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Completed NCT05071612

Parallel Arm Trial of AD109 and AD504 In Patients With OSA

Conditions: OSA - Obstructive Sleep Apnea

Sex: All
Ages: 18 Years – 75 Years
Healthy volunteers: No
Phase: PHASE2
Enrollment: 294
Sponsor: Apnimed

Location: Santa Monica Clinical Trials Los Angeles California

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.

Eligibility 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 * BMI between 18.5 and 38 kg/m2 for men and 40 kg/m2 for women, inclusive. 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05071612). StuddyBuddy aggregates publicly available trial information.