVE, MULTINATIONAL, MULTICENTER, DOUBLE-BLIND, RANDOMIZED, ACTIVE-CONTROLLED TRIAL IN PATIENTS WITH ESSENTIAL HYPERTENSION TO COMPARE THE EFFECT OF VALSARTAN 80 AND 160 mg, WITH OR WITHOUT THE ADDITION OF HYDROCHLOROTHIAZIDE, ONCE DAILY TO THAT OF AMLODIPINE 5 AND 10 mg ONCE DAILY, WITH OR WITHOUT THE ADDITION OF HYDROCHLOROTHIAZIDE, ON CARDIOVASCULAR MORBIDITY AND MORTALITY. NOVARTIS.

AN OPEN LABEL, LONG-TERM TOLERABILITY STUDY OF PIOGLITAZONE (AD-4833) IN TYPE II DIABETES MELLITUS PATIENTS (NON-INSULIN DEPENDENT DIABETES MELLITUS, NIDDM). TAKEDA.

A TRIPLE-BLIND, RANDOMIZED, PARALLEL, EFFICACY STUDY OF LOSARTAN VERSUS IRBESARTAN IN PATIENTS WITH MILD TO MODERATE HYPERTENSION. MERCK.

A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY COMPARISON OF GLYBURIDE
20 mg/DAY WITH A TITRATED DOSE OF V20001 IN TYPE II DIABETIC PATIENTS. PURDUE PHARMA

A PHASE II DOUBLE BLIND DOSE RESPONSE INVESTIGATION OF THE EFFICACY AND SAFETY OF FOUR DOSES OF SCH58235 COMPARED TO PLACEBO IN SUBJECTS WITH PRIMARY HYPERCHOLESTEROLEMIA. SCHERING-PLOUGH.

A ONE YEAR RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF ALOSETRON (GR68755) 1 mg BID IN FEMALE SUBJECTS WITH IRRITABLE BOWEL SYNDROME (IBS). GLAXOWELLCOME.

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, TWO-YEAR PARALLEL GROUP STUDY OF THE EFFICACY AND SAFETY OF GI198745 0.5MG IN THE TREATMENT AND PREVENTION OF PROGRESSION OF BENIGN PROSTATIC HYPERPLASIA. GLAXO WELLCOME

A COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF CLARITHROMYCIN IMMEDIATE RELEASE TABLETS AND LORACARBEF PULVULES FOR THE TREATMENT OF PATIENTS WITH SECONDARY BACTERIAL INFECTION OF ACUTE BRONCHITIS. ABBOTT LABORATORIES.

A SINGLE-BLIND SAFETY AND EFFICACY STUDY COMPARING A SINGLE DOSE OF MICONZOLE NITRATE 600 MG (12%) VAGINAL CREAM TO MONISTAT 7 VAGINAL CREAM (100 MG MOCONAZOLE NITRATE) IN THE TREATMENT OF VULVOVAGINAL CANDIDIASIS (vvc). ADVANCED CARE PRODUCTS.

A DOUBLE-BLIND, RANDOMIZED, PARALLEL EFFECTIVENESS STUDY OF TWO HYPERTENSIVE TREATMENT REGIMENS; LOSARTAN VERSUS VALSARTAN IN PATIENTS WITH MILD TO MODERATE ESSENTIAL HYPERTENSION. MERCK & CO., INC.
LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE TWENTY-FOUR

RESEARCH ACTIVITIES (CONTINUED):

A DOUBLE-BLIND, RANDOMIZED, PARALLEL-GROUP, MULTIPLE-DOSE STUDY TO COMPARE THE EFFICACY OF FAMOTIDINE/ANTACID COMBINATION, FAMOTIDINE 10MG, ANTACID, AND PLACEBO IN PATIENTS WITH FREQUENT HEARTBURN (NO.2). MERCK & CO., INC.

A STUDY TO EVALUATE THE EFFECT OF LANSOPRAZOLE 30MG QD VERSUS OMEPRAZOLE 20MG QD ON RELIEF OF SYMPTOMS IN PATIENTS WITH EROSIVE REFLUX ESOPHAGITIS. TAP.

A SINGLE DOSE, PLACEBO-CONTROLLED, DOSE RANGING TRIAL OF MT 300 IN PATIENTS WITH ACUTE MIGRAINE HEADACHES. POZEN, INC.

A COMPARATIVE STUDY OF LOVASTATIN XL WITH MEVACOR IN PATIENTS WITH HYPERCHOLESTEROLEMIA. HEALTH RESEARCH MANAGEMENT.

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, SINGLE-ATTACK EVALUATION OF SUMATRIPTAN 50mg AND 100mg VERSUS PLACEBO DURING A MIGRAINE HEADACHE AT THE FIRST SIGN OF PAIN. GLAXO WELLCOME.

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO ASSESS THE EFFICACY AND SAFETY OF GI262570 SODIUM TABLETS (2.5mg, 5mg, AND 7.5mg) ADMINISTERED AS A DAILY DOSE FOR 8 WEEKS IN SUBJECTS WITH DYSLIPIDEMIA. GLAXO WELLCOME.

AN OPEN-LABEL EVALUATION OF THE LONG-TERM SAFETY OF ORAL NARATRIPTAN 1mg TWICE DAILY AS SHORT-TERM PROPHYLACTIC TREATMENT FOR MENSTRUALLY-ASSOCIATED MIGRAINE. GLAXO WELLCOME.

A 6 MONTH MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PILOT STUDY TO INVESTIGATE THE TOLERABILITY AND EFFICACY OF BUPROPION SR COMPARED TO PLACEBO FOR THE TREATMENT OF MILD DEPRESSIVE SYMPTOMS AND OBESITY. GLAXO WELLCOME.

REPAGLINIDE VS. ROSIGLITAZONE VS. THE COMBINATION IN TYPE 2 DIABETES PATIENTS: A 24-WEEK, RANDOMIZED, CONTROLLED MULTICENTER TRIAL. NOVO NORDISK.

A PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, PARALLEL EFFICACY STUDY OF A LOSARTAN TREATMENT REGIMEN VERSUS PLACEBO IN THE TREATMENT OF PATIENTS WITH ISOLATED SYSTOLIC HYPERTENSION. MERCK & CO., INC.

A MULTICENTER, CONTROLLED EVALUATION OF THE EFFICACY AND SAFETY OF REPEATED ORAL DOSES OF VICOPROFENâ (HYDROCODONE BITARTRATE WITH IBUPROFEN) VS. OXYCODONE HCI WITH ACETAMINOPHEN, IN PATIENTS WITH ACUTE LOW BACK PAIN. KNOLL PHARMACEUTICALS.

A THREE YEAR, OPEN LABEL, ANALGESIC EFFICACY, SAFETY, ACCEPTABILITY AND QUALITY OF LIFE REGISTRY OF CONTROLLED RELEASE OXYCODONE TABLETS (OXYCONTINâ) IN CHRONIC NON-CANCER PAIN. PURDUE PHARMA.

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE TWENTY-FIVE

RESEARCH ACTIVITIES (CONTINUED):

A COMPARISON OF THE ANALGESIC EFFICACY AND SAFETY OF TRAMADOL HCI/ACETAMINOPHEN VERSUS PLACEBO FOR THE TREATMENT OF THE SIGNS AND SYMPTOMS OF OSTEOARTHRITIS IN SUBJECTS RECEIVING A COX-2 SELECTIVE INHIBITOR. ORTHO-McNeil PHARMACEUTICAL

A COMPARISON OF THE ANALGESIC EFFICACY OF TRAMADOL HCL/ACETAMINOPHEN VERSUS PLACEBO FOR THE TREATMENT OF CHRONIC LOWER BACK PAIN. ORTHO-McNEIL PHARMACEUTICAL.

A RANDOMIZED, OPEN-LABEL, COMPARATIVE, MULTI-CENTER TRIAL TO EVALUATE CONTRACEPTIVE EFFICACY, CYCLE CONTROL, SAFETY AND ACCEPTABILITY OF A MONOPHASIC COC CONTAINING 200ug ORG 30659 AND 20ug EE, COMPARED TO A COC CONTAINING 100ug LEVONORGESTREL AND 20ug EE. ORGANON.

A DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP COMPARISON STUDY OF THE SAFETY OF CELECOXIB VS ROFECOXIB IN HYPERTENSIVE PATIENTS WITH PERIPHERAL OSTEOARTHRITIS TAKING ANTIHYPERTENSIVE MEDICATIONS. SEARLE & CO., INC.

A DOUBLE-BLIND, RANDOMIZED, ACTIVE-CONTROLLED COMPARISON STUDY OF THE ANTIHYPERTENSIVE, RENAL, AND METABOLIC EFFECTS OF EPLERENONE VERSUS ENALAPRIL IN PATIENTS WITH TYPE 2 DIABETES MELLITUS, ALBUMINURIA, AND HYPERTENSION. SEARLE & CO., INC.

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF RWJ-270201 IN THE TREATMENT OF ACUTE INFLUENZA A AND B INFECTION IN HEALTHY ADULTS. R.W. JOHNSON.

RANDOMIZED, MULTI-CENTER, MULTI-DOSE, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GROUP STUDY COMPARING THE EFFICACY AND SAFETY OF SUSTAINED-RELEASE OXYCODONE (OXYCODONE SR) TO PLACEBO IN THE TREATMENT OF PAIN ASSOCIATED WITH OSTEOARTHRITIS. ROXANE LABORATORIES.

THE SAFETY AND EFFICACY OF PNU-182716 VERSUS ROSIGLITAZONE: A ONE-YEAR, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, ACTIVE COMPARATOR STUDY. PHARMACIA & UPJOHN.

A RANDOMIZED, PLACEBO-CONTROLLED, FACTORIAL DESIGN STUDY OF CS-866 AND HYDROCHLOROTHIAZIDE IN PATIENTS WITH ESSENTIAL HYPERTENSION. SANKYO.

A LONG TERM, OPEN-LABEL STUDY OF CS-866 AND HYDROCHLOROTHIAZIDE IN PATIENTS WITH ESSENTIAL HYPERTENSION. SANKYO.

AN EXTENDED SAFETY, EFFICACY AND TOLERABILITY STUDY OF LOVASTATIN XL IN PATIENTS WITH HYPERCHOLESTEROLEMIA. HEALTH RESEARCH MANAGEMENT.

PHASE II, DOSE-RESPONSE STUDY OF ORAL NO-1886 IN SUBJECTS WITH MARKED HYPERTRIGLYCERIDEMIA. TAP HOLDINGS, INC.

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE TWENTY-SIX

RESEARCH ACTIVITIES (CONTINUED):

COMPARATIVE STUDY OF COVERA-HSâ (COER-VERAPAMIL) VS AN ACE INHIBITOR (ENALAPRIL), AN ANGIOTENSIN II RECEPTOR BLOCKER (LOSARTAN), AND PLACEBO IN PATIENTS WITH STAGE I-II ESSENTIAL HYPERTENSION. SEARLE & CO., INC.

CLINICAL PROTOCOL TO EVALUATE THE EFFECTS OF TWICE DAILY CELECOXIB VERSUS PLACEBO ON BLOOD PRESSURE IN HYPERTENSIVE PATIENTS WHOSE BLOOD PRESSURE IS CONTROLLED WITH THE ANGIOTENSIN – CONVERTING ENZYME INHIBITOR LISINOPRIL. SEARLE & CO., INC.

CLINICAL PROTOCOL FOR A LONG-TERM, OPEN-LABEL STUDY OF THE SAFETY AND EFFICACY OF EPLERENONE. SEARLE & CO., INC

A RANDOMIZED MULTICENTER, DOUBLE-BLIND, DOUBLE-DUMMY TRIAL COMPARING AZITHROMYCIN 500mg DAILY FOR 3 DAYS WITH CLARITHROMYCIN 1 GRAM DAILY FOR 10 DAYS FOR THE TREATMENT OF ACUTE BACTERIAL EXACERBATION OF CHRONIC BRONCHITIS. PFIZER.

A TRIAL TO INVESTIGATE THE COMPARATIVE EFFICACY AND SAFETY OF NISOLDIPINE AND AMLODIPINE FOR THE TREATMENT OF BLACK SUBJECTS WITH HYPERTENSION. ZENECA PHARMACEUTICALS.

AN OPEN-LABEL, MULTINATIONAL, MULTICENTRE, EXTENSION TRIAL TO ASSESS THE LONG-TERM SAFETY AND EFFICACY OF ZD4522 IN SUBJECTS IN THE ZD4522 CLINICAL TRIAL PROGRAM. ZENECA PHARMACEUTICALS.

A 12-WEEK RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED MULTICENTER TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF ZD4522 (5 AND 10 mg) AND ATORVASTATIN (10mg) IN THE TREATMENT OF SUBJECTS WITH HYPERCHOLESTEROLEMIA. ZENECA PHARMACEUTICALS.

A 6-WEEK RANDOMIZED DOUBLE-BLIND MULTICENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ZD4522 (5, 10, 20, 40, AND 80 mg) AND ATORVASTATIN (10, 20, 40, AND 80 mg) ACROSS THEIR RESPECTIVE DOSE RANGES IN THE TREATMENT OF SUBJECTS WITH HYPERCHOLESTEROLEMIA. ZENECA PHARMACEUTICALS.

A PLACEBO-CONTROLLED, DOUBLE-BLIND, RANDOMIZED TRIAL OF A TABLET FORMULATION OF PLECONARIL IN THE TREATMENT OF VIRAL RESPIRATORY INFECTION IN ADULTS. VIROPHARMA, INC.

A STUDY TO DETERMINE THE EFFECTIVENESS AND SAFETY OF TOPICALLY APPLIED EST 321 VERSUS VEHICLE PATIENTS WITH DECREASED ACTIVE RANGE OF MOTION ASSOCIATED WITH IMPAIRED SHOULDER FUNCTION. ENTROPIN, INC.

EVALUATION OF THE EFFICACY OF PHENZOPYRIDINE HYDROCHLORIDE (FORMULA PD-F-0016) AS A URINARY ANALGESIC IN WOMEN WITH URINARY TRACT INFECTIONS. ADVANCED CARE PRODUCTS.

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE TWENTY-SEVEN

RESEARCH ACTIVITIES (CONTINUED):

A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, TITRATION-TO-RESPONSE TRIAL COMPARING MICARDISâ (TELMISARTAN) (40 & 80 mg QD) AND COZAARâ (LOSARTAN) (50 & 100 mg QD) IN PATIENTS WITH MILD-TO-MODERATE HYPERTENSION USING AMBULATORY BLOOD PRESSURE MONITORING. BOEHRINGER INGELHEIM.

A DOUBLE-BLIND COMPARISON OF 10, 20, 40, AND 80 mg DOSES OF A MODIFIED-RELEASE FORMULATION OF PRAVASTATIN, OF ATORVASTATIN 10 mg, AND OF SIMVASTATIN 20 mg WITH PLACEBO IN HYPERCHOLESTEROLEMIC SUBJECTS. BRISTOL-MYERS SQUIBB.

A RANDOMIZED, DOUBLE-BLIND STUDY OF THE ANTIHYPERTENSIVE EFFICACY AND SAFETY OF COMPARED TO LOSARTAN. BRISTOL-MYERS SQUIBB.

A DOUBLE-BLIND, PLACEBO-CONTROLLED DOSE TITRATION STUDY OF THE SAFETY AND EFFICACY OF DILACOR XR IN ELDERLY PATIENTS WITH MILD TO MODERATE HYPERTENSION. RHONE-POULENC RORER.

A DOUBLE-BLIND, PARALLEL MULTI-CENTER STUDY TO DETERMINE THE EFFICACY AND SAFETY OF Q.I.D. TOPICAL PIROXICAM FEL COMPARED WITH PLACEBO IN ACUTE LATERAL EPICONDYLITIS. PFIZER.

EFFICACY AND TOLERABILITY OF EXTENDED-RELEASE FELODIPINE IN ADULT PATIENTS WITH MILD TO MODERATE UNCOMPLICATED ESSENTIAL HYPERTENSION. MERCK.

A PARALLEL, DOUBLE-BLIND, RANDOMIZED, SINGLE-DOSE STUDY COMPARING THE ANALGESIC EFFICACY AND SAFETY OF ACETAMINOPHEN 1000 mg, NAPROXEN 375 mg, AND PLACEBO IN THE TREATMENT OF TENSION HEADACHE. McNEIL.

A RANDOMIZED, DOUBLE-BLIND, COMPARATIVE MULTIFACTORIAL DOSE-RESPONSE STUDY COMPARING THE EFFICACY AND SAFETY OF BISOPROLOL, CILAZAPRIL AND THE BISOPROLOL/CILAZAPRIL COMBINATION, TO PLACEBO, GIVEN ONCE DAILY IN OUTPATIENTS WITH MILD-TO-MODERATE ESSENTIAL HYPERTENSION. EM INDUSTRIES.

DOUBLE-BLIND, RANDOMIZED TRIAL COMPARING FOSINOPRIL VERSUS ENALAPRIL IN MILD-TO-MODERATE ESSENTIAL HYPERTENSIVE PATIENTS WITH A HISTORY OF ACE INHIBITOR-ASSOCIATED COUGH. BRISTOL-MYERS SQUIBB.

EFFICACY AND SAFETY EVALUATION OF GITS VERAPAMIL 240 mg ONCE DAILY VERSUS PLACEBO IN THE TREATMENT OF MILD TO MODERATE HYPERTENSION. LOREX PHARMACEUTICALS.

DOUBLE-BLIND, RANDOMIZED TRIALS COMPARING ONCE DAILY FOSINOPRIL SODIUM VERSUS NIFEDIPINE FITS IN OLDER PATIENTS WITH MILD-TO-MODERATE ESSENTIAL HYPERTENSION WITH THE ADDITION OF LOW-DOSE HCTZ FOR NON-RESPONDERS. BRISTOL-MYERS SQUIBB.

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE TWENTY-EIGHT

RESEARCH ACTIVITIES (CONTINUED):

LONG TERM SURVEILLANCE STUDY OF ZILEUTON PLUS USUAL CARE VERSUS USUAL CARE IN PATIENTS WITH ASTHMA. ABBOTT.

A MULTICENTER, OUTPATIENT, RANDOMIZED DOUBLE-BLIND, PARALLEL EVALUATION OF THE ANALGESIC EFFICACY AND SAFETY OF MULTIPLE ORAL DOSES OF ULTRAMâ TRAMADOL HYDROCHLORIDE 50 mg (UP TO 400 mg DAILY) COMPARED TO ACETAMINOPHEN 300 mg WITH CODEINE 30 mg (UP TO 8 CAPSULES DAILY) IN AMBULATORY SUBJECTS WITH ACUTE MUSCULOSKELETAL PAIN (I.E., SPRAINS, STRAINS, AD FRACTURES). ORTHO-McNEIL.

A DOUBLE-BLIND, RANDOMIZED PARALLEL GROUP COMPARATIVE STUDY OF THE EFFICACY OF NIFEDIPINE COAT-CORE (30mg AND 60mg DAILY) VERSUS NIFEDIPINE GITS (30mg AND 60mg DAILY) ADMINISTERED WITHOUT FOOD IN PATIENTS WITH MILD TO MODERATE HYPERTENSION. MILES PHARMACEUTICALS.

A RANDOMIZED, DOUBLE-BLIND, MULTICENTER TRIAL COMPARING 7 DAYS OF ORAL THERAPY WITH CP-99,219 (100 mg OR 200 mg DAILY) OR CIPROFLOXACIN HYDROCHLORIDE (500 mg DAILY) FOR THE TREATMENT OF UNCOMPLICATED URINARY TRACT INFECTIONS. PFIZER.

A PLACEBO CONTROLLED, RANDOMIZED, AGE-STRATIFIED, MULTICENTER STUDY OF THE SAFETY, TOLERABILITY, AND EFFECTIVENESS OF ESTRACE IN THE TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN 55 YEARS OF AGE AND OLDER. BRISTOL-MYERS SQUIBB.

A DOUBLE-BLIND RANDOMIZED, PLACEBO-CONTROLLED MULTICENTER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF INHALED AND INTRANASAL GG167 IN THE TREATMENT OF INFLUENZA A AND B VIRAL INFECTION. GLAXO.

A DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, PARALLEL-GROUP STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF GG167 IN THE PREVENTION AND/OR PROGRESSION OF INFLUENZA A AND B VIRAL INFECTIONS. GLAXO WELLCOME.

MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL 9-WEEK DOSE-RANGING STUDY OF OMAPATRILAT IN THE TREATMENT OF MILD TO MODERATE HYPERTENSION. BRISTOL-MYERS SQUIBB.

A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ROSIGLITAZONE ADDED ON TO A BACKGROUND OF METFORMIN/GLYBURIDE TABLETS IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS WHO HAVE INADEQUATE GLYCEMIC CONTROL ON METFORMIN/GLYBURIDE THERAPY. BRISTOL-MYERS SQUIBB.

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP TRIAL COMPARING THE SAFETY AND EFFICACY OF METFORMIN/GLYBURIDE TO PIOGLITAZONE AS FIRST LINE THERAPY IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO HAVE INADEQUATE GLYCEMIC CONTROL WITH DIET AND EXERCISE. BRISTOL-MYERS SQUIBB.
LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE TWENTY-NINE

RESEARCH ACTIVITIES (CONTINUED):

A MULTI-CENTER, RANDOMIZED, PARALLEL-GROUP, OPEN-LABEL STUDY TO COMPARE PRESCRIPTION NON-STEROIDAL ANTI-INFLAMMATORY DRUG (NSAID) CHANGES, HEALTH CARE UTILIZATION, EFFICACY AND SAFETY OF MELOXICAM 7.5 mg VERSUS USUAL CARE ADMINISTRATION OF PRESCRIPTION NSAIDS IN A MANAGED HEALTHCARE SETTING IN PATIENTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE. BOEHRINGER INGELHEIM.

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER, FIXED-DOSE, PARALLEL GROUP, 6-MONTH COMPARISON STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF THE PHOSPHODIESTERASE TYPEV INHIBITOR BAY 38-9456 IN MALES WITH ERECTILE DYSFUNCTION. BAYER CORP.

A CLINICAL EVALUATION OF THE EFFECTS OF ESTRADIOL TD AND ETHICOMBI, USED SEQUENTIALLY ON ESTRADIOL-INDUCED ENDOMETRIAL HYPERPLASIA. KENDLE.

A DOUBLE BLIND PILOT STUDY TO EVALUATE THE SAFETY AND EFFICACY OF CELECOXIB, ACETAMINOPHEN, AND MK-0966 IN PATIENTS WITH OSTEOARTHIRITIS OF THE KNEE. MERCK & CO.

A RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP, DOUBLE-BLIND STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ROFECOXIB 25 mg AND CELECOXIB 200 mg IN PATIENTS WITH OSTEOARTHIRITIS OF THE KNEE OR HIP. MERCK & CO.

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE RESPONSE STUDY. SMITH KLINE BEECHAM.

CLINICAL PROTOCOL FOR A DOUBLE-BLIND, MULTICENTER, PLACEBO-CONTROLLED, STUDY TO EVALUATE THE EFFICACY AND SAFETY OF SC-58635 25 mg, 100mg, AND 400mg BID VERSUS PLACEBO IN TREATING THE SIGNS AND SYMPTOMS OF OSTEOARTHRITIS OF THE KNEE. SEARLE.

CLINICAL PROTOCOL FOR A MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED COMPARISON STUDY OF THE EFFICACY OF SC-58635 200mg QD VERSUS SC-58635 100mg BID IN TREATING THE SIGNS AND SYMPTOMS OF OSTEOARTHIRITIS OF THE KNEE. SEARLE.

A USUAL USE, OPEN-LABEL, RANDOMIZED, 3 MONTH COHORT, OUTCOMES STUDY IN PERSISTENT BACK PAIN COMPARING OXYCONTINâ Q12H (CONTROLLED RELEASE OXYCODONE) VS. HYDROCORODONE/APAP Q4-6 PRN. PURDUE PHARMA L.P,

A COMPARATIVE STUDY OF THE SAFETY AND EFFICACY OF CALCIUM MUPIROCIN CREAM WITH CEPHALEXIN IN THE TREATMENT OF SECONDARILY INFECTED OPEN WOUNDS, A RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY MULTI-CENTER COMPARATIVE STUDY. SMITHKLINE BEECHAM.

A 26-WEEK RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP STUDY TO COMPARE THE EFFICACY, SAFETY AND TOLERABILITY OF ROSIGLITAZONE (2mg BID AND 4mg BID) VERSUS PLACEBO IN COMBINATION WITH GLYBURIDE AND METFORMIN IN PATIENTS WITH TYPE 2 DIABETES MELLITUS. SMITHKLINE BEECHAM.
LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE THIRTY

RESEARCH ACTIVITIES (CONTINUED):

AN OPEN-LABEL, REPEAT DOSE, LONG-TERM SAFETY OF MT100 IN SUBJECTS WITH ACUTE MIGRAINE ATTACKS. POZEN.

PHASE III STUDY OF THE SAFETY AND EFFICACY OF ABT-761 150mg, 300mg QD VERSUS PLACEBO IN MODERATE ASTHMA. ABBOTT LABORATORIES.

OPEN EVALUATION OF THE LONG-TERM EFFICACY, SAFETY AND TOLERABILITY OF 1.4mg SC ALNIDITAN IN THE ACUTE TREATMENT OF MIGRAINE ATTACKS. JANSSEN PHARMACEUTICALS.

TO EXPLORE THE EFFICACY OF PRILOSEC DOSING REGIMEN (OMEPRAZOLE 20 mg + 8 oz OF WATER) VERSUS A PLACEBO, IN FIRST-DOSE RELIEF OF HEARTBURN. OKLAHOMA FOUNDATION FOR DIGESTIVE RESEARCH.

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND TRIAL OF THE ANTIHYPERTENSIVE EFFICACY AND SAFETY OF IRBESARTAN IN ELDERLY SUBJECTS WITH MILD-TO-MODERATE HYPERTENSION. BRISTOL-MYERS SQUIBB.

A RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF ALNIDITAN (0.4, 0.8 OR 1.4mg) GIVEN SUBCUTANEOUSLY IN THE ACUTE TREATMENT OF MIGRAINE. JANSSEN PHARMACEUTICALS.

A RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PHASE II/III COMPARISON OF TWO DOSE REGIMENS OF GATIFLOXACIN TO CIPROFLOXACIN IN THE TREATMENT OF WOMEN WITH ACUTE, UNCOMPLICATED URINARY TRACT INFECTION. BRISTOL-MYERS SQUIBB.

A RANDOMIZED, DOUBLE-BLIND, EXPLORATORY, COMPARISON OF TITRATED DOSES OF V20001 AND GLYBURIDE IN TYPE 2 DIABETIC PATIENTS. PURDUE PHARMA L.P.

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, COMPARATIVE STUDY OF CS-866 AND AMLODIPINE USING ABPM IN PATIENTS WITH ESSENTIAL HYPERTENSION. SANKYO.

A RANDOMIZED, DOUBLE-BLIND STUDY OF THE ANTIHYPERTENSIVE EFFICACY AND SAFETY OF OMAPATRILAT COMPARED TO LOSARTAN. BRISTOL MYERS SQUIBB.

RANDOMIZED, DOUBLE-BLIND, MULTICENTER PILOT TRIAL OF ONCE DAILY ECADOTRIL (400MG, 600MG, AND 800MG) VS. PLACEBO IN ESSENTIAL HYPERTENSION. MILES PHARMACEUTICALS.

A RANDOMIZED, DOUBLE-BLINDED PHARMAECONOMIC EVALUATION OF AZMACORTâ (TRIAMCINOLONE ACETONIDE). RHONE-POULEC RORER.

A DOUBLE-BLIND, RANDOMIZED, MULTICENTER STUDY TO COMPARE THE SAFETY OF DEXIBUPROFEN LYSINE WITH IBUPROFEN FOR LONG-TERM TREATMENT OF OSTEOARTHRITIS. MERCK & CO.

RELIEF OF EPISODIC HEARTBURN: SAFETY AND EFFICACY OF NIZATIDINE 75 MG – A PLACEBO-CONTROLLED STUDY. WHITEHALL-ROBINS HEALTHCARE.
LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE THIRTY-ONE

RESEARCH ACTIVITIES (CONTINUED):

A DOUBLE-BLIND, MULTICENTER TRIAL COMPARING ORAL THERAPY WITH CP-99,219 (100MG DAILY) AND ORAL CEFPODOXIME PROXETIL VANTINÔ (400 MG BID) FOR THE TREATMENT OF UNCOMPLICATED INFECTIONS OF THE SKIN AND SKIN STRUCTURE. PFIZER.

A COMPARATIVE STUDY OF THE EFFICACY AND SAFETY OF CLARITHROMYCIN EXTENDED RELEASE TABLETS AND SUPRAXâ TABLETS FOR THE TREATMENT OF PATIENTS WITH ACUTE BRONCHITIS. ABBOTT LABORATORIES.

MULTICENTER DOUBLE-BLIND, PLACEBO CONTROLLED, RANDOMIZED COMPARISON STUDY OF THE EFFICACY AND UPPER GASTROINTESTINAL SAFETY OF 100 MG, 200 MG ND 400 MG SC-58635 BID AND 500 MG NAPROXEN BID IN TREATING THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS. SEARLE.

A CLINICAL EVALUATION OF THE EFFECTS F ESTRADIOL TD AND ETHICOMBI TD, USED SEQUENTIALLY, ON ESTRADIOL-INDUCED ENDOMETRIAL HYPERPLASIA. KENDLE.

MULTICENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL GROUP, STUDY COMPARING THE INCIDENCE OF GASTRODUODENAL ULCER WITH VALDECOXIB 10 MG AND VALDECOXIB 20MG QD TO THAT OF IBUPROFEN 800 MG TID AND DICLOFENAC SODIUM 75 MG BID IN PATIENTS WITH OSTEOARTHRITIS. SEARLE.

A 26-WEEK RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP STUDY TO COMPARE THE EFFICACY, SAFETY AND TOLERABILITY OF ROSIGLITAZONE (2MG BID AND 4 MG BID) VERSUS PLACEBO IN COMBINATION WITH GLYBURIDE AND METFORMIN IN PATIENTS WITH TYPE 2 DIABETES MELLITUS. SMITHKLINE BEECHAM.

CELECOXIB SAFETY VS ROFECOXIB IN MEDICATION TREATED HYPERTENSIVE PATIENTS WITH PERIPHERAL OA. SEARLE.

A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL-GROUP, FORCED-TITRATION STUDY. ASTRA PHARMACEUTICALS.

A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED STUDY TO EVALUATE THE SAFETY AND EFFICACY OF RANGING DOSES OF EPLERENONE RELATIVE TO PLACEBO, HYDROCHLOROTHIAZIDE AND DAILY DOSE COMBINATIONS OF EPLERENONE AND HYDROCHLOROTHIAZIDE FOR THE TREATMENT OF MILD TO MODERATE HYPERTENSION. SEARLE.

A RANDOMIZED, DOUBLE BLIND, PARALLEL GROUP EVALUATION OF CERVISTATIN 0.8 MG, COMPARED TO CERVISTATIN 0.4 MG, AND PLACEBO/PRAVASTATIN 20 MG, ONCE DAILY IN PATIENTS WITH HYPERCHOLESTEROLEMIA. BAYER.

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE THIRTY-TWO

RESEARCH ACTIVITIES (CONTINUED):

A RANDOMIZED, PARALLEL GROUP, DOUBLE-BLIND, 12 MONTH, DOSE-RANGING, MULTI-CENTER STUDY PROTOCOL TO DETERMINE THE LOWEST EFFECTIVE CONTINUOUS AND

SEQUENTIAL TRANSDERMAL NETA DOSE REQUIRED TO PREVENT ESTROGEN-INDUCED ENDOMETRIAL HYPERPLASIA. PROCTOR AND GAMBLE.

A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED TRIAL OF THE EFFECT OF WEEKLY AZITHROMYCIN ON THE INCIDENCE OF CORONARY ARTERY DISEASE IN SUBJECTS WITH EVIDENCE OF EXPOSURE TO C. PNEUMONIAE. PFIZER.

A RANDOMIZED, DOUBLE-BLINDED, PLACEBO-CONTROLLED, MULTI-CENTER, LONG-TERM EFFICACY STUDY TRIAL OF PREVENTING HYPERTENSION USING CANDESARTAN CILEXTIL 16MG IN PATIENTS WITH BORDERLINE HYPERTENSION HIGH NORMAL BLOOD PRESSURE. ASTRA.

A RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, COMPARATIVE STUDY OF CS-866, LOSARTAN, VALSARTAN AND IRBESARTAN USING AMBULATORY BLOOD PRESSURE MONITORING IN PATIENTS WITH ESSENTIAL HYPERTENSION. SANKYO.

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, FORCED-TITRATION, MULTICENTER TRIAL COMPARING THE SAFETY AND EFFICACY OF ORAL DIOVAN (80/160 MG) ONCE DAILY TO PLACEBO IN ELDERLY SUBJECTS WITH HYPERTENSION. NOVARTIS.

PHASE II DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL, 4 WEEK EVALUATION OF THE EFFICACY AND SAFETY OF MULTIPLE DOSES OF CJ-13,974 IN SUBJECTS WITH MODERATE TO SEVERE CHRONIC BACK PAIN. PFIZER.

A RANDOMIZED, OPEN-LABEL, COMPARATIVE, MULTI-CENTER TRIAL TO EVALUATE CONTRACEPTIVE EFFICACY, CYCLE CONTROL, SAFETY AND ACCEPTABILITY OF A MONOPHASIC COC CONTAINING 200 MG ORGANON 30659 AND 20 MG EE, COMPARED TO A COC CONTAINING 100 MG LEVONORGESTREL AND 20 MG EE. ORGANON.

CLINICAL PROTOCOL FOR A MULTICENTER, DOUBLE-BLIND, PARALLEL GROUP STUDY COMPARING THE INCIDENCE OF CLINICALLY SIGNIFICANT UPPER GASTROINTESTINAL ADVERSE EVENTS ASSOCIATED WITH SC-58635 400MG BID TO THAT OF IBUPROFEN 800MG TID IN PATIENTS WITH OSTEOARTHIRITIS OR RHEUMATOID ARTHRITIS. SEARLE.

TOPICAL CILODEXÔ SUSPENSION COMPARED TO CILOXANâ SOLUTION AND CORTISPORINâ SUSPENSION FOR TREATMENT OF PATIENTS WITH MODERATE TO SEVERE ACUTE OTITIS EXTERNA (AOE). ALCON LABORATORIES.

ANTIHYPERTENSIVE EFFECTS OF OMAPATRILAT VS. LISINOPRIL IN BLACK SUBJECTS WITH HYPERTENSION. BRISTOL MYERS SQUIBB

A RANDOMIZED, DOUBLE-BLIND, COMPARATOR-CONTROLLED TRIAL TO EVALUATE THE PHARMACODYNAMIC EFFECTS, PHARMACOKINETICS AND SAFETY OF M100240 IN SUBJECTS WITH ESSENTIAL HYPERTENSION TREATED FOR 4 WEEKS. AVENTIS.

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE THIRTY-THREE

RESEARCH ACTIVITIES (CONTINUED):

.
A DOUBLE-BLIND, RANDOMIZED, PLACEBO AND ACTIVE CONTROLLED, PARALLEL GROUP, DOSE-FINDING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ONCE DAILY ORAL ADMINISTRATION OF 5 MG, 10 MG, 25 MG, AND 50 MG OF M100240 FOR 8 WEEKS IN SUBJECTS WITH MILD-TO-MODERATE ESSENTIAL HYPERTENSION. AVENTIS.

A RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, FIXED DOSE STUDY TO COMPARE THE BLOOD PRESSURE RESPONSE OF PATIENTS WITH MODERATE HYPERTENSION RECEIVING LERCANIDIPINE 10 MG, 20 MG, 40 MG, OR PLACEBO. FOREST.

OMAPATRILAT CARDIOVASCULAR TREATMENT ASSESSMENT VERSUS ENALAPRIL (OCTAVE). BRISTOL-MYERS.

A COMPARISON OF THE ANALGESIC EFFICACY AND SAFETY OF TRAMADOL HCL/ACETAMINOPHEN VERSUS PLACEBO FOR THE TREATMENT OF THE SIGNS AND SYMPTOMS OF OSTEOARTHRITIS IN SUBJECTS RECEIVING A COX-2 SELECTIVE INHIBITOR. ORTHO-MCNEIL.

RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, TWO YEAR PARALLEL GROUP STUDY OF THE EFFICACY AND SAFETY OF GI198745 0.5 MG IN THE TREATMENT AND PREVENTION OF PROGRESSION OF BENIGN PROSTATIC HYPERPLASIA. GLAXO WELLCOME.

DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED COMPARISON STUDY OF THE EFFICACY AND UPPER GASTROINTESTINAL SAFETY OF VALDECOXIB 5 MG, 10 MG, AND 20 MG QD AND NAPROXEN 500 MG BID IN TREATING THE SIGNS AND SYMPTOMS OF OSTEOARTHRITIS OF THE KNEE. SEARLE.

PLACEBO-CONTROLLED STUDY OF OMAPATRILAT, IN ELDERLY SUBJECTS WITH MILD T MODERATE HYPERTENSION. BRISTOL-MYERS.

RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP, DOUBLE BLIND PILOT STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ROFECOXIB 12.5 MG, ROFECOXIB 25 MG, AND CELECOXIB 200 MG IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE. MERCK.

A 26- WEEK RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP STUDY TO COMPARE THE EFFICACY, SAFETY AND TOLERABILITY OF ROSIGLITAZONE (2 MG BID AND 4 MG BID) VERSUS PLACEBO IN COMBINATION WITH GLYBURIDE AND METFORMIN IN PATIENTS WITH TYPE 2 DIABETES MELLITUS. SMITHKLINE.

DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, 12-WEEK TRIAL TO ASSESS THE EFFICACY AND SAFETY OF MK-0663 IN PATIENTS WITH CHRONIC LOW BACK PAIN. MERCK.

DOUBLE-BLIND, RANDOMIZED, ACTIVE-CONTROLLED COMPARISON STUDY OF THE ANTIHYPERTENSIVE, RENAL, AND METABOLIC EFFECTS OF EPLERENONE VERSUS ENALAPRIL IN PATIENTS WITH TYPE 2 DIABETES MELLITUS, ALBUMINURIA, AND HYPERTENSION. SEARLE & CO.

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE THIRTY-FOUR

RESEARCH ACTIVITIES (CONTINUED):

MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, FACTORIAL EFFICACY TRIAL OF COMBINATION THERAPY OF METOPROLOL SUCCINATE PLUS FELODIPINE (ONCE DAILY DOSING) IN ADULT PATIENTS WITH HYPERTENSION. ASTRA PHARMACEUTICALS, L.P.

EVALUATION OF THE EFFICACY OF PHENAZOPYRIDINE HYDROCHLORIDE (FORMULA PD-F-0016) AS A URINARY ANALGESIC IN WOMEN WITH URINARY TRACT INFECTIONS. ADVANCED CARE PRODUCTS

MULTI-CENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF KETOTOP® (A TOPICAL PLASTER CONTAINING KETOPROFEN) IN THE TREATMENT OF OSTEOARTHRITIS OF THE KNEE. UNITHER PHARMACEUTICALS, INC.

A COMPARATIVE STUDY OF LAVASTATIN XL WITH MEVACOR IN PATIENTS WITH HYPERCHOLESTEROLEMIA. AURA LABS.

A 6-WEEK RANDOMIZED DOUBLE-BLIND MULTICENTER TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ZD4522 (5,10, 20, 40, AND 80 MG) AND ATORVASTATIN (10, 20, 40, AND 80 MG) ACROSS THEIR RESPECTIVE DOSE RANGES IN THE TREATMENT OF SUBJECTS WITH HYPERCHOLESTEROLEMIA. ASTRAZENECA.

DOUBLE-BLIND, RANDOMIZED, PARALLEL STUDY, COMPARING ACTIVE CONTROLLED ETHICAL ESTRADIOL TD 7-DAY PATCH 40, 60, 80 µG/DAY TO ORAL PREMARIN® 0.625 MG/DAY IN THE TREATMENT OF VASOMOTOR SYMPTOMS IN POSTMENOPAUSAL WOMEN.

MULTI-CENTER, OPEN-LABEL STUDY EVALUATING THE SAFETY AND TOLERABILITY OF TRAMADOL HYDROCHLORIDE CONTROLLED-RELEASE TABLETS IN PATIENTS WITH CHRONIC PAIN. PURDUE PHARMA L.P.

A STUDY TO DETERMINE THE EFFECTIVENESS AND SAFETY OF TOPICALLY APPLIED ESTEROM® SOLUTION VERSUS VEHICLE IN PATIENTS WITH IMPAIRED RANGE OF MOTION ASSOCIATED WITH A PAINFUL SHOULDER. ENTROPIN, INC.

DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP COMPARISON OF THE EFFICACY AND SAFETY OF PROPRIAM, TRAMADOL (ULTRAM®), AND PLACEBO WITH AN OPEN LABEL EXTENSION IN THE TREATMENT OF PAIN ASSOCIATED WITH OSTEOARTHRITIS OF THE KNEE AND/OR HIP. ROBERTS LABORATORIES, INC.

MULTI-CENTER, CONTROLLED EVALUATION OF THE EFFICACY AND SAFETY OF REPEATED ORAL DOSES OF VICOPROFEN® (HYDROCODONE BITARTRATE WITH IBUPROFEN) VS. OXYCODONE HCI WITH ACETAMINOPHEN, IN PATIENTS WITH ACUTE LOW BACK PAIN. KNOLL PHARMACEUTICAL.

DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP, DOSE RESPONSE, MULTI-CENTER STUDY TO COMPARE THE SAFETY AND EFFICACY OF DILTIAZEM HCL EXTENDED RELEASE CAPSULES (G99) TO PLACEBO DOSED AT BEDTIME AND TO G99 DOSED IN THE MORNING IN PATIENTS WITH ESSENTIAL HYPERTENSION. BIOVAIL.

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE THIRTY-FIVE

RESEARCH ACTIVITIES (CONTINUED):

DOUBLE BLIND, PLACEBO-CONTROLLED, RANDOMIZED STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PROPHYLACTIC ADMINISTRATION OF PLECONARIL IN THE PREVENTION OF PICORNAVIRAL RESPIRATORY ILLNESS IN HEALTHY ADULT SUBJECTS. VIROPHARMA.

COMPARATIVE EFFICACY AND SAFETY OF NISOLDIPINE AND AMLODIPINE FOR THE TREATMENT OF BLACK SUBJECTS WITH HYPERTENSION (CESNA III) – 1518US/0008. ZENECA PHARMACEUTICALS.

DOUBLE-BLIND PLACEBO-CONTROLLED DOSE FINDING TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF R149524 IN SUBJECTS WITH SYMPTOMS OF GASTROESOPHAGEAL REFLUX DISEASE (GERD). JANSSEN.

A RANDOMIZED, DOUBLE-BLIND SAFETY AND EFFICACY STUDY OF LOSARTAN PLUS HYDROCHLOROTHIAZIDE VERSUS LOSARTAN AS FIRST-LINE THERAPY AFTER 6 WEEKS IN PATIENTS WITH SEVERE HYPERTENSION. MERCK

DOUBLE BLIND, RANDOMIZED, PARALLEL, PLACEBO-CONTROLLED, EFFICACY STUDY OF LOSARTAN POTASSIUM 100 MG –HYDROCHLOROTHIAZIDE 25 MG VERSUS LOSARTAN POTASSIUM 50 MG – HYDROCHLOROTHIAZIDE 12.5 MG IN PATIENTS WITH ESSENTIAL HYPERTENSION. MERCK.

DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED SIX WEEK COMPARISON STUDY OF THE EFFICACY OF VALDECOXIB 20 MG QD AND ROFECOXIB 25 MG QD IN RELIEVING THE SIGNS AND SYMPTOMS OF OSTEOARTHRITIS OF THE KNEE. PHARMACIA.

MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED STUDY TO COMPARE THE SAFETY AND EFFICACY OF NIZATIDINE EXTENDED RELEASE (ER) 150 MG TWICE DAILY (BID), NIZATIDINE ER 300 MG DAILY (QD) AND PLACEBO IN THE TREATMENT OF SUBJECTS WITH SYMPTOMATIC, ENDOSCOPICALLY CONFIRMED EROSIVE GASTROESOPHAGEAL REFLUX DISEASE (GERD). RELIANT.

PHASE II, DOSE-RESPONSE, SAFETY AND EFFICACY STUDY OF ORAL TMX-67 IN SUBJECTS WITH GOUT. TAP.

PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND STUDY COMPARING FAROPENEM DALOXATE 300 MG PO BID FOR SEVEN DAYS WITH TRIMETHOPRIM/SULFAMETHOXAZOLE 160/1180 MG PO BID FOR SEVEN DAYS IN THE TREATMENT OF PATIENTS WITH ACUTE, UNCOMPLICATED LOWER URINARY TRACT INFECTIONS. BAYER.

RANDOMIZED, DOUBLE BLIND, PARALLEL, PLACEBO-CONTROLLED, MULTICENTER TRIAL TO STUDY THE EFFICACY, SAFETY, AND STEADY STATE PHARMACOKINETICS OF RELPRO (DOSE LEVELS: 80 MG, 120 MG, 160 MG, 640 MG) IN PATIENTS WITH ESSENTIAL HYPERTENSION. RELIANT.
A DOSE RANGING STUDY OF NK-104 IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA. SANKYO.

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE THIRTY-SIX

RESEARCH ACTIVITIES (CONTINUED):

RANDOMIZED, PLACEBO-CONTROLLED, FACTORIAL DESIGN STUDY OF CS-866 AND HYDROCHLOROTHIAZIDE IN PATIENTS WITH ESSENTIAL HYPERTENSION. PARAGON BIOMEDICAL.

MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, CLINICAL EVALUATION OF ORAL GI262570 SODIUM TABLETS (2.5 MG, 5 MG, 7.5 MG GI262570) IN COMBINATION WITH METFORMIN FOR 26 WEEKS DURATION IN SUBJECTS WITH TYPE 2 DIABETES

MELLITUS WHO ARE INADEQUATELY CONTROLLED ON A MAXIMUM DOSE OF METFORMIN. GLAXO WELLCOME.

PROSPECTIVE, DOUBLE-BLIND, RANDOMIZED, PARALLEL EFFICACY STUDY OF A LOSARTAN TREATMENT REGIMEN VERSUS PLACEBO IN THE TREATMENT OF PATIENTS WITH ISOLATED SYSTOLIC HYPERTENSION. MERCK.

RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP STUDY OF THE SAFETY AND EFFICACY OF LATRANAL COMPARED TO DOXEPIN CREAM AND PLACEBO IN PATIENTS WITH CHRONIC LOW BACK PAIN. PRAECIS.

NESTED CASE-CONTROLLED STUDY OF POTENTIAL RISK FACTORS FOR ANGIOEDEMA AND ANGIOEDEMA-LIKE EVENTS IN SUBJECTS PREVIOUSLY EXPOSED TO OMAPATRILAT. BRISTOL-MYERS SQUIBB.

RANDOMIZED, DOUBLE BLIND, ACTIVE-CONTROLLED COMPARISON OF OMAPATRILAT AND ENALAPRIL IN SUBJECTS WITH NEWLY DIAGNOSED OR ESTABLISHED HYPERTENSION. BRISTOL-MYERS.

EVALUATE THE SAFETY AND EFFICACY OF TAK-637 (30 MG BID, 60 MG BID AND 120 MG BID) VERSUS PLACEBO IN SUBJECTS WITH IRRITABLE BOWEL SYNDROME, INCORPORATING AMENDMENT NO. 1. TAP.

RANDOMIZED, DOUBLE BLIND, PARALLEL COMPARISON OF ESTERIFIED ESTROGENS AND METHYL TESTOSTERONE VERSUS ESTERIFIED ESTROGENS ALONE FOR THE TREATMENT OF LOSS SEXUAL INTEREST ASSOCIATED WITH SURGICAL MENOPAUSE. SOLVAY PHARMACEUTICALS.

COMPARATIVE EFFICACY STUDY OF ESOMEPRAZOLE MAGNESIUM (40 MG QD) AND LANSOPRAZOLE (30 MG QD) IN PATIENTS WITH EROSIVE ESOPHAGITIS. ASTRAZENECA.

DOSE RANGING STUDY WITH THREE DOSES OF A TERCONAZOLE CELLULOSIC VAGINAL SUPPOSITORY (CVS) COMPARED TO TERAZOL® VAGINAL CREAM 0.4% IN THE TREATMENT OF VULVOVAGINAL CANDIDIASIS. PERSONAL PRODUCTS.

OPEN-LABEL, MULTINATIONAL, MULTICENTER, EXTENSION TRIAL TO ASSESS THE LONG-TERM SAFETY AND EFFICACY OF ZD4522 IN SUBJECTS IN THE ZD4522 CLINICAL TRIAL PROGRAM.

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE THIRTY-SEVEN

RESEARCH ACTIVITIES (CONTINUED):

A PHASE II, RANDOMIZED, DOUBLE BLINDED, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER, CLINICAL TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF THREE DOSES OF LAS34475 VS PLACEBO AND NAPROXEN 500 MG IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE. ALMIRALL.

DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP COMPARISON STUDY TO EVALUATE THE ROLE OF THE ADDITION OF AMARYL TO NIDDM PATIENTS NOT RESPONDING TO MAXIMUM DOSE METFORMIN AND THIAZOLININEDIONE. AVENTIS.

ANTIHYPERTENSIVE EFFICACY OF ADDING CANDESARTAN CILEXETIL TO LISINOPRIL IN COMPARISON TO UP-TITRATION OF LISINOPRIL. ASTRAZENECA.

MULTICENTER, RANDOMIZED, DOUBLE-BLIND, SAFETY AND EFFICACY STUDY OF H 199/18 WITH AMOXICILLIN PLUS CLARITHROMYCIN COMPARED TO H 199/18 WITH CLARITHROMYCIN FOR THE ERADICATION OF HELICOBACTER PYLORI IN SUBJECTS WITH ACTIVE DUODENAL ULCER OR HISTORY OF DUODENAL ULCER DISEASE. ASTRA PHARMACEUTICALS.

DOSE FINDING, EFFICACY, SAFETY AND PHARMACOKINETICS OF AR-H039242XX IN PATIENTS WITH TYPE 2 DIABETES. ASTRAZENECA.

12 WEEKS TREATMENT WITH 250 UG ROFLUMILAST VERSUS 500 UG ROFLUMILAST VERSUS 10 MG MONTELUKAST VERSUS PLACEBO IN-PATIENTS WITH ASTHMA (BY217/FK1 013). ALTANA.

PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF 20 MG OROSâ CYCLOBENZAPRINE QD AND 10 MG IMMEDIATE RELEASE CYCLOBENZAPRINE (FLEXERILâ) TID IN OUTPATIENTS WITH ACUTE MUSCLE SPASMS ASSOCIATED WITH ACUTE MUSCULOSKELETAL PAIN. ALZA.

6-WEEK, OPEN-LABEL, DOSE-COMPARISON STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ROSUVASTATIN VERSUS ATORVASTATIN, CERIVASTATIN, PRAVASTATIN, AND SIMVASTATIN IN SUBJECTS WITH HYPERCHOLESTEROLEMIA. ASTRAZENECA.

OPEN-LABEL, RANDOMIZED, MULTI-CENTER, PHASE IIIB, PARALLEL GROUP SWITCHING STUDY TO COMPARE THE EFFICACY AND SAFETY OF LIPID LOWERING AGENTS ATORVASTATIN AND SIMVASTATIN WITH ROSUVASTATIN IN HIGH RISK SUBJECTS WITH TYPE IIA AND IIB HYPERCHOLESTEROLEMIA. ASTRAZENECA.

DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP COMPARISON OF THE EFFICACY AND SAFETY OF EXTENDED RELEASE TRAMADOL (TRAMADOL ER) 300 MG AND 200 MG TO PLACEBO IN THE TREATMENT OF CHRONIC LOWER BACK PAIN. BIOVAIL.

EVALUATE THE EFFICACY AND SAFETY OF COMBINATION ORAL CONTRACEPTIVE REGIMENS UTILIZING ETHINYL ESTRADIOL DURING THE PILL-FREE INTERVAL FOR PREVENTION OF PREGNANCY IN WOMEN. BARR.

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE THIRTY-EIGHT

RESEARCH ACTIVITIES (CONTINUED):

RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, FIXED-DOSE, CROSS-OVER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF 20 MG OF VARDENAFIL GIVEN ON DEMAND IN MALES WITH ERECTILE DYSFUNCTION AND A DIAGNOSIS OF DIABETES MELLITUS AND/OR HYPERTENSION AND/OR HYPERLIPIDEMIA. BAYER.

CHRONIC-DOSE COMPARISON OF THE EFFICACY AND SAFETY OF ALBUTEROL-HFA-MDI (SALAMOLTM), ALBUTEROL-HFA-BOI (SALAMOL EASI-BREATHE TM ) AND PROVENTILâ HFA IN MILD0-TO-MODERATE ASTHMATICS (“STUDY”). BAKER.

DOUBLE-BLIND, MULTI-CENTER, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP DOSING STUDY EVALUATING THE EFFECTS OF NEBIVOLOL ON BLOOD PRESSURE PATIENTS WITH MILD TO MODERATE HYPERTENSION. BERTEK.

PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, MULTI-CENTER, TITRATION STUDY COMPARING THE SAFETY AND EFFICACY OF DILTIAZEM EXTENDED RELEASE CAPSULES (G99) TAKEN AT BEDTIME TO AMLODIPINE TAKEN IN THE MORNING IN ACHIEVING OPTIMAL BLOOD PRESSURE CONTROL IN AFRICAN AMERICAN PATIENTS WITH MILD TO MODERATE ESSENTIAL HYPERTENSION. BIOVAIL.

RANDOMIZED, DOUBLE BLIND, DOSE RANGING, DOSE COMPARISON-CONTROLLED TRIAL TO DETERMINE THE SAFETY AND EFFICACY OF BMS-298585 IN SUBJECTS WITH TYPE 2 DIABETES. BRISTOL-MYERS SQUIBB.

MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY TO EVALUATE THE EFFECT OF A CONTINUOUSLY COMBINED HRT PREPARATION CONTAINING 1 MG ESTRADIOL AND 3 MG DROSPIRENONE ON BLOOD PRESSURE IN MILDLY HYPERTENSIVE POSTMENOPAUSAL WOMEN. BERLEX.

PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND STUDY COMPARING FAROPENEM DALOXATE 300 MG PO BID FOR FIVE DAYS WITH TRIMETHOPRIM/SULFAMETHOXAZOLE 160/800 MG PO BID FOR FIVE DAYS IN THE TREATMENT OF PATIENTS WITH ACUTE, UNCOMPLICATED LOWER URINARY TRACT INFECTIONS. BAYER.

MULTI-CENTER, DOUBLE-BLIND, PLACEBO CONTROLLED, GROUP COMPARISON STUDY TO INVESTIGATE THE EFFICACY, TOLERABILITY AND SAFETY OF BAY 12-9566 AS COMPARED TO PLACEBO, IN THE TREATMENT OF PATIENTS WITH MILD TO MODERATE OSTEOARTHRITIS OF THE KNEE, OVER 3 YEARS. BAYER.

RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED TRIAL TO EVALUATE THE SAFETY AND EFFICACY OF ROSIGLITAZONE ADDED ON TO A BACKGROUND OF METFORMIN/GLYBURIDE TABLETS IN SUBJECTS WITH TYPE 2 DIABETES MELLITUS WHO HAVE INADEQUATE GLYCEMIC CONTROL ON METFORMIN/GLYBURIDE THERAPY. BRISTOL-MYERS SQUIBB.

MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP TRIAL COMPARING THE SAFETY AND EFFICACY OF METFORMIN/GLYBURIDE TO PIOGLITAZONE AS FIRST LINE THERAPY IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO HAVE INADEQUATE GLYCEMIC CONTROL WITH DIET AND EXERCISE. BRISTOL-MYERS SQUIBB.
LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE THIRTY-NINE

RESEARCH ACTIVITIES (CONTINUED):

RANDOMIZED, DOUBLE BLIND, DOSE-RANGING, PLACEBO-CONTROLLED TRIAL TO DETERMINE THE LIPID-LOWERING EFFICACY AND SAFETY OFBMS-298585 ALONE AND IN COMBINATION WITH PRAVASTATIN IN SUBJECTS WITH MIXED DYSLIPIDEMIA. BRISTOL-MYERS SQUIBB.

DOUBLE-BLIND, MULTI-CENTER, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP DOSING STUDY EVALUATING THE EFFECTS OF NEBIVOLOL ON BLOOD PRESSURE IN PATIENTS WITH MILD TO MODERATE HYPERTENSION. BERTEK.

MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP, DOSE-TO-EFFECT STUDY TO COMPARE THE SAFETY AND EFFICACY OF BEDTIME DOSING OF DILTIAZEM HCI EXTENDED RELEASE TABLETS (G99) TO RAMIPRIL IN PATIENTS WITH STAGES I AND II ESSENTIAL HYPERTENSION. BIOVAIL.

RANDOMIZED, DOUBLE BLIND, MULTI-CENTER, FIXED DOSE, CROSS-OVER STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF 20 MG OF VARDENAFIL GIVEN ON DEMAND IN COMPARISON TO 100 MG OF SILDENAFIL GIVEN ON DEMAND IN MALES WITH ERECTILE DYSFUNCTION. BAYER.

DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, DOSE RANGING COMPARISON OF THE EFFICACY AND SAFETY OF EXTENDED RELEASE OXYMORPHONE AND PLACEBO IN THE TREATMENT OF OSTEOARTHRITIS OF THE KNEE AND/OR HIP. ENDO.

MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP DOSE RESPONSE STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND DOSE RESPONSE RELATIONSHIP OF EMD 221829 GIVEN ON-DEMAND FOR TWELVE WEEKS IN MEN WITH ERECTILE DYSFUNCTION. EMD PHARMACEUTICALS.

RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, CLINICAL TRIAL USING 24-HOUR AMBULATORY BLOOD PRESSURE MONITORING TO COMPARE THE BLOOD PRESSURE OF PATIENTS WITH MODERATE HYPERTENSION RECEIVING LERCANIDIPINE 10 MG, 20 MG, 40 MG, OR PLACEBO. FOREST.

16-WEEK, OPEN-LABEL INVESTIGATION OF DRUG RESPONSE TO MEVACORâ IN RELATIONSHIP TO GENE VARIANTS (HAP TM MARKERS) IN ADULT SUBJECTS WITH PRIMARY HYPERCHOLESTEROLEMIA. GENAISSANCE.

MULTICENTER, DOUBLE BLIND, PLACEBO-CONTROLLED STUDY OF 20 MG, TWICE DAILY TROSPIUM CHLORIDE FOR 12 WEEKS FOLLOWED BY A 9-MONTH, OPEN-LABEL TREATMENT PHASE IN PATIENTS WITH OVERACTIVE BLADDER. INTERNEURON.

MULTICENTER, RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED STUDY TO ASSESS THE EFFICACY AND SAFETY OF RWJ-270201 IN THE TREATMENT OF ACUTE INFLUENZA A AND B INFECTIONS IN HEALTHY ADULTS. RW JOHNSON PHARMACEUTICAL RESEARCH.

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE FORTY

RESEARCH ACTIVITIES (CONTINUED):

A TRIAL TO EVALUATE THE LONG-TERM TOLERABILITY AND SAFETY OF R149524 COMPARED WITH PLACEBO IN SUBJECTS WITH SYMPTOMS OF GASTROESOPHAGEAL REFLUX DISEASE (GERD). JANSSEN

RANDOMIZED, DOUBLE BLIND, LONG-TERM COMPARATIVE STUDY EVALUATING THE SAFETY AND EFFICACY OF ACETAMINOPHEN (4000 MG/DAY) AND NAPROXEN (750 MG/DAY) IN THE TREATMENT OF OSTEOARTHRITIS OF THE HIP OR KNEE. MCNEIL.

RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, DOSE-FINDING, MULTICENTER STUDY OF SANDOSTATIN LARâ DEPOT (20 MG, 40 MG, 60 MG) IN PATIENTS WITH PRIMARY INSULIN HYPERSECRETION (PIH) AND AT LEAST MODERATE OBESITY. NOVARTIS.

TWENTY-SIX WEEK, DOUBLE BLIND, MULTICENTER, RANDOMIZED, PARALLEL, ACTIVE-CONTROLLED (ACTOSâ PLUS TRICORâ) STUDY TO INVESTIGATE SAFETY AND EFFICACY. NOVO NORDISK.

NNC 61-0029 IN COMBINATION WITH GLUCOPHAGEâ VERSUS ACTOSâ PLUS GLUCOPHAGEâ IN TYPE 2 DIABETES: A SIX-MONTH, DOUBLE-BLIND (WITH OPEN-LABELED GLUCOPHAGEâ), MULTICENTER, RANDOMIZED, PARALLEL STUDY OF EFFICACY AND SAFETY. NOVO NORDISK.

FIFTY-TWO WEEK DOUBLE BLIND, PARALLEL, ACTIVE-CONTROLLED (DIABETAâ AND GLUCOPHAGEâ) STUDY (FOLLOWED BY A FIFTY-TWO WEEK OPEN LABELED EXTENSION) TO INVESTIGATE SAFETY AND EFFICACY. NOVO.

MULTICENTER PROSPECTIVE, RANDOMIZED, DOUBLE-BLINDED, PARALLEL GROUP STUDY COMPARING THE EFFECTS OF LOTRELâ (5/20 MG) TO AMLODIPINE (5 MG) AND BENAZEPRIL (20 MG) ON SYSTOLIC BLOOD PRESSURE AND PULSE PRESSURE IN PATIENTS WITH SYSTOLIC HYPERTENSION. NOVARTIS.

OPEN-LABEL RUN-IN, FOLLOWED BY A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL GROUP STUDY TO SHOW THE EFFECTIVENESS OF BUPRENORPHINE TRANSDERMAL DELIVERY SYSTEM (BTDS) – 5,10 AND 20 MG THERAPY IN THE MANAGEMENT OF PATIENTS WITH CHRONIC NON-MALIGNANT PAIN SYNDROMES RESPONSIVE TO OPIOID COMBINATION THERAPY. NAPP.

RANDOMIZED, DOUBLE BLIND, MULTI-CENTER STUDY TO ASSESS THE SAFETY OF LONG-TERM ADMINISTRATION OF TWO DOSE LEVELS OF NBI-34060 IN PATIENTS WITH PRIMARY INSOMNIA. NEUROCRINE.

A MULTINATIONAL, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, ACTIVE CONTROLLED, COMPARATIVE TRIAL, TO ASSESS THE ENDOMETRIAL HISTOLOGICAL PROFILE FOLLOWING TREATMENT WITH TIBOLONE (ORG OD 14) VERSUS CONJUGATED ESTROGEN (CE) PLUS MEDROXYPROGESTERONE ACETATE (MPA) IN POSTMENOPAUSAL WOMEN. ORGANON.

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE FORTY-ONE

RESEARCH ACTIVITIES (CONTINUED):

A RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF NORGESTIMATE 180-250 MCG/25 EE IN THE TREATMENT OF MODERATE ACNE VULGARIS (THE “STUDY”). ORTHO-MCNEIL.

MULTICENTER, RANDOMIZED, OPEN-LABEL, PARALLEL GROUP STUDY TO EVALUATE THE ENDOMETRIAL SAFETY FOLLOWING TREATMENT WITH ORTHO-PREFESTâ COMPARED TO PREMPROTM IN POSTMENOPAUSAL WOMEN. ORTHO-MCNEIL.

RANDOMIZED, OPEN-LABEL, COMPARATIVE, MULTI-CENTER TRIAL TO EVALUATE CONTRACEPTIVE EFFICACY, CYCLE-CONTROL, SAFETY AND ACCEPTABILITY OF A MONOPHASIC COC CONTAINING 200 MCG ORG 30659 AND 20 MCG EE, COMPARED TO A COC CONTAINING 100 MCG LEVONORGESTREL AND 20 MCG EE. ORGANON.

MULTICENTER, DOUBLE BLIND, RANDOMIZED, PLACEBO CONTROLLED STUDY OF ELETRIPTAN (20 AND 40 MG) VERSUS PLACEBO IN EARLY TREATMENT OF MIGRAINE. PFIZER.

DOUBLE BLIND, RANDOMIZED THREE ARM, TWO PERIOD, CROSSOVER STUDY TO COMPARE CELECOXIB, ACETAMINOPHEN, AND PLACEBO IN PATIENTS WITH OSTEOARTHRITIS OF THE HIP OR KNEE. PHARMACIA.

RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTIPLE-DOSE, MULTICENTER, PARALLEL GROUP STUDY OF THE ANALGESIC EFFECT OF VALDECOXIB 40 MG QD AND PLACEBO IN PATIENTS WITH CHRONIC LOW BACK PAIN. PHARMACIA.

DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP COMPARISON STUDY OF THE SAFETY OF VALDECOXIB VS ROFECOXIB IN TREATED HYPERTENSIVE PATIENTS WITH OSTEOARTHRITIS. PHARMACIA.

DOUBLE-BLIND, RANDOMIZED, PARALLEL-GROUP COMPARISON STUDY OF THE SAFETY AND EFFICACY OF CELECOXIB, ROFECOXIB AND NAPROXEN IN STABLE, TREATED HYPERTENSIVE PATIENTS WITH OSTEOARTHRITIS AND TYPE 2 DIABETES MELLITUS. PFIZER.

RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP STUDY OF THE SAFETY AND EFFICACY OF LATRANAL COMPARED TO PLACEBO USING ONCE, TWICE, OR THREE TIMES DAILY DOSING IN PATIENTS WITH CHRONIC LOW BACK PAIN. PRAECIS.

RANDOMIZED, MULTICENTER, DOUBLE-BLIND, DOUBLE-DUMMY TRIAL COMPARING AZITHROMYCIN 500 MG DAILY FOR 3 DAYS WITH CLARITHROMYCIN 1 GRAM DAILY FOR 10 DAYS FOR THE TREATMENT OF ACUTE BACTERIAL EXACERBATION OF CHRONIC BRONCHITIS. PFIZER.

THREE YEAR, OPEN LABEL, ANALGESIC EFFICACY, SAFETY, ACCEPTABILITY, TOLERABILITY AND QUALITY OF LIFE REGISTRY OF CONTROLLED RELEASE OXYCODONE TABLETS (OXYCONTINâ) IN CHRONIC NON-CANCER PAIN. PURDUE.

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE FORTY-TWO

RESEARCH ACTIVITIES (CONTINUED):

RANDOMIZED, DOUBLE-BLIND PLACEBO-CONTROLLED MULTI CENTER STUDY MEASURING THE EFFECTS OF CI-991 ON NON-INSULIN DEPENDENT DIABETES MELLITUS (NIDDM) PATIENTS REQUIRING INSULIN. SPECTRUM PHARMACEUTICAL.

OPEN-LABEL, LONG-TERM EXTENSION STUDY OF PIOGLITAZONE IN TYPE 2 DIABETES MELLITUS PATIENTS (NON-INSULIN DEPENDENT DIABETES MELLITUS, NIDDM). TAKEDA AMERICA RESEARCH.

RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRIAL OF THE EFFECT OF WEEKLY, AZITHROMYCIN ON THE INCIDENCE OF CORONARY ARTERY DISEASE IN SUBJECTS WITH EVIDENCE OF EXPOSURE TO C. PNEUMONIAE. PFIZER.

STUDY OF THE SAFETY AND EFFICACY OF LASOFOXIFENE FOR THE PREVENTION OF BONE LOSS AND FOR LIPID LOWERING IN POSTMENOPAUSAL WOMEN AT RISK FOR OSTEOPOROSIS. PFIZER.

SAFETY AND EFFICACY OF PNU-182716 VERSUS ROSIGLITAZONE: A ONE-YEAR, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, ACTIVE COMPARATOR STUDY. PHARMACIA & UPJOHN.

OPEN-LABEL SAFETY STUDY OF LATRANAL IN PATIENTS WHO HAVE PREVIOUSLY PARTICIPATED IN A PHASE 2 OR PHASE 3 LATRANAL STUDY. PRAECIS.

DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED SIX WEEK COMPARISON STUDY OF THE EFFICACY OF CELECOXIB 200 MG QD AND ROFECOXIB 25 MG QD IN RELIEVING THE SIGNS AND SYMPTOMS OF OSTEOARTHRITIS OF THE KNEE. PHARMACIA.

OPEN-LABEL, RANDOMIZED, MULTI-CENTER CLINICAL TRIAL TO ASSESS THE LONG-TERM SAFETY OF NIZATIDINE EXTENDED RELEASE (ER) 150 MG TWICE DAILY, AND NIZATIDINE ER 300 MG ONCE DAILY IN SUBJECTS WITH EROSIVE GASTROESOPHAGEAL REFLUX DISEASE. RELIANT.

PHASE III, 12-MONTH, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP, PLACEBO CONTROLLED, EFFICACY AND SAFETY STUDY OF AXOKINEâ IN OVERWEIGHT AND OBESE SUBJECTS WITH A 12-MONTH OPEN-LABEL EXTENSION PHASE. REGENERON.

DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF SUSTAINED RELEASE (S)-OXYBUTYNIN IN SUBJECTS WITH SYMPTOMS OF OVERACTIVE BLADDER OF URGENCY, FREQUENCY, AND URINARY INCONTINENCE. SEPRACOR.

OPEN-LABEL EXTENSION STUDY OF SUSTAINED RELEASE (S)-OXYBUTYNIN IN SUBJECTS WITH SYMPTOMS OF OVERACTIVE BLADDER. SEPRACOR.

RANDOMIZED, DOUBLE-BLIND, MULTICENTER STUDY COMPARING THE EFFECTS OF CARVEDILOL AND METOPROL ON GLYCEMIC CONTROL IN HYPERTENSIVE PATIENTS WITH TYPE II DIABETES MELLITUS. SMITHKLINE BEECHAM.

OPEN-LABEL, LONG-TERM TOLERABILITY STUDY OF PIOGLITAZONE (AD-4833) IN TYPE 2 DIABETES MELLITUS PATIENTS (NON-INSULIN DEPENDENT DIABETES MELLITUS, NIDDM). TAKEDA PHARMACEUTICALS.

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE FORTY-THREE

RESEARCH ACTIVITIES (CONTINUED):

MULTICENTER EFFICACY STUDY COMPARING EMD 90 171, A ONCE A WEEK ESTRADIOL-LEVONORGESTREL COMBINATION TRANSDERMAL SYSTEM (15 CM2 1% ESTRADIOL/1 % LEVONORGESTREL TDS, 15 CM2 1% ESTRADIOL/0.35% LEVONORGESTREL TDS), WITH PLACEBO IN THE TREATMENT OF VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE. SOLVAY PHARMACEUTICALS.

PHASE III, SIX-MONTH, OPEN-LABEL, FLEXIBLE DOSE, SAFETY EXTENSION STUDY OF UPRIMAâ TABLETS (2 AND 3 MG) IN TREATMENT OF MALE ERECTILE DYSFUNCTION. TAP PHARMACEUTICAL.

PHASE II, OPEN-LABEL STUDY, TO ASSESS THE LONG-TERM SAFETY OF ORAL TMX-67 IN SUBJECTS WITH GOUT. TAP PHARMACEUTICAL.

PHASE III, DOUBLE-BLIND, RANDOMIZED, PARALLEL STUDY EVALUATING THE SAFETY AND EFFICACY OF UPRIMAâ (APOMORPHINE HCL TABLETS) SUBLINGUAL (2 AND 3 MG) IN THE TREATMENT OF MALE ERECTILE DYSFUNCTION. TAP.

PHASE II, DOSE-RESPONSE STUDY OF ORAL NO-1886 IN SUBJECTS WITH MARKED HYPERTRIGLYCERIDEMIA. TAP PHARMACEUTICALS.

RANDOMIZED, OPEN-LABEL ASSESSMENT OF RATE OF REMISSION OF VENLAFAXINE EXTENDED RELEASE (ER) VS. SEROTONIN-SELECTIVE REUPTAKE INHIBITORS (SSRIS), WHEN STUDIED BY USING GUIDANCE BASED ON TREATMENT GUIDELINES AND LENGTH OF TREATMENT. WYETH-AYERST.

MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY COMPARING OXYBUTYNIN TRANSDERMAL SYSTEMS VERSUS TOLTERODINE LONG ACTING CAPSULES IN PATIENTS WITH OVERACTIVE BLADDER. WATSON LABORATORIES.

RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 24 MONTH, DOSE-RANGING, MULTI-CENTER STUDY COMPARING EMTDS TO PLACEBO IN THE PREVENTION OF BONE LOSS IN HYSTERECTOMIZED POSTMENOPAUSAL WOMEN. WATSON LABORATORIES.

A 12-WEEK RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED MULTICENTER TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF ZD4522 (5 AND 10 MG) AND ATORVASTATIN (10 MG) IN THE TREATMENT OF SUBJECTS WITH HYPERCHOLESTEROLEMIA. ZENECA.

MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL GROUP, 28-WEEK STUDY TO EVALUATE THE EFFICACY AND SAFETY OF EZETIMIBE AND SIMVASTATIN CO-ADMINISTRATION VERSUS ATORVASTATIN IN PATIENTS WITH HYPERCHOLESTEROLEMIA. MERCK.

MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP DOSE RESPONSE STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND DOSE RESPONSE RELATIONSHIP OF EMD 221 829 GIVEN ON-DEMAND FOR TWELVE WEEKS IN MEN WITH ERECTILE DYSFUNCTION. EMD PHARMACEUTICALS.

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE FORTY-FOUR

RESEARCH ACTIVITIES (CONTINUED):

DOUBLE-BLIND RANDOMIZED, PLACEBO AND ACTIVE CONTROLLED, PARALLEL GROUP, DOSE-FINDING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ONCE DAILY ORAL ADMINISTRATION OF 5 MG, 10 MG, 25 MG, AND 50 MG OF M100240 FOR 8 WEEKS IN SUBJECTS WITH MILD-TO-MODERATE ESSENTIAL HYPERTENSION. AVENTIS.

A DOUBLE-BLIND, RANDOMIZED, PLACEBO AND ACTIVE CONTROLLED, PARALLEL GROUP, DOSE-FINDING STUDY TO EVALUATE THE EFFICACY AND SAFETY OF ONCE DAILY ORAL ADMINISTRATION OF 5 MG, 10 MG, 25 MG, AND 50 MG OF M100240 FOR 8 WEEKS IN SUBJECTS WITH MILD-TO-MODERATE ESSENTIAL HYPERTENSION. AVENTIS.

MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL STUDY COMPARING ZANTAC 75 mg and PRILOSEC 20 mg FOR POSTPRANDIAL AND NOCTURNAL HEARTBURN. PFIZER.

PROTOCOL C-2002-012 "A PLACEBO-CONTROLLED, DOUBLE-BLIND, RANDORRIZED, PARARLLED STUDY OF THE EFFICACY AND SAFETY OF DAPOXETINE HCI IN THE TREATMENT OF RAPID EJACULATION" ALZA

A RANDOMIZED, OPEN-LABEL, COMPARATIVE, MULTI-CENTER TRIAL TO EVALUATE CONTRACEPTIVE EFFICACY, CYCLE-CONTROL, SAFETY AND ACCEPTABILITY OF A MONOPHASIC COC CONTAINING 200MCG ORG 30659 AND 20MCG EE, COMPARED TO A COC CONTAINING 100 MCG LEVONORGESTREL AND 20MCG EE. ORGANON

A PHASE III, RANDOMIZED, MULTICENTER CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF COMBINATION ORAL CONTRACEPTIVE REGIMENS UTILIZING ETHINYL ESTRADIOL DURING THE PILL-FREE INTERVAL FOR PREVENTION OF PREGNANCY IN WOMEN. BARR

A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE SAFETY AND EFFICACY OF ROSIGLITAZONE MALEATE IN THE TREATMENT OF CHRONIC PLAGUE PSORIASIS. GLAXOSMITHKLINE

DULOXETINE VERSES PLACEBO IN THE TREATMENT OF PATIENTS WITH PAINFUL DIABETIC NEUROPATHY. ELI LILLY

AN OPEN LABEL, RANDOMIZED STUDY TO EVALUATE THE SAFETY OF 4 mg NICOTINE GUM IN SMOKERS WITH CERTAIN UNDERLYING DISEASE RESTRICTION SPECIFIED IN THE LABEL. SMOKING CESSATION. GLAXO-SMITHKLINE

A RANDOMIZED, DOUBLE-BLIND, MULTICENTER, POSITIVE CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF AMLODIPINE AND BENAZEPRIL ADMINISTERED IN COMBINATION COMPARED TO BENAZEPRIL ALONE .

STUDY OF THE EFFICACY AD TOLERABILITY OF ONCE DAILY CELEBREX (CELECOXIB) AND THREE TIMES DAILY IBUPROFEN vs. PLACEBO IN THE TREATMENT OF SUBJECTS WITH OSTEOARTHRITIS OF THE KNEE. PFIZER

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE FORTY-FIVE

RESEARCH ACTIVITIES (CONTINUED):

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, FIXED-DOSE, MULTICENTER STUDY OF WEIGHT-REDUCING, EFFECT AND SAFETY OF SR141716 IN OBESE PATIENTS WITH TYPE 2 DIABETES. SANOFI-SYNTHELABO

A DOUBLE-BLIND, RANDOMIZED, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING EVALUATION OF (S)-AMLODIPINE IN THE HYPERTENSIVE SUBJECTS WHICH SHALL BE CONDUCTED ACCORDING TO THE SPONSOR’S PROTOCOL 152-027. SEPRACOR

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP STUDY COMPARING THE EFFICACY OF LOTREL VS. AMLODIPINE IN THE TREATMENT OF MODERATE TO SEVERE HYPERTENSION. NOVARTIS

A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ADDITION OF MK-0767 TO PATIENTS WITH TYPE 2 DIABETES WITH INADEQUATE GLYCEMIC CONTROL ON COMBINED METFORMIN AND SULFONYLUREA THERAPY. MERCK

A MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP, 6-WEEK STUDY TO EVALUATE THE EFFICACY AND SAFETY OF EZETIMIBE 10 mg/DAY WHEN ADDED TO ONGOING THERAPY WITH A STATIN VERSUS STATIN THERAPY ALONE, IN PATIENTS WITH HYPERCHOLESTEROLEMIA WHO HAVE NOT REACHED NATIONAL CHOLESTEROL EDUCATION PROGRAM (NCEP) ADULT TREATMENT PANEL 9ATP) III TARGET LDL-CHOLESTEROL LEVEL. MERCK

A PHASE II 12-WEEK RANDOMIZED, DOUBLE-BLIND, FOUR ARM, PLACEBO-CONTROLLED, DOSE RANGING STUDY FOR SAFETY AND EFFICACY OF TAK-677 IN TYPE 2 DIABETIC. TAKEDA

SUBJECTS (GLYBURIDE TREATED or DIET CONTROLLED) AS MEASURED BY GLYCEMIC CONTROL. TAKEDA

A PLACEBO-CONTROLLED, EFFICACY AND SAFETY STUDY OF OLOPATADINE NASAL SPRAY FOR THE TREATMENT OF SEASONAL ALLERGIC RHINITIS. ALCON

MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GROUP COMPARISON OF THE REMISSION RATES FOR ONCE DAILY TREATMENT WITH ESOMEPRAZOLE 20 mg AND LANSOPRAZOLE 15 mg FOR SIX MONTHS IN PATIENTS WHOSE EE WAS HEALED.

A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE DUMMY, PARALLEL-GROUP EFFICACY STUDY COMPARING 8 WEEKS OF TREATMENT WITH ESOMEPRAZOLE MAGNESIUM (40 mg qd) to LANSOPRAZOLE (30 mg qd) FOR THE HEALING OF EROSIVE ESOPHAGITIS IN PATIENTS WITH MODERATE OR SEVERE EROSIVE ESOPHAGITIS.

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE FORTY-SIX

RESEARCH ACTIVITIES (CONTINUED):

A 12 WEEK MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PARALLEL-DESIGN STUDY OF 5% DAPSONE TOPICAL GEL AND VEHICLE CONTROL IN PATIENTS WITH ACNE VULGARIS. ATRIX

A PHASE III, RANDOMIZED, MULTICENTER, CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF COMBINATION ORAL CONTRACEPTIVE REGIMENS UTILIZING ETHINYL ESTRADIOL DURING THE PILL-FREE INTERVAL FOR PREVENTION OF PREGNANCY IN WOMEN. BARR

A RANDOMIZED, DOUBLE-BLIND COMPARISON OF AMLODIPINE MALEATE AND AMLODIPINE DESYLATE IN THE TREATMENT OF MILD TO MODERATE HYPERTENSION. Dr. REDDY'S LABORATORY

AN OPEN LABEL, RANDOMIZED STUDY TO EVALUATE THE SAFETY OF 4mg NICOTINE LOZENGES IN COMPARISON WITH 4 mg NICOTINE GUM IN SMOKERS WITH CERTAIN UNDERLYING DISEASE RESTRICTION SPECIFIED IN THE LABEL. GLAXOSMITHKLINE

A FOUR-ARM STUDY COMPARING THE ANALGESIC EFFICACY AND SAFETY OF TRAMADOL HCI ONCE A DAY 100, 200, AND 300 mg VERSUS PLACEBO FOR THE TREATMENT OF PAIN DUE TO OSTEOARTHRITIS OF THE KNEE. LABOPHARM
SAFETY AND EFFICACY OF HUMAN INSULIN INHALATION POWDER IN PATIENTS WITH TYPE 1 DIABETES MELLITUS. ELI LILLY

A MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP, 6-WEEK STUDY TO EVALUATE THE EFFICACY AND SAFETY OF EZETIMIBE 10 mg/DAY WHEN ADDED TO ONGOING THERAPY WITH A STATIN VERSUS STATING THERAPY ALONE, IN PATIENTS WITH HYPERCHOLESTEROLEMIA WHO HAVE NOT REACHED NATIONAL CHOLESTEROL EDUCATION PROGRAM (NCEP) ADULT TREATMENT PANEL 9ATP) III TARGET LDL-CHOLESTEROL LEVEL. MERCK

A PHASE III DOUBLE-BLIND, OUTPATIENT, EXTENSION STUDY TO ASSESS THE LONG TERM SAFETY OF TWO LEVELS OF NBI 34060IN ELDERLY PATIENTS WITH PRIMARY INSOMNIA. NEUROCRINE

A PHASE III RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, OUTPATIENT STUDY TO ASSESS THE EFFICACY AND SAFETY OF TWO DOSE LEVELS OF NBI 34060 IN ELDERLY PATIENTS WITH PRIMARY INSOMNIA. NEUROCRINE

A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL DESIGN, MULTI-SITE STUDY TO EVALUATE THE CLINICAL EQUIVALENCE OF TWO KETOCONAZOLE 2% SHAMPOOS IN PATIENT WITH TINEA (PITYRIASIS) VERSICOLOR.

EFFICACY OF WELCHOL AS AN ADD-ON TO SIMVASTATIN THERAPY. SANKYO

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE FORTY-SEVEN

RESEARCH ACTIVITIES (CONTINUED):

EFFICACY OF WELCHOL AS AN ADD-ON TO ATORVASTATIN THERAPY. SANKYO

EFFICACY OF WELCHOL AS AN ADD-ON TO PRAVASTATIN THERAPY. SANKYO

A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, FIXED-DOSE, MULTICENTER STUDY OF WEIGHT-REDUCING, EFFECT AND SAFETY OF SR141716 IN OBESE PATIENTS WITH TYPE 2 DIABETES. SANOFI

A PHASE II 12-WEEK RANDOMIZED, DOUBLE-BLIND, FOUR ARM, PLACEBO-CONTROLLED, DOSE RANGING STUDY FOR SAFETY AND EFFICACY OF TAK-677 IN TYPE 2 DIABETIC SUBJECTS (GLYBURIDE TREATED or DIET CONTROLLED) AS MEASURED BY GLYCEMIC CONTROL. TAKEDA

DOUBLE-BLIND, DOUBLE-DUMMY, RANDOMIZED PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY OF DEY BECLOMETHASONE DIPROPIONATE MONOHYDRATE NASAL SPRAY 0.042% IN ADOLESCENT AND ADULT PATIENTS WITH SEASONAL ALLERGIC RHINITIS. DEY PHARMACEUTICALS

SAFETY AND EFFICACY OF OLOPATADINE NASAL SPRAY 0.1% VS. OLOPATADINE NASAL SPRAY VEHICLE IN THE PREVENTION OF SYMPTOMS OF SEASONAL ALLERGIC RHINITIS WITH AZEIASTINE HCL NASAL SPRAY 0.1% (ASTELIN REGISTERED) AS A REFERENCE STANDARD. ALCON

A MULTICENTER, DOUBLE-BLIND ,RANDOMIZED ,VEHICLE-CONTROLLED, PARALLEL-GROUP STUDY COMPARING ALTANA INC.'S GENERIC SULFACETAMIDE SODIUM TOPICAL SUSPENSION, 10% TO KLARON LOTION, 10% (SODIUM SULFACETMIDE LOTION, 10%) AND BOTH ACTIVE TREATMENTS TO A VEHICLE IN THE TREATMENT OF ACNE VULGARIS. ALTANA

A 6 week, Randomized, Open - Label, Comparative Study to Evaluate the Efficacy and Safety of Rosuvastatun and Atrovastatin in the Treatment of Hypercholesterolemia in Hispanic Subjects. ASTRAZENECA

A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL DESIGN, MULTI-SITE STUDY TO EVALUATE THE CLINICAL EQUIVALENCE OF TWO KETOCONAZOLE 2% SHAMPOOS IN PATIENT WITH TENEA (PITYRIASIS) VERSICOLOR. NOVUM

Randomized, Double-Blind, Parallel Group Study to Compare the Safety and Efficacy of Ciprofloxacin Gastric Retentive (GR) QD and Ciprofloxacin Immediate Release (IR) BID in the Treatment of Uncomplicated Female Urinary Tract Infections. DEPOMED

A mulitcenter, Randomized, Double blind, parrallel group, placebo controlled efficacy study comparing 4 weeks of treatment with Esomeprazole 20 mg qd to placebo qd for the resolution of upper abdominal pain in patients with symptomatic gastroesphageal reflux disease. ASTRAZENECA

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE FORTY-EIGHT

RESEARCH ACTIVITIES (CONTINUED):

OPEN-LABEL USE OF AMLODIPINE MALEATE IN THE TREATMENT OF MILD TO MODERATE HYPERTENSION: DR. REDDY’S LABORATORY AN EXTENSION OF PROTOCOL AML-02-001/EXT

A randomized , double blided, double dummy, parallel group, multi - center study to investigate the time of onset of action of 10mg and 20mg of vardenafil compared to placebo in males with erectile dysfunction.
BAYER

Prospective, open label non comparative, multi-center trial to evaluate the efficacy and safety of ciprofloxacin extended release (Cipro XR) 500 mg once daily for 3 days in the treatment of female patients with acute, uncomplicated, symptomatic, lower urinary tract infections. BAYER

A randomized, double-blind, parellel-group, placebo-controlled study evaluating the efficacy, saftey, and reliability,of 10mg vardenfil administered for 12 weeks compared to placebo in subjects with erectile dysfunction and a demonstrated successful first response to 10mg. BAYER/GLAXOSMITHKLINE

AN OPEN LABEL, RANDOMIZED STUDY TO EVALUATE THE SAFETY OF 4mg NICOTINE LOZEGES IN COMPARISON WITH 4 mg NICOTINE GUM IN SMOKERS WITH CERTAIN UNDERLYING DESEASE RESTRICTION SPECIFIED IN THE LABEL. GLAXOSMITHKLINE

A FOUR-ARM STUDY COMPARING THE ANALGESIC EFFICACY AND SAFETY OF TRAMADOL HCI ONCE A DAY 100, 200, AND 300 mg VERSUS PLACEBO FOR THE TREATMENT OF PAIN DUE TO OSTEOARTHRITIS OF THE KNEE. LABOPHARM

SAFETY AND EFFICACY OF HUMAN INSULIN INHALATION POWDER IN PATIENTS WITH TYPE 1 DIABETES MELLITUS. ELI LILLY

A Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Study to Evaluate the Safety and Efficacy of Rofecoxib 12.5 mg and Celecoxib 200 mg in Patients with Osteoarthritis of the Knee. MERCK

A multicenter, double blind, randomized, parallel group, 6 week study to evaluate the efficiacy and safety of ezetimibe/simvastatin combination tablets vesus atorvastatin in patients with hypercholesterolemia. MERCK

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE
PAGE FORTY-NINE

RESEARCH ACTIVITIES (CONTINUED):

A 12 week mulit-center, open-label forced titration study to investigate the efficacy and safety of valsartan (160mg), valsartan (320mg) and valsarton/hydrochlorothiazide (12.5mg) in the treatment of mild to moderate hypertensive subjects. NOVARTIS

A 12 week randomized, double- blinded, placebo, controlled multicenter study of the Analgestic efficacy of Celecoxib, 200 mg QD and 200 mg BID compared to Placebo in Patients with Chronic lower back pain. PFIZER

A 12 week double blinded, placebo - controlled, randomized, multicenter study with follow up evaluating the safety and efficacy of varenicline tartrate (CP 526, 555) in comparison to Zyban for smoking cessation. PFIZER

This study will be a multi-center, double blind, ransdomized, placebo controlled, parallel group design to investigate the efficacy, tolerability, and safety of a 60mg dose t.i.d. of orlistat in an overweight population with a BMI of >25 and <28. ROCHE

The Efficacy and safety of Avalide 150/12.5 MG and avalide 300/25 MG In Patients with hypertension uncontrolled on monotherapy. SANOFI-SYNTHELABO

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Outpatient, Safety an Efficacy Study of TAK-375 in Elderly Subjects with Chronic Insominia. TAKEDA

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Outpatient, Safety and Efficacy Study of TAK-375 in Adults with Chronic Insomnia. TAKEDA

A Multi-Center , Randonized, Double-Blind, Parallel Group, Placesbo-Controlled Study Of Efficacy And Safety Of Immune Modulation Therapy In Improving Waliking Distance In Patients With Intermittent Claudication Secondary To Peripheral Arterial Disease.

An 84 week extention to: a multicenter, double-blind, randomized, placebo-controlled study to evaluate the safety and efficacy of the addition of mk-0767 to patients with type 2 diabetes with inadequate glycemic control on combined metformin and sulfonylurea theraphy. merck

A RANDOMIZED, DOUBLE-BLIND, MULTICNTER, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF VALSARTAN (320 MG) AND HYDROCHLOROTHIAZIDE (12.5 AND 25 MG) COMBINED AND ALONE, VALSARTAN 160 MG AND VALSARTAN 160 MG/ HYDROCHLOROTHIAZIDE 12.5 IN HYPERTENSIVE PATIENTS. NOVARTIS

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE

PAGE FIFTY

RESEARCH ACTIVITIES (CONTINUED):

A DOULBLE-BLIND, RANDOMIZED, CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY EVALKUATING THE SAFETY AND EFFICACY OF CIVAMIDE CREAM 0.075% AS A TREATMENT IN SUBJECTS WITH OSTEOARTHRISIS OF THE KNEE. WINSTON
A Randomized Multicenter Double-Blind Study Comparing the Analgesic of Extended Release Hydrocodone/Acetaminophen (Vicodin CR) and Placebo in Subjects with Osteoarthritis. abbott

An Observational Study to Evaluate Patient Reported Outcomes in Subjects With and Without Premature Ejaculation. alza

A 6 week, Randomized, Open - Label, Comparative Study to Evaluate the Efficacy and Safety of Rosuvastatun and Atrovastatin in the Treatment of Hypercholesterolemia in Hispanic Subjects. astrazeneca

A phase III, multi-center, randomized. double-blind, placebo-controlled, parallel group factorial study of metoprolol succinat extended- release tablets (TOPROL-XL), hydrochlorothiazide and their combination in patients with essential hypertension. astrazeneca

A 6 week open label, randomised, multicenter, phase iiib, parallel group study to compare the efficacy and safety of rosuvastatin (10mg) with atrorvastatin (20mg) in subjects with hypersholesterolaemia and wither a history of coronary disease or clinical evidence of atherosclerosis or a CHD risk quivalent (10 year risk score of >20%) astrazeneca

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of AZD7371 in Patients 18-70 Years of Age with Symptoms of Overactive Bladder (GOBI STUDY). astrazeneca

A double-blind, randomized, parallel-group, placebo-controlled, multi-center study to compare the clinical equivalence of metronidazole topical gel USP, 0.75%-generic Atrix laboratories, Inc. and metronidazole topical gel 0.75% (Metrogel) in subjects with moderate to severe Acne Rosacea. atrix

The Efficacy and Safety of Irbesartan/HCTZ Combination Therapy as First Line Treatment for Severe Hypertension. bristol myers squibb

A prospective, randomised, open-label, blinded end-point, forced-titration trial to compare MICARDIS PLUS/ MICARDIS HCT (telmisatran combined with hydrochlorothiazide 80 mg/12.50mg) to DIOVAN HCT (valsartan combined with hydrochlorothiazide 160mg/12.50 mg), for the control of mild-to-moderate hypertension in overweight and obese patients with type-2 diabetes mellitus using ambulatory blood pressure monitoring. boehringer ingelheim

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE

PAGE FIFTY-ONE

RESEARCH ACTIVITIES (CONTINUED):

A randomised, double blinded, double dummy, placebo-controlled, forced titration, comparison of MICARDIS HCT verses DIVAN HCT using seated
trough cuff blood pressure in patients with stage 1 and stage 2 hypertension. boehringer ingelheim

The Efficacy and Safety of Irbesartan/HCTZ Combination Therapy as First Line Treatment for Patients with Moderate Hypertension. bristol myers squibb

A Multicanter, Randomized, Double-Blinded, Active Comparator Study to Determine the Efficacy and Safety of BTDS 20 or OxyIR versus BTDS 5 in Subject with Moderate to Severe Low Back Pain. purdue pharmaceutical

A double blinded, randomized, placebo controlled phase III safety study of tramadol ER 300 MG, taken once dailyfro the relief of signs and symptons of osteoarthritis of the hip and knee. CIPHER

A Phase III Pivotal, Multi-Center, Double-Blind, Randomized, Placebo-Controlled Mono-Therapy Study of Milnacipran for Treatment of Fibromyalgia. CYPRESS PHARMACEUTICALS

An Open-Label Titration Followed by a Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Tolerability, and Safety of Oxymorphone Extended Release Tablets in Opoid-Naive Patients with Chronic Low Back Pain. ENDO PHARMACEUTICAL

A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE SAFETY AND EFFICACY OF ROSIGLITAZONE MALEATE IN THE TREATMENT OF CHRONIC PLAGUE PSORIASIS. GLAXO-SMITHKLINE

A Randomized, Double-Blind, Placebo-Controlled, Multicenter 60-Day Study Comparing the Efficacy of Valtrex 1 Gram Once Daily vs. Placebo Once Daily in Reducing Viral Shedding in Immunocompetent Subjects with Recurrent HSV-2 Genital Herpes. GSK

A randomized, double-blind, crossover study to evaluate the duration of erection following Vardenafil (10mg) administration for 4 weeks in fixed-dose regimen compared to placebo in males with ED. GSK

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE

PAGE FIFTY-TWO

RESEARCH ACTIVITIES (CONTINUED):

A multi-center, randomized, parallel-group, active-controlled, double-blind Study Conducted Under In-house Blinding Conditions to Determine the Incidence of Gastroduodenal Ulcers in Patients With Osteoarthritis or Rheumatoid Arthritis After 12 Weeks Of Treatment With L-001069957 21 mg Plus Low-Dose Aspirin, L-001069957 42mg PLus Low-Dose Aspirin, Celecoxib 400mg Plus Low-Dose Aspirin, or Low-Dose Aspirin Alone. MERCK

A study to Assess the safety and Efficacy of L-0008990055 in Obese Patients. MERCK

A double blind, randomized, placebo controlled, multicenter study to assess the safety, tolerability and efficacy of L000753721 in obese patients. MERCK

A Multicenter, Randomized, Double-Blind Study to Evaluate to Lipid-Altering Efficacy and Safety of the Ezetimibe/Simvastatin Combination Tablet Versus Rosuvastatin in Patients With Primary Hypercholesterolemia. MERCK

A 26-Week, Randomized, Placebo- and Active-Comparator-Controlled, Parellel-Group, Double-Blind, 2-Part Study to Assess the Safety and Efficacy of Etoricoxib 30 mg Versus Celecoxib 200 mg in Patients With Osteoarthritis (Study 1)." (MK0663- Protocol 076) EXCCEL I. MERCK

A randomized, double blind, placebo controlled multicenter study to access the efficacy, safety and tolerablility of tefaserod alone and in combination with omeprazole given orally in patients suffering from symptomatic (non-erosive) gastroesophageal reflux disease. NOVARTIS

A randomized, double-blind, placebo-controlled, multicenter evaluation of the efficacy and safety of tegaserod (6 mg b.i.d.), administered orally for 12 weeks, to male patients with chronic constipation. NOVARTIS

A 12 week, randomized, double blind, placebo-controlled, parallel group, mulitcenter study to evaluate the efficacy of Enablex (Darifenacin) 15 mg OD on increase in warning time, the time from sensation of urgency to voiding, in patients with overactive bladder. NOVARTIS

A 10-week, multi-center withdrawal design pilot study of the role of tegaserod 6 mg b.id. add-on therapy in the management of GERD symptoms in patients with incomplete response to Proton Pump Inhibitors (PPIs). NOVARTIS

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE

PAGE FIFTY-THREE

RESEARCH ACTIVITIES (CONTINUED):

A randomized, double-blind, multicenter, positive-controlled, parallel group study to evaluate the safety and efficacy of amlodipine and benazepril administered in combination compared to amlodipine monotherapy in hypertensive patients not adequately controlled with amlodipine alone. NOVARTIS

An 8 week double-blind, multicenter, randomized, multifactorial, placebo-controlled, parallel-group study to evaluate the efficacy and safety of aliskiren administerd alone and in combination with hydrochlorothiazide in patients with essential hypertension. NOVARTIS

A randomized, double blinded, multicenter, placebo-controlled, parallel group study tp evaluate the efficacy and safety of valsartan and hydrochlorothiazide combined and alone, valsartan 160mg and valsartan 160 mg/ hydrochlorothiazide 12.5 mg in hypertensive patients. NOVARTIS

A 12-week, randomized, double-blind, multi-center, vehicle-coontrolled, parallel group study to assess the efficacy and safety of the Diclofenac Sodium Gel 1% for the relief of signs and symptoms in patients with osteoarthritis of the knee. NOVARTIS

A Double-Blind, Randomized, Placebo Controlled, Parallel Group, Multi-Site Study to Compare the Clinical Equivalence of Fluticasone Nasal Spray (Teva Pharmaceuticsl, USA) with Flonase Nasal Spray (GSK) in the Relief of the Signs and Symptoms of Seasonal Allergic Rhinitis. NOVUM

A phase 2 safety and efficacy study to NPS 1776 for the acute migraine.
NPS PHARMACEUTICALS

An Open-Label Evaluation of the Safety and Efficacy of a Combination of Niacin ER and Simvastatin in Patients with Dyslipidemia. (High Cholesterol). KOS

Double blinded, placebo controlled, parallel group study to evaluate the Efficacy and safety of Tramadol HCI/Acetaminophen for the treatment of painful Diabetic Neuroppathy. ORTHOL-MCNEIL

A Multicenter, double blinded, active and placebo controlled efficancy and safety study of oxycodone HCI and low dose Naltrexone HCI in patient with low back pain. PAIN THERAPEUTICS

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose, Parallel-Group Study Comparing the Safety and Effectiveness of Petoprolol Tartrate Extended-Release Tablets 25mg Once Daily Versus Placebo Using 24-Hour Ambulatory Blood Pressure Monitoring In Patients With Stage I to Stage II Hypertension. PENWEST

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE

PAGE FIFTY-FOUR

RESEARCH ACTIVITIES (CONTINUED):

A Randomized, Double-Blind, Parallel Group Study Comparing the Efficacy and Safety of Certirizine HCI (Zertec) 10Mg Daily vs. Placebo in Subjects Who Have Used Fexofenadine HCI (Allegra) 180Mg Daily to Treat Their Allergic Rhiniti's Symptoms. PFIZER

A double blinded, placebo controlled study of the efficacy and tolerablility of once daily celebrex vs placebo in the treatment of the knee non-responsive to Naproxen and Ibuprofen. PFIZER

Symptom Specific Effectiveness of Tolterodine ER 4mg in Patients with Symptoms of Overactive Bladder (OAB) in a Primary Care Setting. A phase IV, Open-Label, Single Arm, Non-Randomized Trial in Adult Patients with OAB." PFIZER

A 6-Month, Randomized Study to Evaluate the Efficacy and Cost Effectiveness of Various Non-Pharmacologic, Disease Management Programs For the Treatment of Obesity. PFIZER

Randomized, open -label, multi-center study to investigate patient preference on dosing in women with postmenopausal osteoporosis treated with once-monthly ibandronate and once-weekly alendronate.A six-month, two-sequence, and two-period crossover study. ROCHE

A prospective, Open -Label, Tritation Study to Assess the Efficacy and Safety of Benicar and Benicar/HCT in Patients with Stage II Systolic Hypertension. SANKYO

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of WelChol in Type 2 Diabetics with Inadequate Glycemic Control on Metformin Monotherapy. SANKYO

A mutli-center, randomized, double-blinded, lacebo-controlled, parallel-group study of the efficacy and safety of welchol in type 2 diabetics with inadequate glycemic control on Metformin Monotherapy. SANKYO

The Efficacy and safety of Avalide 150/12.5 MG and avalide 300/25 MG In Patients with hypertension uncontrolled on monotherapy. SANOFI-SYNTHELABO

LARRY I. GILDERMAN, D.O.
CURRICULUM VITAE

PAGE FIFTY-FIVE

RESEARCH ACTIVITIES (CONTINUED):

A multi-center, randomized, double-blind, placebo-controlled dose finding trial to asses the efficacy and safety of 200,400, and 600 MG/Day of SPM 927 in subjects with painful Distal Diabetic Neuropathy. SCHWARTZ BIOSCIENCE.

A phase 3, parallel group, randomized, double blinded, placebo controlled, multicenter trail to investigate the efficacy, tolerability and safety of fesoterodine sustained release in subjects with overactive bladder syndrome. SCHWARTZ BIOSCIENCE

A Multi-Center, Open-Label, Follow-On Trial To Assess The Safety and Efficacy of SPM 927 in Subjects With Painful Distal Diabetic Neuropathy. SCHWARTZ BIOSCIENCE

A six month study, chronic efficacy and safety of Eszopiclone in adult subjects with primary insomnia: A randomized, double blinded, placebo controlled study. SEPRACOR

The Efficacy of Eszopiclone 3 mg Compared to Placebo in the Treatment of Insomnia Secondary to Perimenopause or Menopause. SEPRACOR

A Phase II, Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study of the Efficacy, Safety, and Toleraility of Takeda-536 in Patients with Mild to Moderate Uncomplicated Essential Hypertension. TAKEDA

A Phase II, Double-Blind, Randomized, Placebo-Controlled, Proof-of-Concept Study of the Efficacy, Safety and Tolerability of Pioglitazone HCI (ACTOS) in combination with TAK-536 in Subject with Type 2 Diabetes". TAKEDA

A randomized double blind phase 3 study to compare the efficacy and safety of Lansoprazole 30mg QD and Naproxan 500mg versus BID Celecoxib 200mg QD in the risk reduction of Non-steroidal anti-inflammatory-associated ulcer in Osteoarthritis subjects taking low dose aspirin.
TAP PHARMACEUTICAL

A Multi-Center , Randonized, Double-Blind, Parallel Group, Placesbo-Controlled Study Of Efficacy And Safety Of Immune Modulation Therapy In Improving Waliking Distance n Patients With Intermittent Claudication Secondary To Peripheral Arterial Disease. VASOGEN

A Double Blinded, Randomized, Controlled, Parallel-Group, multicenter study evaluating the safety and efficacy of civamide cream .075% as a treatment in subjects with osteoarthritis of the knee. WINSTON

An Open Label Multicenter Study Evaluating the Safety of Civamide Cream 0.075% as a Treatment in Subjects with Osteoarthritis of the Knee. WINSTON

LARRY I. GILDERMAN, D.O.
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Sympton Relief suffering from gastoesophagela reflux disease grade A to D according o Los Angeles (LA) classification treated with Pantoprazole 40 MG QD or Esomeprazole 40 MG QD. WYETH

SAFETY and EFFICACY EVALUATION OF COL-RA™ GEL, 0.05% VERSUS RETIN-A® MICRO, 0.1% AND COL-ra™ GEL VEHICLE IN THE TREATMENT OF MILD TO MODERATE ACNE VULGARIS. HEALTHPOINT, LTD.

A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, VEHICLE-CONTROLLED STUDY OF THE SAFETY AND EFFICACY OF CLINDAMYCIN PHOSPHATE FOAM, 1% VERSUS CLINDAGEL (CLINDAMYCIN PHOSPHATE GEL) TOPICAL GEL, 1% FOR THE TREATMENT OF ACNE VULGARIS. cONNETICS.

A randomized, double-blind, placebo-controlled, forced-titration, Phase IV study comparing telmisartan 80 mg + hydrochlorothiazide 25 mg versus valsartan 160 mg + hydrochlorothiazide 25 mg taken orally for 8 weeks in patients with Stage 1 or Stage 2 hypertension. Boehringer Ingelheim

APD356-004: “A 12-Week, Dose-ranging, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety and Efficacy of APD356 in Obese Patients.” Arena

A double blind, placebo-controlled study of Rabeprazole 20 mg maintenance intermittent therapy following acute treatment in patients with symptomatic Gastroesophageal Reflux Disease. Eisai

A Phase II Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of a Four-Week Treatment with ATI-7505 for the Healing of Acute Erosive Esophagitis. Aryx Therapeutics.

A Phase II Randomized, Double-Blind, Placebo Controlled, Parallel Group, Multicenter Study to Evaluate the Efficacy and Safety of a Four-Week Treatment with ATI-7505 for the Relief of
Heartburn Symptoms in Patients with Symptomatic Gastro-Esophageal Reflux Disease (GERD). Aryx Therapeutics.

MAXAQUIN TREATMENT OF CHRONIC BRONCHITIS: EFFICACY IN PATIENTS WHO ARE CIGARETTE SMOKERS. L.I.GILDERMAN, D.O.; M.E. KUSS; M.J. KELLY, M.S. UNIVERSITY CLINICAL RESEARCH ASSOCIATES, INC., 1150 NORTH UNIVERSITY DRIVE, PEMBROKE PINES, FLORIDA 33024.

EFFICACY OF MAZAQUIN IN TREATING CHRONIC BRONCHITIS: STUDIES IN THE ELDERLY vs. CEFACLOR. L.I.GILDERMAN, D.O.; M.E.KUSS; M.J.KELLY, M.S. UNIVERSITY CLINICAL RESEARCH ASSOCIATES, INC., 1150 NORTH UNIVERSITY DRIVE, PEMBROKE PINES, FLORIDA 33024.

MAXAQUIN EFFICACY IN TREATMENT OF CHRONIC BRONCHITIS: RESULTS OF STUDIES IN THE ELDERLY POPULATION. L.I.GILDERMAN, D.O.; B.RONIKER, M.D.; M.E.KUSS; M.J.KELLY, M.S. UNIVERSITY CLINICAL RESEARCH ASSOCIATES, INC., 1150 NORTH UNIVERSITY DRIVE, FLORIDA 33024.

LARRY I. GILDERMAN, D.O.
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MAXAQUIN THERAPY IN THE TREATMENT OF CHRONIC BRONCHITIS: SAFETY AND EFFICACY IN PATIENTS CONCOMITANTLY TREATED WITH THEOPHYLLINE. L.I.GILDERMAN, D.O.; M.E.KUSS; M.J.KELLY, M.S. UNIVERSITY CLINICAL RESEARCH ASSOCIATES, INC., 1150 NORTH UNIVERSITY DRIVE, PEMBROKE PINES, FLORIDA 33024.

EFFICACY OF MAXAQUIN IN TREATING BRONCHITIS: RESULTS OF COMPARATIVE STUDIES vs. AMOXICILLIN AND CEFACLOR. L.I.GILDERMAN, D.O.; R.RONIKER, M.D.; M.E.KUSS, UNIVERSITY CLINICAL RESEARCH ASSOCIATES, INC., 1150 NORTH UNIVERSITY DRIVE, PEMBROKE PINES, FLORIDA 33024.

TREATMENT OF ISOLATED SYSTOLIC HYPERTENSION WITH LABELATOL IN THE ELDERLY. THOMAS D. GILES, M.D.; MICHAEL WEBER, M.D.; DAVID W. BARTELS, PHARM D.; HAROLD M. SILBERMAN, N.S.; LAWRENCE I. GILDERMAN, D.O.; JAMES F. BURRIS, M.D.

CEFPROZIL vs. CEFUROXIME AXETIL IN MILD TO MODERATE LOWER RESPIRATORY TRACT INFECTION. CEFPROZIL MULTI-CENTER STUDY GROUP. DR. BONNET; DR. GINSBERG; DR. NOLEN; DR. ALWINE; DR. ROSIELLO; DR. PAPPAS; DR. WEISMAN; DR., GILDERMAN; DR. PAUL.

EFFICACY AND TOLERABILITY OF EXTENDED RELEASE FELODIPINE AND EXTENDED-RELEASE NIFEDIPINE IN PATIENTS WITH MILD TO MODERATE ESSENTIAL HYPERTENSION. TIMOTHY C. FAGAN, M.D.; BRIAN E. HAGGERT, M.S; CHARLES LISS, M.S.; LARRY I. GILDERMAN, D.O.

QUALITY OF LIFE AND ANTIHYPERTENSIVE THERAPY IN MEN. A COMPARISON OF CATOPRIL WITH ENALAPRIL. M.A. MOORE; J.E. ANGELO; L.I. GILDERMAN, D.O.; ET AL.

BLOOD PRESSURE CONTROL WITH DILTIAZEM XR. A NOVEL EXTENDED RELEASE FORMULATION OF DILTIAZEM HCL IN MATURE AND ELDERLY HYPERTENSIVE PATIENTS. AMERICAN JOURNAL OF CLINICAL THERAPEUTICS, VOLUME 16., NUMBER 2. PRESENTED AT AMERICAN SOCIETY OF HYPERTENSION - REPRINTED FROM THE NEW ENGLAND JOURNAL OF MEDICINE 328:907-913 (APRIL 1), 1993.

EFFICACY AND SAFETY OF THE NEURAMINIDASE INHIBITOR ZANAMIVIR IN THE TREATMENT OF INFLUENZAVIRUS INFECTIONS. THE NEW ENGLAND JOURNAL OF MEDICINE, SEPTEMBER 25, 1997.

SAFETY AND EFFICACY OF MELOXICAM IN THE TREATMENT OF OSTEOARTHRITIS (OA): A 12-WEEK, DOUBLE-BLIND, MULTIPLE DOSE, PLACEBO CONTROLLED TRIAL. ARCHIVES OF INTERNAL MEDICINE, VOLUME 160, OCTOBER 23, 2000.

DULOXETINE VERSUS PLACEBO IN THE TREATMENT OF STRESS URINARY INCONTINENCE. THE AMERICAN JOURNAL OF OBSTETRICS AND GYNECOLOGY. 2001

PHARMACODYNAMIC DISSECTION OF DOSE-RESPONSE TO MELOXICAM IN OSTEOARTHRITIS USING THE WOMAC INDEX. POSTER AT THE ILAR CONGRESS OF IMMUNOLOGY IN EDMONTON, ALBERTA, CANADA

LARRY I. GILDERMAN, D.O.
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RESEARCH ACTIVITIES (CONTINUED):

LOSARTAN VERSUS VALSARTAN IN THE TREATMENT OF PATIENTS WITH MILD TO MODERATE ESSENTIAL HYPERTENSION: DATA FROM A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, 12-WEEK TRIAL. CLINICAL THERAPEUTICS. THE INTERNATIONAL PEER-REVIEWED JOURNAL OF DRUG THERAPY, AUGUST 2001.

ANTI-FLAMMATORY AND UPPER GASTROINTESTINAL EFFECTS OF CELECOXIB IN RHEUMATIOD ARTHRITIS A RANDOMIZED CONTROLLED TRIAL. JAMA, VOL. 282, NO. 20, NOVEMBER 24, 1999.

CYCLOOXYGENASE-2-SPECIFIC INHIBITORS AND CARDIORENAL FUNCTION: A RANDOMIZED, CONTROLLED TRIAL OF CELECOXIB AND ROFECOXIB IN OLDER HYPERTENSIVE OSTEOARTHRITIS PATIENTS. LIPPINCOTT WILLIAMS & WILKINS, INC., 2001.

PA NORTON, NR ZINNER, I YALCIN, RC BUMP FOR THE DOULOXETINE UI STUDY GROUP. DULOXETINE VERSUS PLACEBO IN THE TREATMENT OF STRESS URINARY INCONTINENCE. AM J OBSTET GYNECOL 2001;186

EFFICACY AND SAFETY OF A ONCE DAILY GRADED-RELEASE DILTIZEM FORMULATION IN ESSENTIAL HYPERTENSION. AMERICAN JOURNAL OF HYPERTENSION; JAN. 2003, VOL. 16, NO. 1

CASTELL DO, KAHRILAS PJ, RICHTER JE, VAKIL NB, JOHNSON DA, ZUCKERMAN S, SKAMMER W, LEVINE JG, ESOMIPRAZOLE (40 MG) COMPARED WITH LANSOPRAZOLE (30 MG) IN THE TREATMENT OF EROSIVE ESOPHAGITIS. AMERICAN JOURNAL OF GASTROENTEROLOGY; 2002:97 (3): 575-583.

ASSESSMENT OF THE ASSOCIATION BETWEEN BLOOD PRESSURE CONTROL AND HEALTH CARE RESOURCE USE. CLINICAL THERAPEUTICS; VOL. 23, NO. 10, 2001.

A DOUBLE-BLIND, RANDOMIZED, PARALLEL, PLACEBO-CONTROLLED, EFFICACY STUDY OF LOSARTAN POTASSIUM 100 mg- HYDROCHOLROTHIAZIDE 25 mg VERSUS LOSARTAN POTASSIUM 50 mg-HYDROCHOLROTHIAZIDE 12.5 mg IN PATIENTS WITH ESSENTIAL HYPERTENSION.” MERCK CLINICAL THERAPEUTICS: VOL. 24, NO. 7, 7,2002

ESOMEPRAZOLE (40 MG) COMPARED WITH LANSOPRAZOLE (30 mg) IN THE TREATMENT OF EROSIVE ESOPHAGITIS. THE AMERICAN JOURNAL OF GASTROENTEROLOGY; VOL. 97, NO. 3, 3/2002.

A 52 WEEK, DOUBLE BLIND, RANDOMIZED, PLACEBO CONTROLLED, MULTICENTER TRIAL TO EVALUATE THE EFFICACY OF ORLISTAT PLUS DIET IN OBESE HYPERTENSIVE PATIENTS INADEQUATELY CONTROLLED WITH ANTIHYPERTENSIVE MEDICATIONS. JOURNAL OF HYPERTENSION; VOL. 20, NO. 11, 12/2002.

LARRY I. GILDERMAN, D.O.
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RESEARCH ACTIVITIES (CONTINUED):

TREATMENT OF MIGRAINE AT THE FIRST SIGN OF PAIN: PROSPECTIVE, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDIES OF SUMATRIPTAN 50MG AND 100MG VERSUS PLACEBO. MAYO CLINICAL PROCEEDINGS

Efficacy and safety of a once daily graded-release dilitiazem formulation i essential hypertensio; american journal of hypertension vol. 16, no. 1

EFFICACY AND SAFETY OF ORAL PLECONARIL FOR TREATMENT OF COLDS DUE TO PICORNAVIRUSES IN ADULTS: RESULTS OF 2 DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED TRIALS.CLINICAL INFECTIOUS DISEASES 2003; 36:1523-32 June 15

VARDENAFIL FOR TREATMENT OF MEN WITH ERECTILE DYSFUNCTION: EFFICACY AND SAFETY IN A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED TRAIL; JOURNAL OF ANDROLOGY, VOL.3; NO.6; DEC. 2002

A MULTICENTER, RANDOMIZED STUDY OF AN EXTENDED CYCLE ORAL CONTRACEPTIVE; ELSEVIER VOL. 68 NO. 2; AUGUST 2003

Efficacy and safety of a once daily graded-release diltiazem formulation in essential hypertension; AMERICAN JOURNAL OF HTN; VOL. 16, NO. 1, JAN. 2003

ANTIHYPERTENSIVE EFFICACY OF ADDING CANDESARTAN CILEXTIL TO LISINOPHIL IN COMPARISON TO UP-TITRATION OF LISISNOPRIL. SCIENTIFIC CONNEXTIONS

Efficacy and safety of a once daily graded-release diltiazem formulation in essential hypertension; American journal of htn vol. 16, no. 1, jan. 2003

A multicenter, randomized study OF AN EXTENDED CYCLE ORAL CONTRACEPTIVE; CONTRACEPTION VOL. 68, NO. 2, AUG. 2003

COMPARISON OF THE EFFICACY AND SAFETY OF ROSUVASTATIN VERSUS ATORVASTATIN, SIMVASTATIN, AND PRAVASTATIN ACROSS DOSES (STELLAR TRAIL); AMERICAN JOURNAL OF CARDIOLOGY VOL. 92, JULY 2003

ANTIHYPERTENSIVE EFFICACY AND SAFETY OF OLMESARTAN MEDOXOMIL COMPARED WITH AMLODIPINE FOR MILD TO MODERATE HYPERTENSION; JOURNAL OF HUMAN HTN, VOL. 17, NO. 6, JUNE 2003

Randomized, placebo-controlled trial of 7747 adults with previous mucocardial that had occurred at least 6 weeks previously (median, 2.6 ears) and a C PNEUMONIAE 1gG TITER OF 1:16 OR MORE. PATIENTS WERE RECRUITED FROM 271 CLINICAL PRACTICES IN NORTH AMERICA, EUROPE, ARGENTINA, AND INDIA FROM OCTOBER 10, 1997 TO JULY 22, 2001. AMERICAN MEDICAL ASOCIATION SEPT. 17, 2003; VOL. 290, NO. 11

LARRY I. GILDERMAN, D.O.
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RESEARCH ACTIVITIES (CONTINUED):

Comparison of the efficacy of rosuvastatin versus atorvastatin, simvastatin, and pravastatin in achieving lipid goals; results from the stellar trial. cmrojournal; vol. 19; no. 8; 2003

Azithromycin for the Secondary prevention of coronary heart disease events; the wizard study: a randomized controlled trial. aMERICAN medical assoc. sept. 17, 2003- vol. 290, no. 11

EFFICACY AND SAFETY OF EZETIMIDE C-ADMINISTERED WITH SIMVASTATIN COMPARED WITH ATORVASTATIN IN ADULTS WITH HYPERCHOLESTEROLEMIA; THE AMERICAN JOURNAL OF CARDIOLOGY; JUNE 15, 2004 VOL.93

ANTIHYPERTENSIVE EFFICACY OF CANDESSARTAN-LISINOPRIL IN COMBINATION VS. UP-TITRATION OF LISINOPRIL: THE AMAZE TRIALS; THE JOURNAL OF CLINICAL HYPERTENSION VOL.VI NO.IX SEPTEMBER 2004

V211-010-00: A Double-Blind, Randomized, Controlled, Multicenter Study to Evaluate the Safety, Tolerability and Immunogenicity of a Refrigerator-Stable Formulation of Zoster Vaccine Live (Oka/Merck)

A Randomized, Double-Blind, Placebo Controlled Trial to Evaluate the Efficacy of FluviralÔ Influenza Vaccine in Healthy Adults 18-49 Years of Age/ IDB-707-106 IDBiomedical

Novartis Pharmaceuticals trial entitled: A 28-week, multicenter, randomized, active controlled, parallel group study to evaluate the effects of Diovan HCT® (160/12.5 mg) in comparison with hydrochlorothiazide (25 mg) monotherapy, for the treatment of patients with hypertension, uncontrolled by hydrochlorothiazide (12.5 mg) monotherapy

Protocol Number 01-04-TL-475-008: A Double-Blind, Randomized Study to Evaluate the Efficacy and Safety of TAK-475 100 MG Versus Placebo in Subjects with Primary Hypercholesterolemia.

Protocol Number 01-04-TL-475-009: A Double-Blind, Randomized Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-475 (50 MG or 100 MG) when Co-Administered with Atorvastatin (10 MG to 40 MG) in Subjects with Primary Hypercholesterolemia.

An Open-Label Extension Study to Evaluate the Safety and Tolerability of TAK-475 100 mg in Subjects with Primary Hypercholesterolemia or Combined Hyperlipidemia; Protocol number 01-04-TL-475-010.

D9612L00084 - An Investigation of the Prevalence of Clinically Relevant Esophageal Mucosal Pathology (EMP) in Users of Prilosec OTC, AstraZeneca

LARRY I. GILDERMAN, D.O.
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RESEARCH ACTIVITIES (CONTINUED):

ID Biomedical, “A Non-Inferiority Comparison of Fluviral™ Influenza Virus Vaccine to a U.S. Licensed Inactivated Split-Virion Vaccine (Fluzone®) in Adults ≥ 50 Years Old Living in the Community”

PROTOCOL H-040-010:
RANDOMISED, DOUBLE BLIND, MULTICENTRE, PLACEBO CONTROLLED PHASE III STUDY OF THE SAFETY AND TOLERABILITY FOLLOWING ADMINISTRATION OF LIVE ATTENUATED JE VACCINE (ChimeriVax™-JE)

ACZ ACN 01 – A Phase 4, Double-Blind, Multicenter, Randomized, Vehicle-Controlled, Cross-Over Study to Further Evaluate the Risk of Hematological Adverse Events in G6PD-Deficent Subjects with Acne vulgaris Treated with ACZONETM (Dapsone) Gel, 5%

A Phase II, Multi-center, Randomized, Double-Blind, Placebo Controlled Trial of VLTS-934 in Subjects with Intermittent Claudication Secondary to Peripheral Arterial Disease. Protocol Number: VLTS-934-123

SB-480848/LPL104884
LPL104884: A multicenter, randomized, double-blind, placebo-controlled, parallel-group, dose-ranging study of SB-480848, an oral lipoprotein-associated phospholipase A2 (Lp-PLA2) inhibitor, in subjects with stable coronary artery disease (CHD) or CHD-risk equivalent to examine chronic inhibition of Lp-PLA2 effects on circulating biomarkers associated with cardiovascular risk, safety and tolerability over 12 weeks

TRX103635: A randomized, double-blind, multi-center, placebo-controlled, cross-over study to determine the consistency of response for Trexima™ (sumatriptan, 85mg/naproxen sodium 500mg) administered during the mild pain phase for the acute treatment of multiple migraine attacks

Protocol Number: E3810-A001-312
Efficacy and Safety of 10 mg Rabeprazole for Treating Heartburn in Frequent Sufferers.

IND# - 33,985

A Phase 3, Randomized, Multicenter, Double-Blind Study Comparing the Analgesic Efficacy of Extended Release Hydrocodone/Acetaminophen Tablets (Vicodin® CR) to Placebo in Subjects with Osteoarthritis. Abbott

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of L-001104330 and L-00414380 in Hypertensive. Merck

ACZ ROS 01 – A Phase II, Randomized, Partial-Blind, Parallel-Group, Active- and Vehicle-Controlled, Multicenter Study of the Safety and Efficacy of ACZONETM (Dapsone) Gel, 5% in Subjects With Papulopustular Rosacea

LARRY I. GILDERMAN, D.O.
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Grunenthal GmbH Protocol KF0151Y/07:

A randomized, multi-center, double blind, parallel-group study assessing the analgesic efficacy and safety of different dosages of GRT0151Y bid compared to active comparator bid and placebo bid in subjects with chronic knee-joint osteoarthritis.

SK&F-105517/COR103561

A Randomized, Double-Blind, Multi-Center Study Comparing the Effects of Carvedilol Phosphate Modified Release Formulation (COREG-MR) with Metoprolol Succinate (Toprol-XL) on the Lipid Profile in Normolipidemic, or Mildly Dyslipidemic Hypertensive Patients.

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of MK-0736 and MK-0916 in Hypertensive Patients
Protocol No.: 003

A Randomized, Double-Blind, Placebo Controlled, Parallel Design, Multiple-Site Study to Evaluate the Clinical Equivalence of Two Ketoconazole 2% Shampoos in Patients with Tinea (Pityriasis) Versicolor
Protocol 70515013. Novum

A Multi-center, Randomized, double-Blind, “Factorial” Design study to Evaluate the Lipid-Altering Efficacy and Safety of MK-0524B Combination Tablet in Patients with Primary Hypercholesterolemia and Mixed Hyperlipidemia. Merck

Protocol 022

Protocol DR-CEN-302

A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Compare the Effects of 12 Weeks of Treatment with CenestinÔ Vaginal Cream vs. Placebo Vaginal Cream on Vulvovaginal Atrophy in Healthy Postmenopausal Women

A Multi-Center, Double-Blind, Placebo-Controlled Randomized Study of Bicifadine 200 mg BID, Bicifadine 400 mg BID, and Bicifadine 400 mg TID in the Treatment of Chronic Low Back Pain

DOV-075-021-US

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RESEARCH ACTIVITIES (CONTINUED):

A Multicenter, Randomized, Double-Blind, Prospective Study Comparing the Safety and Efficacy of Fenofibric Acid and Atorvastatin Calcium Combination Therapy to Fenofibric Acid and Atorvastatin Calcium Monotherapy in Subjects with Mixed Dyslipidemia. ABBOTT

Protocol number: M05-750

A Long-Term, Open-Label, Safety Extension Study of the Combination of Fenofibric Acid and StatinTherapy for Subjects with Mixed Dyslipidemia. ABBOTT

Protocol number: M05-758

Protocol: MCC-257/A03
A Phase II, Randomized, Double-Blind, Placebo-Controlled, 24-Week Dose Finding Study to Evaluate the Efficacy and Safety of 20 mg, 40 mg and 80 mg of MCC-257 in Patients with Mild to Moderate Diabetic Polyneuropathy

(PTI-821-CM)
A Long-Term, Open-Label, Safety Study of PTI-821 in Patients with Moderate to Severe Chronic Low Back Pain or with Moderate to Severe Chronic Pain Due to Osteoarthritis of the Hip or Knee.
Pain Therapeutics

(PTI-821-CO)
A Multi-Center, Randomized, Double-Blind, Placebo-Controlled, Phase III, Effucacy & Safety Study of PTI-821 in Patients with Moderate to Severe Chronic Pain Due to Osteoarthritis of the Hip or Knee.
Pain Therapeutics

Protocol 315-00: “A Double-Blind, Randomized, Parallel, Efficacy Study Evaluating Losartan Potassium Alone or in Combination with Hydrochlorothiazide versus Placebo in Obese Patients with Elevated Systolic and Diastolic Blood Pressure”.

Novartis Pharmaceuticals trial entitled: “A 36 week randomized, double-blind, parallel group, multicenter, active-controlled, optional titration study comparing an aliskiren-based regimen to a lisinopril-based regimen in patients ≥ 65 years old with systolic essential hypertension”
Protocol No.: CSPP100A2344

Protocol CFAM810A2308: A multicenter, randomized, double-blind study to compare the efficacy and safety of patient-initiated famciclovir 1000 mg b.i.d. x 1 day to valacyclovir 500 mg b.i.d. x 3 days in immunocompetent adults with recurrent genital herpes. Novartis

LARRY I. GILDERMAN, D.O.
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RESEARCH ACTIVITIES (CONTINUED):

Protocol Number: 81-0046

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Gabapentin Extended Release (G-ER) Tablets in the Treatment of Patients with Painful Diabetic Peripheral Neuropathy

RN624-CL006: A Randomized, Parallel Arm, Placebo-Controlled, Double-Blind, Multiple- Dose Study of the Safety and Efficacy of RN624 in Adults with Moderate-to-Severe Pain due to Osteoarthritis of the Knee

Prospective, Randomized, Double-Blind (Phase 3) Study of Rifalazil Treatment On the Number of Vascular Interventions and Peripheral Vascular Disease Endpoints in Chlamydia Pneumoniae Seropositive Patients (PROVIDENCE-1)

Protocol #ABI-1648-022

HTN-001
A Phase 2, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Study of the Effects of 6R-BH4 on Blood Pressure in Subjects with Poorly Controlled Systemic Hypertension

LEV106718 A randomized, double-blind, placebo-controlled, parallel-group, study evaluating the efficacy, safety, and duration of erection of flexible-dose vardenafil administered for 12 weeks compared to placebo in subjects with erectile dysfunction and dyslipidemia

CFD105453: A Randomized, Double-Blind, Double-Dummy, Parallel Group, Factorial Design Trial to Assess the Efficacy and Safety of up to Six Weeks Treatment with 20mg, 40mg, or 80mg QD Doses of Carvedilol Controlled Release Formulation (COREG CR) or 10mg, 20mg, or 40mg QD Doses of Lisinopril (Zestril) or a Combination of One of the Doses of Each Medication

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential-Design Study to Evaluate the Lipid-Altering Efficacy and Tolerability of MK-0354 in Patients with Dyslipidemia
Protocol 004

PRSW-GN-302: A Phase III, multi-center, randomized, double-blind, placebo-controlled, parallel group trial of fourteen day treatment with lansoprazole 15 mg once a day in frequent heartburn

NKB105022 A Twelve-Week Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Forced Titration, Proof of Concept Study to Assess the Efficacy, Safety and Tolerability as well as the Pharmacokinetic Profile of 60 mg and 120 mg of GW679769 administered once daily vs Placebo in Women with Overactive Bladder

A Double-Blind, Placebo-Controlled Study of Ketasyn™ (AC-1202) Administered for Ninety Days in Subjects with Age-Associated Memory Impairment (KET-06-003)

MA19547: Randomized, open-label, multi-center study to investigate patient preference on dosing in women with postmenopausal osteoporosis treated with once-monthly ibandronate and once-weekly risedronate. A six-month, two-sequence, and two-period crossover study.

Double-blind, double-dummy, randomized, parallel group trial of SL650472 (three dose regimens versus placebo and cilostazol), for 24-week improvement of walking distance in patients with stage II peripheral arterial disease who benefit from optimal prevention strategy including clopidogrel.

Protocol 023 - A Worldwide, Multicenter, Double-Blind, Randomized, Parallel Study to Evaluate the Efficacy of MK-0524 to Improve Tolerability of Extended Release Niacin

R331333-PAI-3004 A Randomized, Double-blind, Active Control, Parallel Arm, 90 Day Safety Study of CG5503 Immediate Release (IR) or Oxycodone IR in Subjects With Chronic Pain From Low Back Pain (LBP) or Osteoarthritis (OA) of the Hip or Knee

IND # 61,345

TXA107563: A randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and tolerability of TREXIMA™ (sumitriptan succinate/naproxen sodium) for a single moderate or severe headache in adults diagnosed with probable migraine without aura (ICHD-II 1.6.1)

A Phase III Clinical Trial to Study the Safety, Tolerability and Immunogenicity of Zoster Vaccine Live (Oka/Merck) in Subjects with a History of Herpes Zoster Protocol V211-014

Amalyn Protocol AFA203: A RANDOMIZED, PARALLEL-GROUP, MULTICENTER STUDY TO EXAMINE THE SAFETY, TOLERABILITY, AND BODY WEIGHT EFFECT OF SUBCUTANEOUS PRAMLINTIDE IN COMBINATION WITH THE ORAL ANTIOBESITY AGENTS SIBUTRAMINE OR PHENTERMINE IN OVERWEIGHT AND OBESE SUBJECTS

SankyoProtocol 866-450: A Prospective, Open Label, Single Arm Study to Evaluate the Safety and Efficacy of an Olmesartan Medoxomil Based Treatment Regimen in Elderly Patients with Hypertension

Sankyo Protocol 866-449: A Prospective, Open Label, Blinded Endpoint Study to Evaluate the Safety and Efficacy of an Olmesartan Medoxomil Based Treatment Regimen in Elderly Patients with Hypertension

Novartis PRSW-GN-301: A Phase III, multi-center, randomized, double-blind, placebo-controlled, parallel group trial of fourteen day treatment with lansoprazole 15 mg once a day in frequent heartburn

Protocol number: CVAH631BUS07

A 10-week multicenter, randomized, double-blind, parallel-group, forced-titration study using 24-hr ABPM to evaluate the efficacy of a Valsartan/hydrochlorothiazide(HCTZ) treatment regimen versus conventional treatment regimen with Amlodipine and hydrochlorothiazide(HCTZ) in patients with Stage 2 hypertension.

Protocol 6115A1-004
A PHASE 3, RANDOMIZED, ACTIVE-CONTROLLED, MODIFIED DOUBLE-BLIND TRIAL EVALUATING THE SAFETY, TOLERABILITY, AND IMMUNOGENICITY OF A 13-VALENT PNEUMOCOCCAL CONJUGATE VACCINE COMPARED TO A 23-VALENT POLYSACCHARIDE VACCINE IN ADULTS 60 TO 64 YEARS OLD WHO ARE NAÏVE TO 23-VALENT POLYSACCHARIDE VACCINE

A Phase III, Multicenter, Randomized, Placebo-Controlled Clinical Trial to the Safety and Efficacy of oral MK-0974 in the Acute Treatment of Migraine With or Without Aura Protocol NO: 016

866-451, Clinical Protocol
"A Double-Blind, Randomized, Placebo-Controlled, Parallel-Group Study to Compare the Safety and Efficacy of an Olmesartan medoxomil Based Treatment Regimen to Placebo in Patients With Stage I and Stage II Hypertension"

V211-015: A Phase III Clinical Trial to Evaluate the Safety and Tolerability of ZOSTAVAX™ in Subjects 50 to 59 Years of Age
PRSW-GN-305. A phase III, multi-center, randomized, double-blind, placebo-controlled, parallel group trial of fourteen day treatment with lansoprazole 15 mg or 30 mg once a day in frequent nighttime heartburn.

Protocol KF5503/23(Grünenthal) R331333-PAI-3011 (J&JPRD): A Randomized Double-Blind, Placebo- and Active-Control, Parallel-arm, Phase III Trial with Controlled Adjustment of Dose to Evaluate the Efficacy and Safety of CG5503 Extended-Release (ER) in Subjects with Moderate to Severe Chronic Low Back Pain IND #61,345

A Multicenter, Double-Blind, Active-Controlled, Parallel Group Study to Examine the Safety, Tolerability and Efficacy of Oral MK-0974 for the Long Term Treatment of Acute Migraine With or Without Aura Protocol 012

Title: Open-Label Study of the Safety and Efficacy of a New Low Dose Oral Contraceptive Containing Norethindrone Acetate and Ethinyl Estradiol - PR-05806

MK-0653 Protocol 112: A Multicenter, Randomized, Double-Blind, Parallel Arm, 12- Week Study to Evaluate the Efficacy and Safety of Ezetimibe 10 mg When Added to Atorvastatin 10 mg Versus Titration to Atorvastatin 20 mg and to 40 mg in Eldery Patients With Hypercholesterolemia at High Risk for CHD

Novartis Pharmaceuticals Trial entitled: A randomized, multicenter, double-blind, double-dummy, parallel-group study of acetaminophen or fluvastatin compared to placebo on the transient Post-Dose Symptoms (PDS) following an i.v. infusion of a single dose of zoledronic acid 5mg, in post-menopausal women with low bone mass Protocol No: CZOL446H US136

Protocol: ATL1251/038/CL "A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study of Renzapride in Women with Constipation-Predominant Irritable Bowel Syndrome (c-IBS)"

NEB-MD-10 A Prospective, Randomized, Open-Label, Parallel Group Study to Compare the Tolerability of Nebivolol to Other Beta Blockers in Patients with Stage I or Stage II Hypertension

Protocol: ATL1251/052/CL "A Phase III, Multicenter, Open Label, Extension Study to Evaluate the Long-term Safety of Renzapride 4 mg Once Daily in Women with Constipation-Predominant Irritable Bowel Syndrome (c-IBS)"

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety and Tolerability of AV965 in Elderly Subjects with Age-Associated Memory Impairment

A phase IIIb, controlled, multicenter study to evaluate antibody persistence at 1, 3, 5 and 10 years following administration of a single dose of Tdap vaccine to healthy subjects, 19 years of age and older in the study 106316 (Tdap 0.3-007).

Protocol KF5503/18 (Grunenthal) R331333-PAI-3010 (J&J PRD): Open-Label Extension, Single-Arm, Flexible-Dosing, Phase III Trial with CG5503 Extended-Release (ER) in Subjects with Moderate to Severe Chronic Pain

A Randomized, Double-Blind, Multiple-Site, Placebo Controlled, Parallel Design, Clinical Study to Evaluate the Bioequivalence of Adapalene Gel 0.1% (Barr Laboratories, Inc.) Compared to Differin® (adapalene 0.1%) Topical Gel (Galderma Laboratories) in Patients with Moderate to Severe Acne Vulgaris

Protocol NAL 20: Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study of the Analgesic Efficacy of Nalbuphine-ER in patients with Chronic Pain Secondary to Osteoarthritis of the Knee / Hip

NB 304: A Multicenter, Randomized, Double Blind, Placebo Controlled Study Comparing the Safety and Efficacy of Multiple Doses of Naltrexone Sustained Release (SR)/Bupropion Sustained Release (SR) and Placebo in Obese Subjects with Type 2 Diabetes Mellitus.

A multi-center, randomized, double-blind, placebo controlled study of the effect of SSR180575 at two doses for 24 weeks treatment on the rate of regeneration of epidermal nerve fibers in patients with mild diabetic eripheral neuropathy

A Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study Comparing Perrigo Israel Pharmaceuticals Ltds’ Metronidazole Topical Gel 1% to METROGEL® (metronidazole gel), 1% and Both Active Treatments to a Vehicle Control in the Treatment of the Inflammatory Lesions of Rosacea.

A Phase 3, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-491 in Subjects with Essential Hypertension.

An 8-Month Phase 3, Open-Label Study With a Blinded Reversal Phase to Evaluate the Safety and Tolerability of TAK-491 in Subjects with Essential Hypertension

An Open Label Study of the Contraceptive Efficacy of an Extended Regimen of Norenthindrone and Ethinyl Estradiol.

A Randomized, Double-blind, 12-Week Study to Evaluate the Efficacy of ThermoProfen™ in the Treatment of Patients with Mild to Moderate Pain Associated with Osteoarthritis of the Knee

Title: The Efficacy and Safety of TDS-943 in the Treatment of Osteoarthritis of the Knee: Pivotal Study I

A Phase 3, Randomized, Active-Controlled, Modified Double-blind Trial to Evaluate the Safety, Tolerability, and Immunogenicity of 13-valent Pneumococcal Conjugate Vaccine When Administered Over 12 Months Either as a 2-dose Regimen or With 23-valent Pneumococcal Polysaccharide Vaccine in Healthy Adults 60 to 64 Years of Age Who Are Naïve to 23vPS

A Phase III Randomized, Double-Blind, Placebo Controlled Multicenter Study to Determine the Safety and Efficacy of VI-0521 in the Treatment of Obesity in Adults with Obesity-Related Co-Morbid Conditions

A Phase III Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Determine the Safety and Efficacy of VI-0521 in the Treatment of Obesity in an Adult Population with BMI ≥ 35

A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-491 in Black Subjects with Essential Hypertension

A Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-491 When Co Administered With Amlodipine 5 mg in Subjects With Essential Hypertension.

“Immunogenicity and Safety of Two Dosages of the Split, Inactivated, Trivalent Influenza Vaccine Administered by Intradermal Route in the Elderly Compared with Standard Fluzone® in Adults and Elderly Subjects”

A Prospective, Open-Label Study to Assess the Efficacy and Safety of an Olmesartan and Amlodipine Based Treatment Regimen in Subjects with Stage 1 and Stage 2 Hypertension

Evaluation of the Immunogenicity, Safety, Reactogenicity, Efficacy, Effectiveness and Lot Consistency of FluBlØk™
Trivalent Recombinant Baculovirus-Expressed Hemagglutinin Influenza Vaccine In Healthy Adults Aged 18 to 49

A 12-WEEK, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, MULTICENTER TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF A FESOTERODINE FLEXIBLE DOSE REGIMEN IN PATIENTS WITH OVERACTIVE BLADDER

A Multicenter, Randomized, Double Blind, Placebo Controlled Study Comparing the Safety and Efficacy of Two Doses of Naltrexone Sustained Release (SR)/Bupropion Sustained Release (SR) and Placebo in Obese Subjects

A multi-center, randomized, double-blind, placebo and active controlled, parallel group, dose range study to evaluate the efficacy and safety of LCZ696 comparatively to valsartan, and to evaluate AHU377 to placebo after 8 week treatment in patients with essential hypertension

A 24-Week, Blinded, Randomized, Placebo-Controlled Dose-Ranging Trial of Nasal PYY3-36 For Weight Loss in Healthy Obese Patients

A Phase IV Clinical Trial to Evaluate the Safety and Tolerability of ZOSTAVAX™ in Subjects ≥ 60 Years of Age

A Multicenter, Randomized, Double-Blind, Parallel Arm, 12- Week Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin Combination Tablet Versus Atorvastatin in Eldery Patients With Hypercholesterolemia at Moderately High Risk and High Risk for Coronary Heart Disease

A Randomized, Double-Blind, Placebo- and Active Comparator Controlled Study to Assess the Efficacy and Tolerability of MK-8141 in hypertensive Patients

DOUBLE BLIND, PLACEBO CONTROLLED PHASE 3 STUDY OF THE EFFICACY OF AN INVESTIGATIONAL VERO CELL-DERIVED INFLUENZA VACCINE (VCIV) TO PREVENT CULTURE CONFIRMED INFLUENZA INFECTION (CCII)

A Phase 3 Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Intramuscular Peramivir in Subjects with Uncomplicated Acute Influenza

A 52-Week, Double-blind, Randomized, Placebo-controlled, Parallel-Group Study to Assess the Safety and Efficacy of Lorcaserin Hydrochloride in Overweight and Obese Patients