Andrea J. Ramsay, M.D.
Experience:
7/99 - Present
University Clinical Research, Inc.
Investigator
1150 North University Drive
Pembroke Pines, FL 33024
7/99 - Present University Medical Center
Physician/Private Practice
1150 N. University Drive
Pembroke Pines, FL 33024
7/95 – 6/96
Family Medicine and Surgery Clinic
Homestead, Florida
Medical Assistant
Summers of
USMLE Test Coordinator for
1992, 1993, 1995
preparation / review course.
2/92 – 4/93
Knowles Emergency Animal Clinic
Veterinarian Technician
Education:
7/97 – 6/99
University of Miami / Jackson Memorial
Hospital
Residency PGY-2 and PGY-3
Family Medicine
Emphasis in Obstetrics and Women’s Health Issues.
6/96 – 6/97
State University of New York / Buffalo General Hospital / Niagara Falls Memorial
Internship, Family Medicine
Emphasized Balint group training, Intensive Care Unit care, Obstetrics, sigmoidoscopy, and intensive didactic clinical skills training.
8/89 – 6/95
St. George’s University School of Medicine
Doctor of Medicine
First two years of Basic Sciences in Grenada, West
Indies. Worked as teaching assistant for
Neuroanatomy, Anatomy and Histology. Fifth
semester: Clinical Sciences in St. Vincent, West
Indies with rotations at Kingston’s Hospital in
Surgery, Obstetrics, Pediatrics, Medicine and
Physical Diagnoses. Next two years completed in
the United States (New York and New Jersey).
8/85 – 6/89
University of Florida
Bachelor of Science in Microbiology and Minor in
Chemistry. Worked as a Renal Transplant,
Pediatric ICU, and Surgical Technician.
ANDREA J. RAMSAY, MD
CURRICULUM VITAE
PAGE 2
Awards:
9/98
C. Everett Koop Leadership Award
9/97
Glaxo Wellcome Scholar Award
6/95
SAEM Award for Academic Excellence in
Emergency Medicine
8/89
Geoffrey Bourne Academic Scholarship
Organizational Membership:
· Florida Academy of Family Physicians (Ambassador)
· American Medical Association
· American Academy of Family Physicians
· Women Academy of Family Physicians
· Southwest Broward Regional Chamber of Commerce
· National Consortium Physician Resident Organization (Executive Committee)
License:
State of Florida (# ME-0076836)
Certification:
Board certified in Family Medicine (7-9-99)
Certificates:
11/04
Advanced Cardiac Life Support
7/4/03
Basic Life Support
1996
Pediatric Advanced Life Support
1996
Neonatal Advanced Life Support
Languages:
English / Spanish
MINI Experience:
Have been performing the Mini International Neuropsychiatric Interview for over 5 years in both the clinical and research practice at least 960 times a year.
MULTI-CENTER, DOUBLE BLIND, RANDOMIZED, PARALLEL GROUP, 28-WEEK STUDY TO EVALUATE THE EFFICACY AND SAFETY OF *** AND *** CO-ADMINISTRATION VERSUS *** IN PATIENTS WITH HYPERCHOLESTEROLEMIA.
MULTI-CENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP DOSE RESPONSE STUDY TO INVESTIGATE THE EFFICACY, SAFETY AND DOSE RESPONSE RELATIONSHIP OF *** GIVEN ON-DEMAND FOR TWELVE WEEKS IN MEN WITH ERECTILE DYSFUNCTION.
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 *** FOR 8 WEEKS IN SUBJECTS WITH MILD-TO-MODERATE ESSENTIAL HYPERTENSION.
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 *** FOR 8 WEEKS IN SUBJECTS WITH MILD-TO-MODERATE ESSENTIAL HYPERTENSION.
MULTICENTER, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL STUDY COMPARING *** 75 MG AND *** 20 MG FOR POSTPRANDIAL AND NOCTURNAL HEARTBURN.
A PLACEBO-CONTROLLED, DOUBLE-BLIND, RANDOMIZED, PARARLLED STUDY OF THE EFFICACY AND SAFETY OF *** HCI IN THE TREATMENT OF RAPID EJACULATION.
A RANDOMIZED, OPEN-LABEL, COMPARATIVE, MULTI-CENTER TRIAL TO EVALUATE CONTRACEPTIVE EFFICACY, CYCLE-CONTROL, SAFETY AND ACCEPTABILITY OF A *** COC CONTAINING 200 MCG *** AND 20 MCG ***, COMPARED TO A COC CONTAINING 100 MCG *** AND 20MCG ***.
A PHASE III, RANDOMIZED, MULTICENTER CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF COMBINATION ORAL CONTRACEPTIVE REGIMENS UTILIZING *** DURING THE PILL-FREE INTERVAL FOR PREVENTION OF PREGNANCY IN WOMEN.
A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE SAFETY AND EFFICACY OF *** IN THE TREATMENT OF CHRONIC PLAGUE PSORIASIS.
*** VERSES PLACEBO IN THE TREATMENT OF PATIENTS WITH PAINFUL DIABETIC NEUROPATHY.
AN OPEN LABEL, RANDOMIZED STUDY TO EVALUATE THE SAFETY OF 4 MG *** IN SMOKERS WITH CERTAIN UNDERLYING DISEASE RESTRICTION SPECIFIED IN THE LABEL (SMOKING CESSATION).
A RANDOMIZED, DOUBLE BLIND, MULTICENTER, POSITIVE CONTROLLED, PARALLEL-GROUP STUDY TO EVALUATE THE SAFETY AND EFFICACY OF *** AND ***L ADMINISTERED IN COMBINATION COMPARED TO *** ALONE.
HYPERTENSIVE PATIENTS NOT ADEQUATELY CONTROLLED WITH *** ALONE.
STUDY OF THE EFFICACY AD TOLERABILITY OF ONCE DAILY *** AND THREE TIMES DAILY IBUPROFEN vs. PLACEBO IN THE TREATMENT OF SUBJECTS WITH OSTEOARTHRITIS OF THE KNEE.
A RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, FIXED-DOSE, MULTICENTER STUDY OF WEIGHT-REDUCING, EFFECT AND SAFETY OF *** IN OBESE PATIENTS WITH TYPE 2 DIABETES.
A DOUBLE BLIND, RANDOMIZED, ACTIVE AND PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING EVALUATION OF *** IN THE HYPERTENSIVE SUBJECTS.
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP STUDY COMPARING THE EFFICACY OF *** VS. *** IN THE TREATMENT OF MODERATE TO SEVERE HYPERTENSION.
A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ADDITION OF *** TO PATIENTS WITH TYPE 2 DIABETES WITH INADEQUATE GLYCEMIC CONTROL ON COMBINED *** AND *** THERAPY.
A MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP, 6-WEEK STUDY TO EVALUATE THE EFFICACY AND SAFETY OF *** 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.
A PHASE II 12-WEEK RANDOMIZED, DOUBLE-BLIND, FOUR ARM, PLACEBO-CONTROLLED, DOSE RANGING STUDY FOR SAFETY AND EFFICACY OF *** IN TYPE 2 DIABETIC.
SUBJECTS (*** TREATED OR DIET CONTROLLED) AS MEASURED BY GLYCEMIC CONTROL.
A PLACEBO-CONTROLLED, EFFICACY AND SAFETY STUDY OF *** NASAL SPRAY FOR THE TREATMENT OF SEASONAL ALLERGIC RHINITIS.
MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY, PARALLEL-GROUP COMPARISON OF THE REMISSION RATES FOR ONCE DAILY TREATMENT WITH *** 20 MG AND *** 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 *** (40 MG QD) TO *** (30 MG QD) FOR THE HEALING OF EROSIVE ESOPHAGITIS IN PATIENTS WITH MODERATE OR SEVERE EROSIVE ESOPHAGITIS.
A 12-WEEK MULTICENTER, DOUBLE BLIND, RANDOMIZED, PARALLEL-DESIGN STUDY OF 5% *** TOPICAL GEL AND VEHICLE CONTROL IN PATIENTS WITH ACNE VULGARIS.
A PHASE III, RANDOMIZED, MULTICENTER, CLINICAL TRIAL TO EVALUATE THE EFFICACY AND SAFETY OF COMBINATION ORAL CONTRACEPTIVE REGIMENS UTILIZING *** DURING THE PILL-FREE INTERVAL FOR PREVENTION OF PREGNANCY IN WOMEN.
A RANDOMIZED, DOUBLE BLIND COMPARISON OF *** AND *** IN THE TREATMENT OF MILD TO MODERATE HYPERTENSION.
AN OPEN LABEL, RANDOMIZED STUDY TO EVALUATE THE SAFETY OF 4 MG *** LOZENGES IN COMPARISON WITH 4 MG *** GUM IN SMOKERS WITH CERTAIN UNDERLYING DISEASE RESTRICTION SPECIFIED IN THE LABEL (SMOKING CESSATION).
A FOUR-ARM STUDY COMPARING THE ANALGESIC EFFICACY AND SAFETY OF *** HCI ONCE A DAY 100, 200, AND 300 MG VERSUS PLACEBO FOR THE TREATMENT OF PAIN DUE TO OSTEOARTHRITIS OF THE KNEE.
A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ADDITION OF *** TO PATIENTS WITH TYPE 2 DIABETES WITH INADEQUATE GLYCEMIC CONTROL ON COMBINED *** AND *** THERAPY.
A MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, PARALLEL GROUP, 6-WEEK STUDY TO EVALUATE THE EFFICACY AND SAFETY OF *** 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.
A PHASE III, DOUBLE-BLIND, OUTPATIENT, EXTENSION STUDY TO ASSESS THE LONG-TERM SAFETY OF TWO LEVELS OF *** IN ELDERLY PATIENTS WITH PRIMARY INSOMNIA.
A PHASE III, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, OUTPATIENT STUDY TO ASSESS THE EFFICACY AND SAFETY OF TWO DOSE LEVELS OF *** IN ELDERLY PATIENTS WITH PRIMARY INSOMNIA.
A RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL DESIGN, MULTI-SITE STUDY TO EVALUATE THE CLINICAL EQUIVALENCE OF TWO *** 2% SHAMPOOS IN PATIENT WITH TINEA (PITYRIASIS) VERSICOLOR.
EFFICACY OF *** AS AN ADD-ON TO SIMVASTATIN THERAPY.
EFFICACY OF *** AS AN ADD-ON TO ATORVASTATIN THERAPY.
EFFICACY OF *** AS AN ADD-ON TO PRAVASTATIN THERAPY.
A RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP, FIXED-DOSE, MULTICENTER STUDY OF WEIGHT-REDUCING, EFFECT AND SAFETY OF *** IN OBESE PATIENTS WITH TYPE 2 DIABETES.
A PHASE II 12-WEEK RANDOMIZED, DOUBLE-BLIND, FOUR ARM, PLACEBO-CONTROLLED, DOSE RANGING STUDY FOR SAFETY AND EFFICACY OF *** IN TYPE 2 DIABETIC SUBJECTS (*** TREATED or DIET CONTROLLED) AS MEASURED BY GLYCEMIC CONTROL.
DOUBLE BLIND, DOUBLE-DUMMY, RANDOMIZED PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE SAFETY AND EFFICACY *** NASAL SPRAY 0.042% IN ADOLESCENT AND ADULT PATIENTS WITH SEASONAL ALLERGIC RHINITIS.
SAFETY AND EFFICACY OF OLOPATADINE NASAL SPRAY 0.1% VS. *** NASAL SPRAY VEHICLE IN THE PREVENTION OF SYMPTOMS OF SEASONAL ALLERGIC RHINITIS WITH *** HCL NASAL SPRAY 0.1% (*** REGISTERED) AS A REFERENCE STANDARD.
A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, VEHICLE-CONTROLLED, PARALLEL-GROUP STUDY COMPARING *** INC.'S GENERIC *** TOPICAL SUSPENSION, 10% TO *** LOTION, 10% (*** LOTION, 10%) AND BOTH ACTIVE TREATMENTS TO A VEHICLE IN THE TREATMENT OF ACNE VULGARIS.
A 6 week, Randomized, Open Label, Comparative Study to Evaluate the Efficacy and Safety of *** and *** in the Treatment of Hypercholesterolemia in Hispanic Subjects.
A RANDOMIZED, DOUBLE BLIND, PLACEBO CONTROLLED, PARALLEL DESIGN, MULTI-SITE STUDY TO EVALUATE THE CLINICAL EQUIVALENCE OF TWO *** 2% SHAMPOOS IN PATIENT WITH TENEA (PITYRIASIS) VERSICOLOR.
Randomized, Double-Blind, Parallel Group Study to Compare the Safety and Efficacy of *** Gastric Retentive (GR) QD and *** Immediate Release (IR) BID in the Treatment of Uncomplicated Female Urinary Tract Infections.
OPEN-LABEL USE OF *** IN THE TREATMENT OF MILD TO MODERATE HYPERTENSION.
A mulitcenter, Randomized, Double blind, parrallel group, placebo controlled efficacy study comparing 4 weeks of treatment with *** 20 mg qd to placebo qd for the resolution of upper abdominal pain in patients with symptomatic gastroesphageal reflux disease.
A randomized, double bliND, double dummy, parallel group, multi - center study to investigate the time of onset of action of 10mg and 20mg of *** compared to placebo in males with erectile dysfunction.
Prospective, open label non-comparative, multi-center trial to evaluate the efficacy and safety of *** extended release (*** XR) 500 mg once daily for 3 days in the treatment of female patients with acute, uncomplicated, symptomatic, lower urinary tract infections.
A randomized, double-blind, parellel-group, placebo-controlled study evaluating the efficacy, saftey, and reliability,of 10mg *** administered for 12 weeks compared to placebo in subjects with erectile dysfunction and a demonstrated successful first response to 10mg.
A FOUR-ARM STUDY COMPARING THE ANALGESIC EFFICACY AND SAFETY OF *** HCI ONCE A DAY 100, 200, AND 300 mg VERSUS PLACEBO FOR THE TREATMENT OF PAIN DUE TO OSTEOARTHRITIS OF THE KNEE.
A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, STUDY TO EVALUATE THE SAFETY AND EFFICACY OF THE ADDITION OF *** TO PATIENTS WITH TYPE 2 DIABETES WITH INADEQUATE GLYCEMIC CONTROL ON COMBINED *** AND *** THERAPY.
A Randomized, Placebo Controlled, Parallel Group, Double Blind Study to Evaluate the Safety and Efficacy of *** 12.5 mg and *** 200 mg in Patients with Osteoarthritis of the Knee.
A multicenter, double blind, randomized, parallel group, 6-week study to evaluate the efficiacy and safety of ***/*** combination tablets versus *** in patients with hypercholesterolemia.
A 12-week, mulit-center, open-label forced titration study to investigate the efficacy and safety of *** (160mg), *** (320mg) and ***/*** (12.5mg) in the treatment of mild to moderate hypertensive subjects.
A 12-week, double-blinded, placebo-controlled, randomized, multicenter study with follow up evaluating the safety and efficacy of *** (CP 526, 555) in comparison to *** for smoking cessation.
This study will be a multi-center, double-blind, randomized, placebo -controlled, parallel group design to investigate the efficacy, tolerability, and safety of a 60mg dose t.i.d. of *** in an overweight population with a BMI of >25 and <28.
A 12-week randomized, double- blinded, placebo, controlled multicenter study of the Analgesic efficacy of ***, 200 mg QD and 200 mg BID compared to Placebo in Patients with Chronic lower back pain.
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Outpatient, Safety anD Efficacy Study of *** in Elderly Subjects with Chronic Insominia.
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Outpatient, Safety and Efficacy Study of *** in Adults with Chronic Insomnia.
A PHASE II 12-WEEK RANDOMIZED, DOUBLE-BLIND, FOUR ARM, PLACEBO-CONTROLLED, DOSE RANGING STUDY FOR SAFETY AND EFFICACY OF *** IN TYPE 2 DIABETIC SUBJECTS (GLYBURIDE TREATED or DIET CONTROLLED) AS MEASURED BY GLYCEMIC CONTROL.
A Multi-Center , Randonized, Double-Blind, Parallel Group, Placebo-Controlled Study Of Efficacy And Safety Of *** Therapy In Improving Walking 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 *** to patients with type 2 diabetes with inadequate glycemic control on combined *** and *** theraphy.
A RANDOMIZED, DOUBLE-BLIND, MULTICNTER, PLACEBO-CONTROLLED, PARALLEL GROUP STUDY TO EVALUATE THE EFFICACY AND SAFETY OF *** (320 MG) AND ***(12.5 AND 25 MG) COMBINED AND ALONE, *** 160 MG AND *** 160 MG/ *** 12.5 IN HYPERTENSIVE PATIENTS.
A DOULBLE-BLIND, RANDOMIZED, CONTROLLED, PARALLEL-GROUP, MULTICENTER STUDY EVALUATING THE SAFETY AND EFFICACY OF *** CREAM 0.075% AS A TREATMENT IN SUBJECTS WITH OSTEOARTHRITIS OF THE KNEE.
A 6-week open label, randomised, multicenter, phase iiib, parallel group study to compare the efficacy and safety of *** (10mg) with *** (20mg) in subjects with hypercholesterolemia and with a history of coronary disease or clinical evidence of atherosclerosis or a CHD risk quivalent (10 year risk score of >20%)
A randomised, double-blinded, double-dummy, placebo-controlled, forced- titration, comparison of *** HCT verses *** HCT using seated trough cuff blood pressure in patients with stage 1 and stage 2 hypertension.
A randomized, double-blind, parellel-group, placebo-controlled study evaluating the efficacy, saftey, and reliability, of 10mg *** administered for 12 weeks compared to placebo in subjects with erectile dysfunction and a demonstrated successful first response to 10mg.
A Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Study to Evaluate the Safety and Efficacy of *** 12.5 mg and *** 200 mg in Patients with Osteoarthritis of the Knee.
A double blind, randomized, placebo controlled, multicenter study to assess the safety, tolerability and efficacy of *** in obese patients.
A multicenter, double blind, randomized, parallel group, 6-week study to evaluate the efficiacy and safety of ***/*** combination tablets vesus *** in patients with hypercholesterolemia.
A Multicenter, double-blinded, active and placebo-controlled efficacy and safety study of *** HCI and low dose *** HCI in patient with low back pain.
A 12-week, double-blinded, placebo - controlled, randomized, multicenter study with follow up evaluating the safety and efficacy of *** in comparison to *** for smoking cessation.
A double-blinded, placebo-controlled study of the efficacy and tolerablility of once daily *** vs placebo in the treatment of the knee non-responsive to *** and ***.
The Efficacy and safety of *** 150/12.5 MG and *** 300/25 MG In Patients with hypertension uncontrolled on monotherapy.
A phase 3, parallel group, randomized, double blinded, placebo controlled, multicenter trail to investigate the efficacy, tolerability and safety of *** sustained release in subjects with overactive bladder syndrome.
A six-month study, chronic efficacy and safety of *** in adult subjects with primary insomnia: A randomized, double blinded, placebo controlled study.
Sympton Relief suffering from gastoesophagela reflux disease grade A to D according to Los Angeles (LA) classification treated with *** 40 MG QD or *** 40 MG QD.
A randomized, double blinded, multicenter, placebo-controlled, parallel group study to evaluate the efficacy and safety of *** and *** combined and alone, *** 160mg and *** 160 mg/*** 12.5 mg in hypertensive patients.
RANDOMIZED, DOUBLE-BLIND TRIAL OF *** 250-mg TAblets compared to placebo in patients with acute, painful musculoskeletal spasm.
A RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY AND SAFETY OF *** (5 MG AND 20 MG) ADMINISTERED ONCE DAILY TO SUBJECTS WITH MILD-TO-MODERATE HYPERTENSION.
A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED STUDY TO EVALUATE THE EFFECT OF *** 90 mg AND *** 20 mg IN A CONTINUOUS DAILY REGIMEN ON CYCLE-RELATED SYMPTOMS (CRS).
A DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, PARALLEL GROUP STUDY OF THE EFFICACY AND SAFETY OF ORAL DOSES OF 20 MG *** WHEN USED ON DEMAND FOR UP TO 7 EPISODES OVER A PERIOD OF 6 WEEKS FOR THE TREATMENT OF OCCASIONAL EPISODES OF SELF-REPORTED ABDOMINAL PAIN, CRAMPING, AND DISCOMFORT IN AN OTC-LIKE STUDY POPULATION.
DETERMINATION OF THE MINIMAL CLINICALLY IMPORTANT DIFFERENCE OF THE PATIENT-ORIENTATED SELF-ASSESSMENT SCALE REQUEST™ IN PATIENTS SUFFERING FROM ENDOSCOPICALLY CONFIRMED GASTROESOPHAGEAL REFLUX DISEASE (GERD), GRADE A-D ACCORDING TO LOS ANGELES CLASSIFICATION TREATED WITH *** 40MG O.D. OR PLACEBO O.D. OVER ONE WEEK.
A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, FOUR ARM STUDY TO EVALUATE THE CLINICAL EFFICACY AND SAFETY OF *** ER 4MG IN MEN WHO HAVE FREQUENCY AND URGENCY, WITH OR WITHOUT URINARY URGE INCONTINENCE, WITH OR WITHOUT BLADDER OUTLET OBSTRUCTION.
A PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF *** COMPARED TO PLACEBO ON SYMTOM RELIEF IN SUBJECTS WITH SYMPTOMATIC NON-EROSIVE GASTROESOPHAGEAL REFLUX DISEASE (GERD).
A PHASE 3 STUDY TO EVALUATE THE EFFICACY AND SAFETY OF *** (60 MG QD AND 90 MG QD) AND AN ACTIVE COMPARATOR, LANSOPRAZOLE (30 MG QD) ON HEALING OF EROSIVE ESOPHAGITIS.
A PHASE 3 STUDY TO EVALUATE THE SAFETY AND EFFICACY OF *** (60 MG QD AND 90 MG QD) COMPARED TO PLACEBO IN MAINTENANCE OF HEALING OF SUBJECTS WITH HEALED EROSIVE ESOPHAGITIS.
A PHASE 3, OPEN-LABEL STUDY TO ASSESS THE LONG-TERM SAFETY OF *** (60 MG QD AND 90 MG QD).
A TWO-WEEK, DOUBLE-BLIND, PLACEBO-CONTROLLED, RANDOMIZED, PARALLEL GROUP, EFFICACY AND SAFETY, OUT-PATIENT TRIAL WITH *** IN PATIENTS WITH CHRONIC PRIMARY INSOMNIA.
A Six Week Double-Blind, Randomized, Multicenter Comparison Study of the Analgesic Effectiveness of *** 200 mg BID Compared to *** 50 mg QID in Subjects with Chronic Low Back Pain.
A 12-WEEK RANDOMIZED, CONTROLLED, PILOT STUDY TO EVALUATE THE EXPOSURE TO SMOKE CONSTITUENTS OF THE *** CIGARETTE SMOKING SYSTEM (EHCSS-K) IN ADULT SMOKERS.
RANDOMIZED, DOUBLE-BLIND TRIAL OF *** 350 MG AND 250 MG TABLETES COMPARED TO PLACEBO IN PATIENTS WITH ACUTE, PAINFUL MUSCULOSKELETAL SPASM OF THE LOWER BACK.
A RANDOMIZED, DOUBLE-BLIND, MULTICENTER, PLACEBO-CONTROLLED, PARALLEL STUDY EVALUATING THE SAFETY OF *** IN SUBJECTS WITH CONTROLLED ESSENTIAL HYPERTENSTION (STAGE 1 OR 2).
A MULTICENTER, DOUBLE-BLIND, RANDOMIZED, CROSS-OVER, NAPROXEN-CONTRLLED STUDY TO EVALUATE THE EFFECTS OF *** (750 MG, BID) AND *** (500 MG BID) ON ARTERIAL BLOOD PRESSURE AS MEASURED BY AMBULATORY BLOOD PRESSURE MONITORING IN VOLUNTEER SUBJECTS WITH STABLE ESSENTIAL HYPERTENSION.
A PHASE 3 STUDY TO EVALUATE EFFICACY AND SAFETY OF *** (30 MG QD AND 60 MG QD) COMPARED TO PLACEBO ON SYMPTOM RELIEF IN SUBJECTS WITH SYMPTOMATIC NON-EROSIVE GASTROESOPHAGEAL REFLUX DISEASE (GERD).
A LONG-TERM SAFETY AND EFFICACY STUDY OF *** IN ELDERLY SUBJECTS WITH PRIMARY CHRONIC INSOMNIA.
A PHASE II, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PROOF OF CONCEPT, EFFICACY AND SAFETY STUDY OF *** AND *** IN TREATING THE SIGNS AND SYMTOMS OF OSTEOARTHRITIS OF THE KNEE.
A 12-WEEK, RANDOMIZED, RANDOMIZED, DOUBLE-BLIND, MULTI-CENTER, VEHICLE-CONTROLLED, PARALLEL GROUP STUDY TO ASSESS THE EFFICACY AND SAFETY OF *** GEL 1% FOR THE RELIEF OF SIGNS AND SYMPTOMS IN PATIENTS WITH OSTEOARTHRITIS OF THE KNEE.
A MULTI-CENTER, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTIPLE DOSE, PARALLEL DESIGN, DOSE-RANGING STUDY OF THE SAFETY AND EFFICACY OF *** IN PATIENTS WITH PAINFUL DIABETIC PERIPHERAL NEUROPATHY.
A RANDOMIZED, DOUBLE-BLIND, PHASE 3 STUDY OF THE EFFICACY AND SAFETY OF *** IN SUBJECTS REQUIRING NSAID TREATMENT.
RANDOMIZED, DOUBLE-BLIND TRIAL OF THE COMBINATION OF *** 250-MG TABLETS AND *** 50-MG TABLETS COMPARED TO PLACEBO AND EITHER PRODUCT ALONE IN PATIENTS WITH ACUTE, PAINFUL MUSCULOSKELETAL SPASM OF THE LOWER BACK.
FIFTY-TWO WEEKS, OPEN-LABEL EXTENSION TRIAL TO EVALUATION SAFETY AND EFFICACY OF *** IN OUTPATIENTS WITH CHRONIC PRIMARY INSOMNIA WHO COMPLETED ORIGINAL CLINICAL TRIAL.
A DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTICENTER STUDY TO ASSESS THE SAFETY, TOLERANCE, AND EFFICACY OF A SINGLE SUBCUTANEOUS DOSE OF *** IN PATIENTS WITH ACUTE MIGRAINE.
A MULTICENTER, OPEN-LABEL, SINGLE-ARM STUDY TO ASSESS THE EFFICACY AND SAFETY OF THE ORAL CONTRACEPTIVE *** IN A FLEXIBLE EXTENDED REGIMEN IN 1356 HEALTHY FEMALES FOR 1 YEAR.
TOLERABILITY OF *** COMPARED WITH *** ER IN PATIENTS WITH MILD TO MODERATE HYPERTENSION.
A RANDOMIZED, MULTICENTER, DOUBLE-BLIND, PLACEBO-CONTROLLED, FOUR-WEEK STUDY TO ASSESS THE EFFICACY AND SAFETY OF *** IN SUBJECTS WITH PAIN CAUSED BY MILD TO MODERATE OSTEOARTHRITIS OF THE KNEE.
A RANDOMIZED-WITHDRAWAL PHASE III STUDY EVALUATING THE SAFETY AND EFFICACY OF *** EXTENDED-RELEASE (ER) IN SUBJECTS WITH PAINFUL DIABETIC PERIPHERAL NEUROPATHY (DPN).
A PHASE III, RANDOMIZED, OBSERVER-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS CLINICAL EFFICACY OF A CELL-DERIVED SUBUNIT INFLUENZA VACCINE AND AN EGG-DERIVED SUBUNIT INFLUENZA VACCINE IN THE 2007-2008 INFLUENZA SEASON IN HEALTHY ADULT SUBJECTS.
A 12-MONTH, PHASE 3, OPEN-LABEL, MULTI-CENTER STUDY TO EVALUATE THE LONG-TERM SAFETY OF *** IN SUBJECTS WHO ARE AT RISK FOR DEVELOPING NSAID-ASSOCIATED ULCERS.
A 6-MONTH, PHASE 3, RANDOMIZED, DOUBLE-BLIND, PARALLEL-GROUP, CONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE INCIDENCE OF GASTRIC ULCERS FOLLOWING ADMINISTRATION OF EITHER *** OR *** IN SUBJECTS WHO ARE AT RISK FOR DEVELOPING NSAID-ASSOCIATED ULCERS.
A MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PROSPECTIVE STUDY COMPARING THE SAFETY AND EFFICACY *** IN COMBINATION WITH *** AND *** TO *** IN COMBINATION WITH *** IN SUBJECTS WITH COMBINED (ATHEROGENIC) DYSLIPIDEMIA.
A RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, ACTIVE-CONTROLLED, MULTI-CENTER, LONG-TERM STUDY TO ASSESS THE SAFETY AND EFFICACY OF THE *** (50 MG QD AND 100 MG QD) IN SUBJECTS WITH SYMPTOMS OF OVERACTIVE BLADDER.
A DOUBLE-BLIND, RANDOMIZED, MULTI-CENTER STUDY TO INVESTIGATE THE ENDOMETRIAL SAFETY OF CONTINUOUS, COMBINED, ORAL ESTROGEN/PROGESTIN PREPARATION (0.5 MG *** / 0.25 MG ***) TO COMPARE THE BLEEDING PATTERN OF SUBJECTS TREATED WITH 0.5 MG *** / 0.25 MG *** WITH THE BLEEDING OF SUBJECTS TREATED WITH 1.0 MG *** / 0.5 MG *** WHEN USED FOR HORMONE THERAPY (HT) FOR 1 YEAR IN POST-MENOPAUSAL WOMEN.
A PHASE III, RANDOMIZED, DOUBLE-BLIND, PARALLEL GROUP, PLACEBO-CONTROLLED, MULTICENTER STUDY TO ASSESS THE EFFICACY AND SAFETY OF THE BETA AGONIST *** IN SUBJECTS WITH SYMPTOMS OF OVERACTIVE BLADDER.
RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY TRIAL OF TWO SUSTAINED RELEASE FORMULATIONS OF *** COMPARED TO PLACEBO IN PATIENTS WITH ACUTE, PAINFUL MUSCULOSKELETAL SPASM OF THE LOWER BACK.