Phase 2 Randomized, Double Blind, Placebo-Controlled, Single-Dose, 3-Period Crossover Study to Evaluate the Efficacy of AD182, and AD504 in Obstructive Sleep Apnea

Apnimed1 个研究点分布在 1 个国家目标入组 15 人开始时间: 2020年12月1日最近更新: 2022年9月2日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方
入组人数: 15
试验地点: 1
主要终点: Apnea-Hypopnea Index (AHI, average number of events for every hour of sleep)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a randomized, 3-period, placebo-controlled, crossover study to examine the efficacy and safety of AD182 and AD504 versus placebo in patients with obstructive sleep apnea.

详细描述

The study is designed to examine the efficacy and safety of AD182 to treat obstructive sleep apnea. The study is a three-period single-dose randomized crossover design in which patients will undergo overnight polysomnographic (PSG) testing with dosing of one of the following 3 treatments: AD182, AD504, or Placebo. 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

•Male or female between 25 and 65 years of age, inclusive, at the time of the screening visit
•AHI 10 to 55 events/h 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.