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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
VIVUS, Inc.
ClinicalTrials.gov Identifier:
NCT00745251
First received: August 31, 2008
Last updated: September 5, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Sleep Apnea
Drug: VI-0521
Drug: placebo
Phase 1
Phase 2

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

Resource links provided by NLM:


Further study details as provided by VIVUS, Inc.:

Primary Outcome Measures:
  • Change in the Apnea/Hypopnea Index (AHI) Between Baseline and Week 28/Early Term. [ Time Frame: between baseline and Week 28 ] [ Designated as safety issue: No ]
    AHI is calculated as the mean number of apnea or hypopnea episodes (each lasting a minimum of 10 second) observed per hour of sleep


Secondary Outcome Measures:
  • Percent Change in Weight From Baseline to Week 28 [ Time Frame: baseline to week 28 ] [ Designated as safety issue: No ]

Enrollment: 45
Study Start Date: August 2008
Study Completion Date: December 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Placebo Comparator: Placebo Drug: placebo
placebo

  Eligibility

Ages Eligible for Study:   30 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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);
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00745251

Locations
United States, Kentucky
Kentucky Research Group
Louisville, Kentucky, United States, 40217
Sponsors and Collaborators
VIVUS, Inc.
Investigators
Study Director: Charles Bowden, MD VIVUS, Inc.
  More Information

No publications provided

Responsible Party: VIVUS, Inc.
ClinicalTrials.gov Identifier: NCT00745251     History of Changes
Other Study ID Numbers: OB-204
Study First Received: August 31, 2008
Results First Received: July 31, 2012
Last Updated: September 5, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by VIVUS, Inc.:
Sleep apnea; obesity

Additional relevant MeSH terms:
Apnea
Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on September 11, 2014