drugset / Trial / NCT00563368

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

NCT00563368

Phase 3 Completed 756 enrolled VIVUS LLC Medpace, Inc. · collab
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2007-12
Primary completion
2008-09
Completion
2008-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Phentermine Small molecule 7.5 mg Oral
Comparator Phentermine Small molecule 15 mg Oral
Comparator Topiramate Small molecule 46 mg Oral
Comparator Topiramate Small molecule 92 mg Oral

Indications