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Enrolling by invitation Phase 3 Interventional Accepts healthy volunteers

Continuation Protocol for Obstructive Sleep Apnea (OSA)

ClinicalTrials.gov ID: NCT06566820

Public ClinicalTrials.gov record NCT06566820. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 19, 2026, 10:04 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06566820
Recruitment status
Enrolling by invitation
Study type
Interventional
Phase
Phase 3
Lead sponsor
Apnimed
Industry
Enrollment
1,280 participants

Conditions and interventions

Conditions

Interventions

Drug

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Accepts healthy volunteers

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Jul 3, 2024 (Actual)
Primary completion
Jun 30, 2026 (Estimated)
Completion
Jun 30, 2026 (Estimated)
Last update posted
May 13, 2025

2024 – 2026

United States locations

U.S. sites
93
U.S. states
29
U.S. cities
83
Facility City State ZIP Site status
Sleep Disorders Center of America Birmingham Alabama 35213 —
The University of Alabama/Institute for Rural Health Research Tuscaloosa Alabama 35401 —
Chandler Clinical Trials Chandler Arizona 85224 —
Desert Clinical Reserach, LLC/CCT Research Mesa Arizona 85213 —
Foothills Research Center/CCT Research Phoenix Arizona 85044 —
Fiel Family and Sports Medicine/CCT Research Tempe Arizona 85283 —
Noble Clinical Research Tucson Arizona 85704 —
Preferred Research Partners, Inc. Little Rock Arkansas 72211 —
Orange County Research Institute Anaheim California 92801 —
Core Healthcare Group Cerritos California 90703 —
Exalt Clinical Research, Inc. Chula Vista California 91910 —
Collaborative Neuroscience Research, LLC Los Alamitos California 90720 —
Santa Monica Clinical Trials Los Angeles California 90025 —
Empire Clinical Research Pomona California 91767 —
Probe Clinical Research Corporation Riverside California 92501 —
Pacific Research Network San Diego California 92103 —
TriValley Sleep Center San Ramon California 94583 —
SDS Clinical Trials, Inc. Santa Ana California 92705 —
Providere Research Inc. West Covina California 91790 —
Mountain View Clinical Research, Inc. Denver Colorado 80209 —
Meris Clinical Research Brandon Florida 33511 —
Teradan Clinical Trials Brandon Florida 33511 —
St. Francis Medical Institute Clearwater Florida 33765 —
Nouvelle Clinical Research Cutler Bay Florida 33189 —
Arrow Clinical Trials Daytona Beach Florida 32117 —
Canvas Clinical Research Lake Worth Florida 33467 —
Florida Lung & Sleep Associates Lehigh Acres Florida 33971 —
Ivetmar Medical Group, LLC Miami Florida 33155 —
Advanced Medical Research Institute Miami Florida 33174 —
PharmaDev Clinical Research Institute, LLC Miami Florida 33176 —
Flourish Research Miami Florida 33186 —
Renstar Medical Research Ocala Florida 34470 —
Clinical Neuroscience Solutions, Inc. Orlando Florida 32801 —
JSV Clinical Research Study Inc. Tampa Florida 33634 —
Palm Beach Research Center West Palm Beach Florida 33409 —
Central Florida Pediatric Sleep Disorders d/b/a Florida Pediatric Institute, LLC Winter Park Florida 32789 —
Clinical Site Partners, LLC dba Flourish Research Winter Park Florida 32789 —
Neurotrials Research Inc Atlanta Georgia 30328 —
Atlanta Center for Medical Research Atlanta Georgia 30331 —
CenExel iResearch, LLC Decatur Georgia 30030 —
Georgia Neurology and Sleep Medicine Associates Suwanee Georgia 30024 —
Medster Research Valdosta Georgia 31605 —
St. Luke's Idaho Pulmonary Associates - Meridian Clinic Meridian Idaho 83642 —
Chicago Research Center, Inc. Chicago Illinois 60634 —
University of Kansas Medical Center Kansas City Kansas 66160 —
Advanced ENT and Allergy Louisville Kentucky 40220 —
Centennial Medical Group Research Department Columbia Maryland 21045 —
Sleep Disorders Centers of the Mid-Atlantic Glen Burnie Maryland 21061 —
Velocity Clinical Research Rockville Maryland 20854 —
Neurocare, Inc. Newton Massachusetts 02459 —
Infinity Medical Research North Dartmouth Massachusetts 02747 —
Baystate Clinical Trials Unit Springfield Massachusetts 01107 —
University of Michigan Clinical Research Unit Ann Arbor Michigan 48109 —
Revive Research Institute, Inc. Lathrup Village Michigan 48076 —
Henry Ford Medical Center - Columbus Novi Michigan 48377 —
Clinical Neurophysiology Services PC Sterling Heights Michigan 48314 —
Sleep Medicine and Research Center, St. Luke's Hospital Chesterfield Missouri 63017 —
Healthcare Research Network Hazelwood Missouri 63042 —
Clayton Sleep Institute, LLC St Louis Missouri 63123 —
Henderson Clinical Trials Henderson Nevada 89052 —
Las Vegas Clinical Trials, LLC North Las Vegas Nevada 89030 —
Clinilabs Drug Development Corporation Eatontown New Jersey 07724 —
Sleep Dynamics Neptune City New Jersey 07753 —
Maimonides Sleep Arts & Sciences Albuquerque New Mexico 87107 —
Northwell Health New Hyde Park New York 11042 —
Research Carolina Elite Denver North Carolina 28037 —
Clinical Research of Gastonia Gastonia North Carolina 28054 —
Peters Medical Research LLC High Point North Carolina 27260 —
Advanced Respiratory and Sleep Medicine Huntersville North Carolina 28078 —
Coastal Carolina Health Care, P.A. Pulmonary and Sleep Medicine New Bern North Carolina 28562 —
Accellacare Wilmington North Carolina 28412 —
Lillestol Research Fargo North Dakota 58104 —
NeuroScience Research Center, LLC Canton Ohio 44718 —
CTI Clinical Research Center Cincinnati Ohio 45212 —
Intrepid Research, LLC Cincinnati Ohio 45245 —
Northwest Research Center Portland Oregon 97202 —
Abington Neurological Associates Abington Pennsylvania 19001 —
Respiratory Specialists Wyomissing Pennsylvania 19610 —
Lowcountry Lung and Critical Care, PA Charleston South Carolina 29406 —
Tribe Clinical Research, LLC Greenville South Carolina 29607 —
Velocity Clinical Research, Greenville Greenville South Carolina 29615 —
OnSite Clinical Solutions, LLC Rock Hill South Carolina 29732 —
Chattanooga Research & Medicine Chattanooga Tennessee 37404 —
Clinical Neuroscience Solutions, Inc. Memphis Tennessee 38119 —
FutureSearch Trials of Neurology Austin Texas 78731 —
FutureSearch Trials of Dallas Dallas Texas 75231 —
Memorial Hermann Village Houston Texas 77043 —
Houston Clinical Research Associates Houston Texas 77070 —
Huntsville Research Institute Huntsville Texas 77340 —
Sleep Therapy and Research Center San Antonio Texas 78229 —
Element Research Group San Antonio Texas 78258 —
South Ogden Family Medicine/CCT Research South Ogden Utah 84405 —
Sleep Disorder Center of the Mid-Atlantic Vienna Virginia 22182 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 6 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06566820, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted May 13, 2025 · Synced Oct 19, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT06566820 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →