NCT04746105已完成1 期
A Study to Evaluate the Respiratory Safety of TS-142 in Patients with Obstructive Sleep Apnea Hypopnea.
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Least square mean difference of Apnea hypopnea index (AHI) from placebo
研究概览
简要总结
A study to evaluate the respiratory safety of TS-142 in patients with mild obstructive sleep apnea hypopnea.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese male and female, age 20 years or older at the time of informed consent
- •Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria for obstructive sleep apnea hypopnea
- •Other protocol defined inclusion criteria could apply
排除标准
- •Subjects who meet any of the following criteria will be excluded from this study:
- •Patients who meet the Diagnostic and Statistical Manual of Mental Disorders, fifth edition (DSM-5) criteria excepting obstructive sleep apnea hypopnea and insomnia disorder
- •Patients who have clinically significant respiratory dysfunction (bronchiectasis, emphysema, asthma, etc.) other than obstructive sleep apnea hypopnea
- •Patients with percutaneous arterial oxygen saturation (SpO2) <94% by pulse oximetry at visit 1
- •Other protocol defined exclusion criteria could apply
研究组 & 干预措施
TS-142
Experimental
Period in which subjects received TS-142 10 mg or The night when subjects received TS-142
干预措施: TS-142 (Drug)
Placebo
Experimental
Period in which subjects received placebo or The night when subjects received matched placebo
干预措施: Dose-matched Placebo to TS-142 (Drug)
结局指标
主要结局
Least square mean difference of Apnea hypopnea index (AHI) from placebo
时间窗: Day 1
AHI is a number of apnea and hypopnea events per hour during sleep determined by polyso㎜ography (PSG).
次要结局
- Least square mean difference of the mean SpO2 in total sleep time from placebo(Day 1)
研究者
研究点 (1)
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