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

September 5, 2012 updated by: VIVUS LLC

A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of VI-0521 for the Treatment of Obstructive Sleep Apnea / Hypopnea Syndrome in Obese Adults

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40217
        • Kentucky Research Group

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Obese adults 30 - 65 years old (inclusive);
  • Women of child-bearing potential must be using adequate contraception;
  • BMI between 30 and 40 kg/m2 (inclusive);
  • Diagnosis of OSA syndrome with Apnea/Hypopnea Index (AHI) of 15 or greater;
  • Unwilling or unable to comply with CPAP treatment;

Exclusion Criteria:

  • Known allergy or hypersensitivity to phentermine or topiramate;
  • Sleep disorder other than OSA syndrome;
  • Women who are pregnant, breast feeding, or intend to become pregnant during the study;
  • Presence of unstable angina or heart failure corresponding to NYHA functional class III or IV;
  • History of myocardial infarction or coronary revascularization within the past year; any history of stroke;
  • Presence of any clinically significant abnormality on electrocardiogram;
  • Use of any prescription CNS stimulants;
  • History of cholecystitis or cholelithiasis unless treated by cholecystectomy;
  • History of glaucoma or any past or present use of medications to treat increased intraocular pressure;
  • Weight gain or loss of greater than 5 kg, use of a very low-calorie diet, or participation in a formal weight loss program (investigational or otherwise) within the past 3 months;
  • Previous bariatric surgery;
  • Shift workers or any subjects with a circadian rhythm disorder;
  • Professional drivers or commercial pilots;
  • History of nephrolithiasis;
  • More than one lifetime episode of major depression;
  • History of bipolar disorder, obsessive compulsive disorder, borderline personality disorder, psychotic depression, schizophrenia, schizoaffective disorder, or any other psychotic disorder; history of any psychiatric hospitalization;
  • History of a seizure disorder; concurrent use of any anticonvulsant drug (other than assigned study drug);

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: placebo
placebo
Experimental: VI-0521
15 mg Phentermine and 92 mg Topiramate
Drug: VI-0521
15 mg Phentermine and 92 mg Topiramate
Other Names:
  • Qnexa
  • PHEN/TPM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Apnea/Hypopnea Index (AHI) Between Baseline and Week 28/Early Term.
Time Frame: between baseline and Week 28
AHI is calculated as the mean number of apnea or hypopnea episodes (each lasting a minimum of 10 second) observed per hour of sleep
between baseline and Week 28

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent Change in Weight From Baseline to Week 28
Time Frame: baseline to week 28
baseline to week 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VIVUS LLC

Investigators

  • Study Director: Charles Bowden, MD, VIVUS LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

September 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

August 31, 2008

First Submitted That Met QC Criteria

August 31, 2008

First Posted (Estimate)

September 3, 2008

Study Record Updates

Last Update Posted (Estimate)

October 5, 2012

Last Update Submitted That Met QC Criteria

September 5, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OB-204

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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