NCT00745251已完成1 期
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of VI-0521 for the Treatment of Obstructive Sleep Apnea / Hypopnea Syndrome in Obese Adults
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- VIVUS LLC
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Change in the Apnea/Hypopnea Index (AHI) Between Baseline and Week 28/Early Term.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
排除标准
- •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);
研究组 & 干预措施
VI-0521
Experimental
15 mg Phentermine and 92 mg Topiramate
干预措施: VI-0521 (Drug)
Placebo
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Change in the Apnea/Hypopnea Index (AHI) Between Baseline and Week 28/Early Term.
时间窗: 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
次要结局
- Percent Change in Weight From Baseline to Week 28(baseline to week 28)
研究者
研究点 (1)
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