CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 2,487 enrolled
Drug / intervention
VI-0521 +2 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.

Search/NCT00553787
NCT00553787Phase 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 Adults With Obesity-Related Co-Morbid Conditions

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

In Brief

A Phase 3 clinical trial evaluating VI-0521 for Obesity and Type 2 Diabetes. Completed, enrolled 2,487 participants across 6 sites.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of VI0521 compared to placebo in treatment of obesity in an adult population with obesity related co-morbid conditions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity, Type 2 Diabetes
CountriesUnited States
CollaboratorsMedpace, Inc.

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 6, 2007
Enrollment StartNov 1, 2007
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 18.7 years ago

Interventions

VI-0521drug

phentermine 15 mg and topiramate 92 mg, po once daily

VI-0521drug

phentermine 7.5 mg and topiramate 46 mg, po once daily

VI-0521drug

placebo