At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 676 enrolled
Drug / intervention
VI-0521 +2 moredrug
Likely dose
VI-0521 7.5 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 3 clinical trial evaluating VI-0521 and Placebo for Obesity. Completed, enrolled 676 participants.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
Countries--
CollaboratorsMedpace, Inc.
Timeline
Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 2008
Enrollment StartDec 2008
Primary CompletionJun 2010
Study CompletionJul 2010
TodayJul 2026
First PostedNov 24, 2008
Enrollment StartDec 1, 2008
Primary CompletionJun 1, 2010
Study CompletionJul 1, 2010
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 17.6 years ago
Interventions
VI-0521drug
7.5 mg phentermine and 46 mg topiramate
Placebodrug
placebo
VI-0521drug
15 mg phentermine and 92 mg topiramate