AD109 for Obstructive Sleep Apnea
Recruiting at 93 trial locations
RF
LT
Overseen ByLuigi Taranto, MD, MD
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Waitlist Available
Sponsor: Apnimed
No Placebo Group
Pivotal Trial (Near Approval)
Prior Safety Data
Trial Summary
What is the purpose of this trial?
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.
Research Team
RF
Ron Farkas, MD
Principal Investigator
Apnimed
Eligibility Criteria
This trial is for individuals who have completed one of the parent Phase 3 studies, APC-APN-304 or APC-APN-305, and are diagnosed with obstructive sleep apnea (OSA). Specific eligibility details are not provided but typically include meeting certain health standards.Inclusion Criteria
Completion of APC-APN-304 without permanent discontinuation of IMP
Completion of APC-APN-305 without permanent discontinuation of IMP
Exclusion Criteria
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.
Treatment Details
Interventions
- AD109 (Combination Drug)
Trial OverviewThe study tests a combination drug called AD109, made up of aroxybutynin and atomoxetine. It's an open label continuation from previous double-blind studies aimed at treating OSA in those who've already participated.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: AD109Experimental Treatment1 Intervention
Open Label AD109
Find a Clinic Near You
Who Is Running the Clinical Trial?
Apnimed
Lead Sponsor
Trials
17
Recruited
3,400+