Trials / Completed
CompletedNCT00796367
A Safety and Efficacy Study of VI-0521 to Evaluate the Long Term Treatment of Obesity in Adults With Obesity-Related Co-Morbid Conditions. An Extension Study of Protocol OB-303 (NCT00553787)
A Phase 3, Double-Blind, Placebo-Controlled, Multicenter Extension Study (From Study OB-303 [NCT00553787]) to Determine the Safety and Efficacy Of VI-0521 for the Long-Term Treatment Of Obesity in Adults With Obesity-Related Co-Morbid Conditions.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 676 (actual)
- Sponsor
- VIVUS LLC · Industry
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the long-term safety and efficacy of VI-0521 compared to placebo for the treatment of overweight and obesity in adults who have completed study OB-303 (NCT00553787) at selected study sites. This is an extension study of protocol OB-303 (NCT00553787).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | VI-0521 | 7.5 mg phentermine and 46 mg topiramate |
| DRUG | Placebo | placebo |
| DRUG | VI-0521 | 15 mg phentermine and 92 mg topiramate |
Timeline
- Start date
- 2008-12-01
- Primary completion
- 2010-06-01
- Completion
- 2010-07-01
- First posted
- 2008-11-24
- Last updated
- 2012-09-10
- Results posted
- 2012-08-31
Source: ClinicalTrials.gov record NCT00796367. Inclusion in this directory is not an endorsement.