MedTrace Logo

A Safety and Efficacy Study of VI-0521 to Evaluate the Long Term Treatment of Obesity in Adults With Obesity-Related Co-Morbid Conditions. An Extension Study of Protocol OB-303 (NCT00553787)

NCT00796367 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 676

Last updated 2012-09-10

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to evaluate the long-term safety and efficacy of VI-0521 compared to placebo for the treatment of overweight and obesity in adults who have completed study OB-303 (NCT00553787) at selected study sites. This is an extension study of protocol OB-303 (NCT00553787).

Conditions

Interventions

DRUG

VI-0521

7.5 mg phentermine and 46 mg topiramate

DRUG

Placebo

placebo

DRUG

VI-0521

15 mg phentermine and 92 mg topiramate

Sponsors & Collaborators

  • Medpace, Inc.

    collaborator INDUSTRY

  • VIVUS LLC

    lead INDUSTRY

Principal Investigators

  • Craig Peterson · VIVUS LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-12-31
Primary Completion
2010-06-30
Completion
2010-07-31

More Related Trials

Entities

Drugs
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 NCT00796367 on ClinicalTrials.gov