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A Study of VI-0521 for the Treatment of Obstructive Sleep Apnea / Hypopnea Syndrome in Obese Adults

NCT00745251 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2012-10-05

Study results available
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Summary

The primary objectives of this study are to evaluate the safety and efficacy of VI-0521 compared to placebo in the treatment of obese adults with obstructive sleep apnea (OSA) and to assess the relative contributions of weight loss on parameters of OSA in these subjects.

Conditions

Interventions

DRUG

VI-0521

15 mg Phentermine and 92 mg Topiramate

DRUG

placebo

placebo

Sponsors & Collaborators

  • VIVUS LLC

    lead INDUSTRY

Principal Investigators

  • Charles Bowden, MD · VIVUS LLC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2008-08-31
Primary Completion
2009-09-30
Completion
2009-12-31

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 NCT00745251 on ClinicalTrials.gov