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

NCT00563368 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 756

Last updated 2015-03-30

Study results available
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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

Interventions

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

Sponsors & Collaborators

  • Medpace, Inc.

    collaborator INDUSTRY

  • VIVUS LLC

    lead INDUSTRY

Principal Investigators

  • Craig Peterson · VIVUS LLC

  • Kishore Gadde, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-12-31
Primary Completion
2008-09-30
Completion
2008-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00563368 on ClinicalTrials.gov