Trials / Completed
CompletedNCT00745251
A Study of VI-0521 for the Treatment of Obstructive Sleep Apnea / Hypopnea Syndrome in Obese Adults
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of VI-0521 for the Treatment of Obstructive Sleep Apnea / Hypopnea Syndrome in Obese Adults
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 45 (actual)
- Sponsor
- VIVUS LLC · Industry
- Sex
- All
- Age
- 30 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
The primary objectives of this study are to evaluate the safety and efficacy of VI-0521 compared to placebo in the treatment of obese adults with obstructive sleep apnea (OSA) and to assess the relative contributions of weight loss on parameters of OSA in these subjects.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | VI-0521 | 15 mg Phentermine and 92 mg Topiramate |
| DRUG | placebo | placebo |
Timeline
- Start date
- 2008-08-01
- Primary completion
- 2009-09-01
- Completion
- 2009-12-01
- First posted
- 2008-09-03
- Last updated
- 2012-10-05
- Results posted
- 2012-10-05
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00745251. Inclusion in this directory is not an endorsement.