Continuation Protocol for Obstructive Sleep Apnea (OSA)

Enrolling by invitation · Phase 3

Conditions studied: OSA

In brief

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 label continuation protocol enrolling qualifying participants who completed one of the parent Phase 3 double-blind placebo-controlled studies, APC-APN-304 or APC-APN-305.

Key facts

Study ID

NCT06566820

Run by

Apnimed

People needed

1280

Starts

2024-07-03

Expected to finish

2026-06-30

Last updated by the study team

2025-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Completion of APC-APN-304 without permanent discontinuation of IMP.
• Completion of APC-APN-305 without permanent discontinuation of IMP.

You may not qualify if…

• 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.

Where it is running

• The University of Alabama/Institute for Rural Health Research — Tuscaloosa, Alabama, United States
• Chandler Clinical Trials — Chandler, Arizona, United States
• Desert Clinical Reserach, LLC/CCT Research — Mesa, Arizona, United States
• Foothills Research Center/CCT Research — Phoenix, Arizona, United States
• Fiel Family and Sports Medicine/CCT Research — Tempe, Arizona, United States
• Noble Clinical Research — Tucson, Arizona, United States
• Preferred Research Partners, Inc. — Little Rock, Arkansas, United States
• Orange County Research Institute — Anaheim, California, United States
• Core Healthcare Group — Cerritos, California, United States
• Exalt Clinical Research, Inc. — Chula Vista, California, United States
• Collaborative Neuroscience Research, LLC — Los Alamitos, California, United States
• Santa Monica Clinical Trials — Los Angeles, California, United States
• Empire Clinical Research — Pomona, California, United States
• Probe Clinical Research Corporation — Riverside, California, United States
• Pacific Research Network — San Diego, California, United States
• TriValley Sleep Center — San Ramon, California, United States
• SDS Clinical Trials, Inc. — Santa Ana, California, United States
• Providere Research Inc. — West Covina, California, United States
• Mountain View Clinical Research, Inc. — Denver, Colorado, United States
• Meris Clinical Research — Brandon, Florida, United States
• Teradan Clinical Trials — Brandon, Florida, United States
• St. Francis Medical Institute — Clearwater, Florida, United States
• Nouvelle Clinical Research — Cutler Bay, Florida, United States
• Arrow Clinical Trials — Daytona Beach, Florida, United States
• Sleep Disorders Center of America — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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