NCT00563368

A Study Comparing Multiple Doses of VI-0521 With Placebo and Their Single-agent Constituents for Treatment of Obesity in Adults

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 756 (actual)
• Sponsor: VIVUS LLC · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Obesity

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

Timeline

• Start date: 2007-12-01
• Primary completion: 2008-09-01
• Completion: 2008-09-01
• First posted: 2007-11-26
• Last updated: 2015-03-30
• Results posted: 2012-09-03

Locations

2 sites across 1 country: United States