Randomized Double-Blind 2-Period Multiple Dose Crossover Study to Evaluate the Efficacy and Safety of AD113 vs Atomoxetine in OSA Patients With Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 21
- 试验地点
- 3
- 主要终点
- Change in hypoxic burden (HB, total area under the respiratory event-related desaturation curve)
研究概览
简要总结
This is a randomized, double blind, 2-period, non placebo-controlled crossover study in patients with moderate to severe OSA and controlled hypertension, comparing atomoxetine with AD113
详细描述
The study is designed to examine the efficacy and safety of AD113 to treat obstructive sleep apnea with hypertension. The study is a two-period multi-dose randomized crossover design in which patients will undergo overnight polysomnographic (PSG) testing with dosing of one of the following 2 treatments: AD113 for 10 days or Atomoxetine for 10 days. Participants will return 1 week 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
- •Between 25 to 65 years of age, inclusive, at the Screening Visit.
- •AHI 10 to 50 (hypopneas defined by 4% oxygen desaturation)
- •History of hypertension or blood pressure at Visit 1 ≥130/80 mmHg
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
AD113
Two oral capsules administered before bed
干预措施: AD113 (Drug)
Atomoxetine
Two oral capsules administered before bed
干预措施: Atomoxetine (Drug)
结局指标
主要结局
Change in hypoxic burden (HB, total area under the respiratory event-related desaturation curve)
时间窗: 10 days of treatment per crossover arm
Change in HB for AD113 vs. atomoxetine measured by polysomnography atomoxetine
次要结局
- Change in Apnea-Hypopnea Index (AHI, average number of events for every hour of sleep)(10 days of treatment per crossover arm)