Crossover Trial of AD109 in Obstructive Sleep Apnea

• Status: Completed
• Trial end date: 2021-05-28
• Target enrollment: 0
• Participant gender: All

Summary

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.

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

Details

• Lead Sponsor: Apnimed
• Treatments: Atomoxetine Hydrochloride; Oxybutynin

Criteria

Inclusion Criteria:

• 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

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.