Crossover Trial of AD182 and AD504 in Obstructive Sleep Apnea

• Status: Completed
• Trial end date: 2021-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Apnimed

Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.