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

Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00745251
• Other study ID #: OB-204
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: August 31, 2008
• Last updated: September 5, 2012
• Start date: August 2008
• Est. completion date: December 2009

Study information

• Verified date: September 2012
• Source: VIVUS, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: December 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Apnea
• Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Drug:
• VI-0521
15 mg Phentermine and 92 mg Topiramate
• placebo
placebo

Locations

Country	Name	City	State
United States	Kentucky Research Group	Louisville	Kentucky

Sponsors (1)

Lead Sponsor	Collaborator
VIVUS, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in the Apnea/Hypopnea Index (AHI) Between Baseline and Week 28/Early Term.	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	No
Secondary	Percent Change in Weight From Baseline to Week 28		baseline to week 28	No