NCT00614250已完成2 期
A Double-blind, Randomized, Placebo-controlled, Study of the Safety and Activity of Four Escalating Single Doses of AVE0657 in Patients Suffering From Obstructive Sleep Apnea Hypopnea Syndrome
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Change in Apnea Hypopnea Index (AHI)
研究概览
简要总结
The primary objective of this study is to assess the activity of 4 escalating doses of AVE0657 in comparison to placebo in patients with Obstructive Sleep Apnea Hypopnea Syndrome.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects diagnosed with Obstructive Sleep Apnea Hypopnea Syndrome based on International Classification of Sleep Disorders
排除标准
- •Subjects having been treated by Continuous Positive Airway Pressure, oral appliance during 4-weeks prior to randomization
- •Chronic respiratory disease or inadequate respiratory parameters
- •Body Mass Index (BMI) of ≤20 kg/m² or ≥35 kg/m²
- •Surgical procedure to correct apnea within the last three months.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Dose Level 1
Experimental
干预措施: AVE0657 (Drug)
Dose Level 2
Experimental
干预措施: AVE0657 (Drug)
Dose Level 3
Experimental
干预措施: AVE0657 (Drug)
Dose Level 4
Experimental
干预措施: AVE0657 (Drug)
Placebo
Placebo Comparator
12 subjects: 3 subjects per dose level
干预措施: placebo (Drug)
结局指标
主要结局
Change in Apnea Hypopnea Index (AHI)
时间窗: 2 days
次要结局
- Safety and tolerability(5 days)
研究者
研究点 (2)
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