NCT06566820

Continuation Protocol for Obstructive Sleep Apnea (OSA)

A Phase 3 Open Label Continuation Protocol of a Fixed Dose Combination of Aroxybutynin and Atomoxetine (AD109) in Obstructive Sleep Apnea

• Status: Enrolling By Invitation
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,280 (estimated)
• Sponsor: Apnimed · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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 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.

Conditions

• OSA

Interventions

Type	Name	Description
DRUG	Aroxybutynin and Atomoxetine	Fixed Dose Combination

Timeline

• Start date: 2024-07-03
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2024-08-22
• Last updated: 2025-05-13

Locations

99 sites across 2 countries: United States, Canada

Regulatory

• FDA-regulated drug study