Status:
ENROLLING_BY_INVITATION
Continuation Protocol for Obstructive Sleep Apnea (OSA)
Lead Sponsor:
Apnimed
Conditions:
OSA
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The combination drug composed of aroxybutynin and atomoxetine, designated AD109, is being developed by Apnimed for the treatment of obstructive sleep apnea (OSA). The present study is a Phase 3 open l...
Eligibility Criteria
Inclusion
- Completion of APC-APN-304 without permanent discontinuation of IMP.
- Completion of APC-APN-305 without permanent discontinuation of IMP.
Exclusion
- Participants are excluded from the study if participation would be considered unsafe by the investigator based on the individual's current status.
- Participants are excluded from the study if participation would be considered unsafe by the investigator based on concomitant therapies.
Key Trial Info
Start Date :
July 3 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
1280 Patients enrolled
Trial Details
Trial ID
NCT06566820
Start Date
July 3 2024
End Date
June 30 2026
Last Update
May 13 2025
Active Locations (99)
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1
Sleep Disorders Center of America
Birmingham, Alabama, United States, 35213
2
The University of Alabama/Institute for Rural Health Research
Tuscaloosa, Alabama, United States, 35401
3
Chandler Clinical Trials
Chandler, Arizona, United States, 85224
4
Desert Clinical Reserach, LLC/CCT Research
Mesa, Arizona, United States, 85213