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