Continuation Protocol for Obstructive Sleep Apnea (OSA)
Key facts
- Where
- Kelowna, Markham, Montreal, Ottawa, and Toronto, CanadaSee the 6 sites
- Phase
- Phase 3
Where in Canada
- Medical Arts Health Research GroupKelowna, CanadaNo longer taking part
- AMNDX Inc.Markham, CanadaNo longer taking part
- McGill University Health CentreMontreal, CanadaNo longer taking part
- West Ottawa Sleep CentreOttawa, CanadaNo longer taking part
- Canadian Phase Onward Inc.Toronto, CanadaNo longer taking part
- Jodha Tishon Inc.Toronto, CanadaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Apnimed
- Trial code
- NCT06566820
- Record updated
- 13 May 2025
- Original description
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.Read full original descriptionShow less
A Phase 3 Open Label Continuation Protocol of a Fixed Dose Combination of Aroxybutynin and Atomoxetine (AD109) in Obstructive Sleep Apnea
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.
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 concomitant therapies; Participants are excluded from the study if participation would be considered unsafe by the investigator based on the individual's current status.