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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00745251
First Posted: September 3, 2008
Last Update Posted: October 5, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
VIVUS, Inc.
August 31, 2008
September 3, 2008
July 31, 2012
October 5, 2012
October 5, 2012
August 2008
September 2009   (Final data collection date for primary outcome measure)
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
The primary endpoint is the change in the apnea/hypopnea index (AHI). [ Time Frame: between baseline and Week 28 ]
Complete list of historical versions of study NCT00745251 on ClinicalTrials.gov Archive Site
Percent Change in Weight From Baseline to Week 28 [ Time Frame: baseline to week 28 ]
- Change in the respiratory disturbance index (RDI) - Change in apnea index - Change in the Pittsburgh Sleep Quality Index (PSQI), Epworth Daytime Sleepiness Scale (ESS), and SF-36 scores [ Time Frame: baseline to week 28 ]
Not Provided
Not Provided
 
A Study of VI-0521 for the Treatment of Obstructive Sleep Apnea / Hypopnea Syndrome in Obese Adults
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.
Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Sleep Apnea
  • Drug: VI-0521
    15 mg Phentermine and 92 mg Topiramate
    Other Names:
    • Qnexa
    • PHEN/TPM
  • Drug: placebo
    placebo
  • Experimental: VI-0521
    15 mg Phentermine and 92 mg Topiramate
    Intervention: Drug: VI-0521
  • Placebo Comparator: Placebo
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
45
December 2009
September 2009   (Final data collection date for primary outcome measure)

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);
Sexes Eligible for Study: All
30 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00745251
OB-204
No
Not Provided
Not Provided
VIVUS, Inc.
VIVUS, Inc.
Not Provided
Study Director: Charles Bowden, MD VIVUS, Inc.
VIVUS, Inc.
September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP