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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
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.
Age
18 - 70 years
Sex
ALL
Healthy Volunteers
No
Research Site
Durham, North Carolina, United States
Research Site
Philadelphia, Pennsylvania, United States
Start Date
December 1, 2007
Primary Completion Date
September 1, 2008
Completion Date
September 1, 2008
Last Updated
March 30, 2015
756
ACTUAL participants
VI-0521
DRUG
VI-0521
DRUG
topiramate
DRUG
topiramate
DRUG
phentermine
DRUG
phentermine
DRUG
VI-0521
DRUG
Lead Sponsor
VIVUS LLC
Collaborators
NCT07472881
NCT01143454
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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