Phase 2 Randomized Double-Blind Placebo-Controlled 4-Period Single-Dose Crossover Factorial Study to Evaluate the Contribution of the Individual Drug Components to the Efficacy of AD109 in Obstructive Sleep Apnea
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 7
- 主要终点
- Change in Hypoxic Burden (HB) Log10HB[(%*Min)/Hour]
研究概览
简要总结
This is a randomized, 4-period, placebo-controlled, crossover, phase 2 clinical study to examine the efficacy and safety of AD109 versus its individual components or placebo in patients with obstructive sleep apnea.
详细描述
The study is designed to examine the efficacy and safety of AD109 to treat obstructive sleep apnea. The study is a four-period single-dose randomized crossover design in which patients will undergo overnight polysomnographic (PSG) testing with dosing of one of the following 4 treatments: AD109, atomoxetine, R-oxybutynin or placebo. Participants will return 2 weeks after their final crossover PSG for an end of study (EOS) visit.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female, between 25 to 65 years of age, inclusive, at the Screening Visit.
- •AHI 10 to <20, or AHI ≥20 if meets other PSG criteria
排除标准
- •History of narcolepsy.
- •Clinically significant craniofacial malformation.
- •Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or hypertension requiring more than 2 medications for control. A medication for these purposes is defined by dosage form, such that a combination antihypertensive medication is considered 1 medication
- •CPAP should not be used for at least 2 weeks prior to first study PSG
- •History of using oral or nasal devices for the treatment of OSA may enroll as long as the devices are not used during participation in the study.
研究组 & 干预措施
AD109
Oral capsule administered before sleep
干预措施: AD109 (Drug)
AD109
Oral capsule administered before sleep
干预措施: Digit System Substitution Test (Diagnostic Test)
Atomoxetine
Oral capsule administered before sleep
干预措施: Atomoxetine (Drug)
Atomoxetine
Oral capsule administered before sleep
干预措施: Digit System Substitution Test (Diagnostic Test)
R-oxybutynin
Oral capsule administered before sleep
干预措施: R-oxybutynin (Drug)
R-oxybutynin
Oral capsule administered before sleep
干预措施: Digit System Substitution Test (Diagnostic Test)
Placebo
Oral capsule administered before sleep
干预措施: Placebo (Drug)
Placebo
Oral capsule administered before sleep
干预措施: Digit System Substitution Test (Diagnostic Test)
结局指标
主要结局
Change in Hypoxic Burden (HB) Log10HB[(%*Min)/Hour]
时间窗: 1 night (treatment duration) (0-8 hours collected continuously)
Change in Hypoxic Burden (HB) is calculated as the oxygen desaturation 'area under the curve' in association with individual apneas and hypopneas. Due to the known logarithmic distribution of HB, data are primarily expressed and analyzed as Log10HB 4%\[% min/hour\]. Events with 4% or greater desaturations were included in the calculation of HB.
次要结局
未报告次要终点