CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 1,267 enrolled
Drug / intervention
VI-0521 +2 moredrug
Likely dose
VI-0521 3.75 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.

Search/NCT00554216
NCT00554216Phase 3Completed
CompareCT.gov

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 an Adult Population With BMI ≥ 35

VIVUS LLC·interventional·Posted Nov 6, 2007·Updated Sep 10, 2012

In Brief

A Phase 3 clinical trial evaluating VI-0521 and Placebo matched phentermine/topiramate for Obesity. Completed, enrolled 1,267 participants across 5 sites.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of two doses of VI-0521 compared to placebo in treatment of obesity in an adult population with BMI ≥ 35.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity
CountriesUnited States
CollaboratorsMedpace, Inc.

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 6, 2007
Enrollment StartNov 1, 2007
Primary CompletionMay 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 18.7 years ago

Interventions

VI-0521drug

3.75 mg phentermine/23 mg topiramate

VI-0521drug

15 mg phentermine/92 mg topiramate

Placebo matched phentermine/topiramatedrug

Placebo matched phentermine/topiramate