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Study of VI-0521 Compared to Placebo in the Glycemic Management of Obese Diabetics

NCT00486291 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 210

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 VI-0521 compared to placebo in the glycemic management of obese diabetic adults.

Conditions

Interventions

DRUG

VI-0521

phentermine 15mg/topiramate 100mg

DRUG

Placebo

matched placebo

Sponsors & Collaborators

  • Synteract, Inc.

    collaborator INDUSTRY

  • VIVUS LLC

    lead INDUSTRY

Principal Investigators

  • Barbara Troupin, MD, MBA · VIVUS LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2007-06-30
Primary Completion
2008-04-30
Completion
2008-04-30

Countries

  • United States

Study Locations

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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 NCT00486291 on ClinicalTrials.gov