NCT00554216

Study of VI-0521 Compared to Placebo in Treatment of Obesity in Adults

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,267 (actual)
• Sponsor: VIVUS LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity

Interventions

Type	Name	Description
DRUG	VI-0521	3.75 mg phentermine/23 mg topiramate
DRUG	VI-0521	15 mg phentermine/92 mg topiramate
DRUG	Placebo matched phentermine/topiramate	Placebo matched phentermine/topiramate

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-05-01
• Completion: 2009-05-01
• First posted: 2007-11-06
• Last updated: 2012-09-10
• Results posted: 2012-09-06

Locations

5 sites across 1 country: United States