At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 45 enrolled
Drug / intervention
VI-0521 +1 moredrug
Likely dose
VI-0521 15 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 Randomized, Double-blind, Placebo-controlled, Parallel-group Study of VI-0521 for the Treatment of Obstructive Sleep Apnea / Hypopnea Syndrome in Obese Adults
In Brief
A Phase 2 clinical trial evaluating VI-0521 and placebo for Sleep Apnea. Completed, enrolled 45 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSleep Apnea
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartAug 2008
First PostedSep 2008
Primary CompletionSep 2009
Study CompletionDec 2009
TodayJul 2026
First PostedSep 3, 2008
Enrollment StartAug 1, 2008
Primary CompletionSep 1, 2009
Study CompletionDec 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 17.8 years ago
Interventions
VI-0521drug
15 mg Phentermine and 92 mg Topiramate
placebodrug
placebo