Status:
COMPLETED
A Study of VI-0521 for the Treatment of Obstructive Sleep Apnea / Hypopnea Syndrome in Obese Adults
Lead Sponsor:
VIVUS LLC
Conditions:
Sleep Apnea
Eligibility:
All Genders
30-65 years
Phase:
PHASE1
PHASE2
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 relati...
Eligibility Criteria
Inclusion
- 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
- 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);
Key Trial Info
Start Date :
August 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2009
Estimated Enrollment :
45 Patients enrolled
Trial Details
Trial ID
NCT00745251
Start Date
August 1 2008
End Date
December 1 2009
Last Update
October 5 2012
Active Locations (1)
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1
Kentucky Research Group
Louisville, Kentucky, United States, 40217