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Study of VI-0521 Compared to Placebo in Treatment of Diabetes and Obesity in Adults With Obesity-Related Co-Morbid Conditions

NCT00553787 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 2487

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 VI0521 compared to placebo in treatment of obesity in an adult population with obesity related co-morbid conditions.

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

VI-0521

placebo

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
2007-11-30
Primary Completion
2009-06-30
Completion
2009-06-30

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 NCT00553787 on ClinicalTrials.gov