JPRN-jRCT2031220501招募中3 期
Phase 3 Study to Evaluate the Efficacy and Safety of Orally Administered BF2.649 in Japanese Patients with Obstructive Sleep Apnea Syndrome Complaining Excessive Daytime Sleepiness despite Treated by Nasal Continuous Positive Airway Pressure (nCPAP), Consisting of a Double-blind, Randomized, Placebo-controlled, Parallel-group, Multicenter Study (Part 1) and Subsequent Open-label Extension Study (Part 2)
chimura Naohisa0 个研究点目标入组 148 人开始时间: 2022年12月9日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 148
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •Individuals who have been diagnosed with obstructive sleep apnea syndrome
- •- Japanese males or females aged 18 years or older at the time of informed consent
- •- Individuals whose daytime sleepiness have not been improved even after 3 months of nCPAP therapy.
- •- Individuals who can continue to use nCPAP during the study.
- •- In the past 1 month, percentage of days wearing nCPAP is at least 70%, and mean wearing time of days wearing is at least 4 hours/day.
- •- ESS score is at least 12 (mean score of baseline period and Day 0)
排除标准
- •- Individuals who have been confirmed to have a comorbidity/complication other than obstructive sleep apnea syndrome (severe insomnia, narcolepsy, restless legs syndrome, idiopathic hypersomnia, recurrent hypersomnia, periodic limb movement disorder, circadian rhythm sleep disorder, parasomnia, insufficient sleep time, etc.) by previously conducted polysomnography (PSG) test etc.
- •-Individuals who need to engage in irregular shift work or nighttime work.
- •-Individuals with a disease that may affect the evaluation of study, such as severe COPD.
研究者
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