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Study of VI-0521 Compared to Placebo in Treatment of Obesity in Adults

NCT00554216 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1267

Last updated 2012-09-10

Study results available
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Summary

The purpose of this study is to evaluate the efficacy and safety of two doses of VI-0521 compared to placebo in treatment of obesity in an adult population with BMI ≥ 35.

Conditions

Interventions

DRUG

VI-0521

3.75 mg phentermine/23 mg topiramate

DRUG

VI-0521

15 mg phentermine/92 mg topiramate

DRUG

Placebo matched phentermine/topiramate

Placebo matched phentermine/topiramate

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
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-11-30
Primary Completion
2009-05-31
Completion
2009-05-31

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 NCT00554216 on ClinicalTrials.gov