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Continuation Protocol for Obstructive Sleep Apnea (OSA)

NCT06566820 · Status: ENROLLING_BY_INVITATION · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1280

Last updated 2025-05-13

No results posted yet for this study

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

DRUG

Aroxybutynin and Atomoxetine

Fixed Dose Combination

Sponsors & Collaborators

  • Apnimed

    lead INDUSTRY

Principal Investigators

  • Ron Farkas, MD · Apnimed

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-03
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06566820 on ClinicalTrials.gov