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

Study Overview
=================
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.

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

Conditions
-----------------
Sleep Apnea

Intervention / Treatment
-----------------
* Drug: VI-0521
* Drug: placebo


Participation Criteria
=================
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);

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VI-0521<br>15 mg Phentermine and 92 mg Topiramate | Drug: VI-0521<br>* 15 mg Phentermine and 92 mg Topiramate<br>* Other names: PHEN/TPM;|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* placebo<br>|

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. | 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 | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Weight From Baseline to Week 28 |  | baseline to week 28 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep apnea; obesity