CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 756 enrolled
Drug / intervention
VI-0521 +6 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/NCT00563368
NCT00563368Phase 3Completed
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A Phase III, Randomized, Double-Blind, Parallel-Design Study Comparing Multiple Doses of VI-0521 to Placebo and Their Single-Agent Phentermine and Topiramate Constituents for the Treatment of Obesity in Adults

VIVUS LLC·interventional·Posted Nov 26, 2007·Updated Mar 30, 2015

In Brief

A Phase 3 clinical trial evaluating VI-0521, topiramate, and 1 other intervention for Obesity. Completed, enrolled 756 participants across 2 sites.

Detailed Summary

The objective of this study is to evaluate the safety and efficacy of various doses of VI-0521 compared to both placebo, and the single-agent components that comprise each combination dose. This study will provide confirmatory data to demonstrate that doses of VI-0521 have efficacy that is greater than placebo and each of the single-agent components that comprise the combination dose.

Study Details

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

Timeline

Phase 3CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 26, 2007
Enrollment StartDec 1, 2007
Primary CompletionSep 1, 2008
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 18.6 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

topiramatedrug

topiramate 46 mg, po once daily

topiramatedrug

topiramate 92 mg, po once daily

phenterminedrug

phentermine 7.5 mg, po once daily

phenterminedrug

phentermine 15 mg, po once daily

VI-0521drug

placebo, po once daily