Parallel Arm Trial of AD109 and AD504 In Patients With OSA

• Status: Not yet recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a phase 2 randomized double-blind placebo-controlled parallel-arm dose finding study to compare fixed dose combinations of AD109 and AD504 to atomoxetine or placebo in Obstructive Sleep Apnea.

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

Details

• Lead Sponsor: Apnimed
• Treatments: Atomoxetine Hydrochloride

Criteria

Inclusion Criteria:

• Between 18 to 65 years of age for men and 18-75 for women, inclusive, at the Screening Visit.

• Mean AHI 10 to 45 events/h, inclusive

• PGI-S: >1

Exclusion Criteria:

• Current clinically significant sleep disorder other than OSA

• Clinically significant craniofacial malformation.

• Clinically significant cardiac disease (e.g. rhythm disturbances, coronary artery disease or heart failure or hypertension requiring more than 2 medications for control).

• Participants with a history of using devices for OSA treatment, including CPAP, oral or nasal devices, or positional devices, may enroll as long as the devices have not been used for at least 2 weeks prior to first PSG and are not used during participation in the study