Continuation Protocol for Obstructive Sleep Apnea (OSA)

NCT ID: NCT06566820

Last Updated: 2025-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE3

Total Enrollment

1280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-03

Study Completion Date

2026-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

OSA

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

AD109

Open Label AD109

Group Type EXPERIMENTAL

Aroxybutynin and Atomoxetine

Intervention Type DRUG

Fixed Dose Combination

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Aroxybutynin and Atomoxetine

Fixed Dose Combination

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

AD109

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Apnimed

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ron Farkas, MD

Role: STUDY_DIRECTOR

Apnimed

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Sleep Disorders Center of America

Birmingham, Alabama, United States

Site Status

The University of Alabama/Institute for Rural Health Research

Tuscaloosa, Alabama, United States

Site Status

Chandler Clinical Trials

Chandler, Arizona, United States

Site Status

Desert Clinical Reserach, LLC/CCT Research

Mesa, Arizona, United States

Site Status

Foothills Research Center/CCT Research

Phoenix, Arizona, United States

Site Status

Fiel Family and Sports Medicine/CCT Research

Tempe, Arizona, United States

Site Status

Noble Clinical Research

Tucson, Arizona, United States

Site Status

Preferred Research Partners, Inc.

Little Rock, Arkansas, United States

Site Status

Orange County Research Institute

Anaheim, California, United States

Site Status

Core Healthcare Group

Cerritos, California, United States

Site Status

Exalt Clinical Research, Inc.

Chula Vista, California, United States

Site Status

Collaborative Neuroscience Research, LLC

Los Alamitos, California, United States

Site Status

Santa Monica Clinical Trials

Los Angeles, California, United States

Site Status

Empire Clinical Research

Pomona, California, United States

Site Status

Probe Clinical Research Corporation

Riverside, California, United States

Site Status

Pacific Research Network

San Diego, California, United States

Site Status

TriValley Sleep Center

San Ramon, California, United States

Site Status

SDS Clinical Trials, Inc.

Santa Ana, California, United States

Site Status

Providere Research Inc.

West Covina, California, United States

Site Status

Mountain View Clinical Research, Inc.

Denver, Colorado, United States

Site Status

Meris Clinical Research

Brandon, Florida, United States

Site Status

Teradan Clinical Trials

Brandon, Florida, United States

Site Status

St. Francis Medical Institute

Clearwater, Florida, United States

Site Status

Nouvelle Clinical Research

Cutler Bay, Florida, United States

Site Status

Arrow Clinical Trials

Daytona Beach, Florida, United States

Site Status

Canvas Clinical Research

Lake Worth, Florida, United States

Site Status

Florida Lung & Sleep Associates

Lehigh Acres, Florida, United States

Site Status

Ivetmar Medical Group, LLC

Miami, Florida, United States

Site Status

Advanced Medical Research Institute

Miami, Florida, United States

Site Status

PharmaDev Clinical Research Institute, LLC

Miami, Florida, United States

Site Status

Flourish Research

Miami, Florida, United States

Site Status

Renstar Medical Research

Ocala, Florida, United States

Site Status

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States

Site Status

JSV Clinical Research Study Inc.

Tampa, Florida, United States

Site Status

Palm Beach Research Center

West Palm Beach, Florida, United States

Site Status

Central Florida Pediatric Sleep Disorders d/b/a Florida Pediatric Institute, LLC

Winter Park, Florida, United States

Site Status

Clinical Site Partners, LLC dba Flourish Research

Winter Park, Florida, United States

Site Status

Neurotrials Research Inc

Atlanta, Georgia, United States

Site Status

Atlanta Center for Medical Research

Atlanta, Georgia, United States

Site Status

CenExel iResearch, LLC

Decatur, Georgia, United States

Site Status

Georgia Neurology and Sleep Medicine Associates

Suwanee, Georgia, United States

Site Status

Medster Research

Valdosta, Georgia, United States

Site Status

St. Luke's Idaho Pulmonary Associates - Meridian Clinic

Meridian, Idaho, United States

Site Status

Chicago Research Center, Inc.

Chicago, Illinois, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Advanced ENT and Allergy

Louisville, Kentucky, United States

Site Status

Centennial Medical Group Research Department

Columbia, Maryland, United States

Site Status

Sleep Disorders Centers of the Mid-Atlantic

Glen Burnie, Maryland, United States

Site Status

Velocity Clinical Research

Rockville, Maryland, United States

Site Status

Neurocare, Inc.

Newton, Massachusetts, United States

Site Status

Infinity Medical Research

North Dartmouth, Massachusetts, United States

Site Status

Baystate Clinical Trials Unit

Springfield, Massachusetts, United States

Site Status

University of Michigan Clinical Research Unit

Ann Arbor, Michigan, United States

Site Status

Revive Research Institute, Inc.

Lathrup Village, Michigan, United States

Site Status

Henry Ford Medical Center - Columbus

Novi, Michigan, United States

Site Status

Clinical Neurophysiology Services PC

Sterling Heights, Michigan, United States

Site Status

Sleep Medicine and Research Center, St. Luke's Hospital

Chesterfield, Missouri, United States

Site Status

Healthcare Research Network

Hazelwood, Missouri, United States

Site Status

Clayton Sleep Institute, LLC

St Louis, Missouri, United States

Site Status

Henderson Clinical Trials

Henderson, Nevada, United States

Site Status

Las Vegas Clinical Trials, LLC

North Las Vegas, Nevada, United States

Site Status

Clinilabs Drug Development Corporation

Eatontown, New Jersey, United States

Site Status

Sleep Dynamics

Neptune City, New Jersey, United States

Site Status

Maimonides Sleep Arts & Sciences

Albuquerque, New Mexico, United States

Site Status

Northwell Health

New Hyde Park, New York, United States

Site Status

Research Carolina Elite

Denver, North Carolina, United States

Site Status

Clinical Research of Gastonia

Gastonia, North Carolina, United States

Site Status

Peters Medical Research LLC

High Point, North Carolina, United States

Site Status

Advanced Respiratory and Sleep Medicine

Huntersville, North Carolina, United States

Site Status

Coastal Carolina Health Care, P.A. Pulmonary and Sleep Medicine

New Bern, North Carolina, United States

Site Status

Accellacare

Wilmington, North Carolina, United States

Site Status

Lillestol Research

Fargo, North Dakota, United States

Site Status

NeuroScience Research Center, LLC

Canton, Ohio, United States

Site Status

CTI Clinical Research Center

Cincinnati, Ohio, United States

Site Status

Intrepid Research, LLC

Cincinnati, Ohio, United States

Site Status

Northwest Research Center

Portland, Oregon, United States

Site Status

Abington Neurological Associates

Abington, Pennsylvania, United States

Site Status

Respiratory Specialists

Wyomissing, Pennsylvania, United States

Site Status

Lowcountry Lung and Critical Care, PA

Charleston, South Carolina, United States

Site Status

Tribe Clinical Research, LLC

Greenville, South Carolina, United States

Site Status

Velocity Clinical Research, Greenville

Greenville, South Carolina, United States

Site Status

OnSite Clinical Solutions, LLC

Rock Hill, South Carolina, United States

Site Status

Chattanooga Research & Medicine

Chattanooga, Tennessee, United States

Site Status

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, United States

Site Status

FutureSearch Trials of Neurology

Austin, Texas, United States

Site Status

FutureSearch Trials of Dallas

Dallas, Texas, United States

Site Status

Memorial Hermann Village

Houston, Texas, United States

Site Status

Houston Clinical Research Associates

Houston, Texas, United States

Site Status

Huntsville Research Institute

Huntsville, Texas, United States

Site Status

Sleep Therapy and Research Center

San Antonio, Texas, United States

Site Status

Element Research Group

San Antonio, Texas, United States

Site Status

South Ogden Family Medicine/CCT Research

South Ogden, Utah, United States

Site Status

Sleep Disorder Center of the Mid-Atlantic

Vienna, Virginia, United States

Site Status

Medical Arts Health Research Group

Kelowna, British Columbia, Canada

Site Status

AMNDX Inc

Markham, Ontario, Canada

Site Status

West Ottawa Sleep Centre

Ottawa, Ontario, Canada

Site Status

Canadian Phase Onward Inc.

Toronto, Ontario, Canada

Site Status

Jodha Tishon, Inc.

Toronto, Ontario, Canada

Site Status

McGill University Health Centre

Montreal, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Canada

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

APC-APN-306

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Atomoxetine and DAW2022 on OSA Severity
NCT05350215 UNKNOWN PHASE1/PHASE2
Atomoxetine Effects in Humans
NCT00607568 COMPLETED PHASE1/PHASE2
Effects of Atomoxetine Treatment in Humans
NCT00611936 COMPLETED PHASE1/PHASE2
Long-Term, Open Label Atomoxetine Study
NCT00190684 COMPLETED PHASE3