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Sponsors and Collaborators: |
VIVUS, Inc. Medpace, Inc. |
---|---|
Information provided by: | VIVUS, Inc. |
ClinicalTrials.gov Identifier: | NCT00553787 |
The purpose of this study is to evaluate the efficacy and safety of VI0521 compared to placebo in treatment of obesity in an adult population with obesity related co-morbid conditions.
Condition | Intervention | Phase |
---|---|---|
Obesity Type 2 Diabetes |
Drug: VI-0521 |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | 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 |
Estimated Enrollment: | 2500 |
Study Start Date: | November 2007 |
Estimated Study Completion Date: | April 2009 |
Estimated Primary Completion Date: | April 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
high dose experimental treatment
|
Drug: VI-0521
phentermine 15 mg and topiramate 92 mg, po once daily
|
2: Experimental
low dose experimental treatment
|
Drug: VI-0521
phentermine 7.5 mg and topiramate 46 mg, po once daily
|
3: Placebo Comparator
Placebo
|
Drug: VI-0521
placebo
|
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Have 2 or more of the following obesity-related co-morbid conditions:
At lease one of the following metabolic criteria:
Exclusion Criteria:
United States, Alabama | |
Research Site | |
Birmingham, Alabama, United States, 35294 | |
United States, Connecticut | |
Research Site | |
Ridgefield, Connecticut, United States, 06877 | |
United States, New York | |
Research Site | |
New York, New York, United States, 10025 | |
United States, North Carolina | |
Research Site | |
Durham, North Carolina, United States, 27710 | |
United States, Ohio | |
Research Site | |
Toledo, Ohio, United States, 43623 | |
United States, Texas | |
Research Site | |
Austin, Texas, United States, 78731 |
Study Director: | Craig Peterson | VIVUS, Inc. |
Study Chair: | Kishore Gadde, MD | Duke University |
Responsible Party: | VIVUS ( Craig Peterson, Sr. Director Clinical Research ) |
Study ID Numbers: | VIVUS OB-303 |
Study First Received: | November 3, 2007 |
Last Updated: | May 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00553787 |
Health Authority: | United States: Food and Drug Administration |
Obesity, Type 2 diabetes |
Obesity Metabolic Diseases Diabetes Mellitus Endocrine System Diseases Overweight Phentermine Body Weight Signs and Symptoms |
Diabetes Mellitus, Type 2 Topiramate Nutrition Disorders Overnutrition Endocrinopathy Glucose Metabolism Disorders Metabolic disorder |