Clinical trial NCT00745251: A Study of VI-0521 for the Treatment of Obstructive Sleep Apnea / Hypopnea Syndrome in Obese Adults
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Sleep Apnea
Keywords: Sleep apnea; obesity
Lead sponsor: VIVUS LLC
Sponsor class: INDUSTRY
First posted: 2008-09-03
Enrollment: 45
Sex: ALL
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility 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);

Primary outcomes:
measure: Change in the Apnea/Hypopnea Index (AHI) Between Baseline and Week 28/Early Term.
timeFrame: between baseline and Week 28
Secondary outcomes:
measure: Percent Change in Weight From Baseline to Week 28
timeFrame: baseline to week 28
Other outcomes:
Locations:
city: Louisville
country: United States
facility: Kentucky Research Group
state: Kentucky
Study officials:
affiliation: VIVUS LLC
name: Charles Bowden, MD
role: STUDY_DIRECTOR
References: