Expired Study
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Louisville, Kentucky 40217


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 OSA and to assess the relative contributions of weight loss on parameters of OSA in these subjects.


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);


NCT ID:

NCT00745251


Primary Contact:

Study Director
Charles Bowden, MD
VIVUS, Inc.


Backup Contact:

N/A


Location Contact:

Louisville, Kentucky 40217
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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