NCT00553787

Study of VI-0521 Compared to Placebo in Treatment of Diabetes and Obesity in Adults With Obesity-Related Co-Morbid Conditions

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 2,487 (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 VI0521 compared to placebo in treatment of obesity in an adult population with obesity related co-morbid conditions.

Conditions

• Obesity
• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	VI-0521	phentermine 15 mg and topiramate 92 mg, po once daily
DRUG	VI-0521	phentermine 7.5 mg and topiramate 46 mg, po once daily
DRUG	VI-0521	placebo

Timeline

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

Locations

6 sites across 1 country: United States