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NCT06566820 | ENROLLING BY INVITATION | OSA


Continuation Protocol for Obstructive Sleep Apnea (OSA)
Sponsor:

Apnimade

Brief 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.

Condition or disease

OSA

Intervention/treatment

Aroxybutynin and Atomoxetine

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 1280 participants
Masking : NONE
Primary Purpose : OTHER
Official Title : A Phase 3 Open Label Continuation Protocol of a Fixed Dose Combination of Aroxybutynin and Atomoxetine (AD109) in Obstructive Sleep Apnea
Actual Study Start Date : 2024-07-03
Estimated Primary Completion Date : 2026-06-30
Estimated Study Completion Date : 2026-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
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.

Continuation Protocol for Obstructive Sleep Apnea (OSA)

Location Details

NCT06566820


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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations


Not yet recruiting

United States, alabama

Sleep Disorders Center of America

Birmingham, alabama, United States, 35213

Not yet recruiting

United States, alabama

The University of Alabama/Institute for Rural Health Research

Tuscaloosa, alabama, United States, 35401

Not yet recruiting

United States, Arizona

Desert Clinical Reserach, LLC/CCT Research

Mesa, arizona, United States, 85213

Not yet recruiting

United States, Arizona

Foothills Research Center/CCT Research

Phoenix, arizona, United States, 85044

Not yet recruiting

United States, Arizona

Fiel Family and Sports Medicine/CCT Research

Tempe, arizona, United States, 85283

Not yet recruiting

United States, Arkansas

Preferred Research Partners, Inc.

Little Rock, arkansas, United States, 72211

Not yet recruiting

United States, California

Orange County Research Institute

Anaheim, California, United States, 92801

Not yet recruiting

United States, California

Core Healthcare Group

Cerritos, California, United States, 90703

Not yet recruiting

United States, California

Exalt Clinical Research, Inc.

Chula Vista, California, United States, 91910

Not yet recruiting

United States, California

Collaborative Neuroscience Research, LLC

Los Alamitos, California, United States, 90720

Not yet recruiting

United States, California

Empire Clinical Research

Pomona, California, United States, 91767

Not yet recruiting

United States, California

Probe Clinical Research Corporation

Riverside, California, United States, 92501

Not yet recruiting

United States, California

Pacific Research Network

San Diego, California, United States, 92103

Not yet recruiting

United States, California

TriValley Sleep Center

San Ramon, California, United States, 94583

Not yet recruiting

United States, California

Providere Research Inc.

West Covina, California, United States, 91790

Not yet recruiting

United States, Florida

Teradan Clinical Trials

Brandon, florida, United States, 33511

Not yet recruiting

United States, Florida

Nouvelle Clinical Research

Cutler Bay, florida, United States, 33189

Not yet recruiting

United States, Florida

Arrow Clinical Trials

Daytona Beach, florida, United States, 32117

Not yet recruiting

United States, Florida

Canvas Clinical Research

Lake Worth, florida, United States, 33467

Not yet recruiting

United States, Florida

Florida Lung & Sleep Associates

Lehigh Acres, florida, United States, 33971

Not yet recruiting

United States, Florida

Advanced Medical Research Institute

Miami, florida, United States, 33174

Not yet recruiting

United States, Florida

PharmaDev Clinical Research Institute, LLC

Miami, florida, United States, 33176

Not yet recruiting

United States, Florida

Flourish Research

Miami, florida, United States, 33186

Not yet recruiting

United States, Florida

Renstar Medical Research

Ocala, florida, United States, 34470

Not yet recruiting

United States, Florida

Clinical Neuroscience Solutions, Inc.

Orlando, florida, United States, 32801

Not yet recruiting

United States, Florida

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

Winter Park, florida, United States, 32789

Not yet recruiting

United States, Florida

Clinical Site Partners, LLC dba Flourish Research

Winter Park, florida, United States, 32789

Not yet recruiting

United States, Georgia

Neurotrials Research Inc

Atlanta, Georgia, United States, 30328

Not yet recruiting

United States, Georgia

Atlanta Center for Medical Research

Atlanta, Georgia, United States, 30331

Not yet recruiting

United States, Georgia

Georgia Neurology and Sleep Medicine Associates

Suwanee, Georgia, United States, 30024

Not yet recruiting

United States, Georgia

Medster Research

Valdosta, Georgia, United States, 31605

Not yet recruiting

United States, Illinois

Chicago Research Center, Inc.

Chicago, Illinois, United States, 60634

Not yet recruiting

United States, Kentucky

Advanced ENT and Allergy

Louisville, Kentucky, United States, 40220

Not yet recruiting

United States, Maryland

Centennial Medical Group Research Department

Columbia, Maryland, United States, 21045

Not yet recruiting

United States, Maryland

Sleep Disorders Centers of the Mid-Atlantic

Glen Burnie, Maryland, United States, 21061

Not yet recruiting

United States, Maryland

Velocity Clinical Research

Rockville, Maryland, United States, 20854

Not yet recruiting

United States, Massachusetts

Infinity Medical Research

North Dartmouth, Massachusetts, United States, 02747

Not yet recruiting

United States, road cancer

Revive Research Institute, Inc.

Lathrup Village, road cancer, United States, 48076

Not yet recruiting

United States, road cancer

Clinical Neurophysiology Services PC

Sterling Heights, road cancer, United States, 48314

Not yet recruiting

United States, Missouri

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

Chesterfield, Missouri, United States, 63017

Not yet recruiting

United States, Missouri

Healthcare Research Network

Hazelwood, Missouri, United States, 63042

Not yet recruiting

United States, Missouri

Clayton Sleep Institute, LLC

St. Louis, Missouri, United States, 63123

Not yet recruiting

United States, Nevada

Henderson Clinical Trials

Henderson, Nevada, United States, 89052

Not yet recruiting

United States, Nevada

Las Vegas Clinical Trials, LLC

North Las Vegas, Nevada, United States, 89030

Not yet recruiting

United States, New Jersey

Clinilabs Drug Development Corporation

Eatontown, New Jersey, United States, 07724

Not yet recruiting

United States, New Jersey

Sleep Dynamics

Neptune, New Jersey, United States, 07753

Not yet recruiting

United States, New Mexico

Maimonides Sleep Arts & Sciences

Albuquerque, New Mexico, United States, 87107

Not yet recruiting

United States, North Carolina

Research Carolina Elite

Denver, North Carolina, United States, 28037

Not yet recruiting

United States, North Carolina

Advanced Respiratory and Sleep Medicine

Huntersville, North Carolina, United States, 28078

Not yet recruiting

United States, North Carolina

Accellacare

Wilmington, North Carolina, United States, 28412

Not yet recruiting

United States, North Dakota

Small Chair Research

Fargo, North Dakota, United States, 58104

Not yet recruiting

United States, Ohio

CTI Clinical Research Center

Cincinnati, Ohio, United States, 45212

Not yet recruiting

United States, Ohio

Intrepid Research, LLC

Cincinnati, Ohio, United States, 45245

Not yet recruiting

United States, Pennsylvania

Abington Neurological Associates

Abington, Pennsylvania, United States, 19001

Not yet recruiting

United States, Pennsylvania

Respiratory Specialists

Wyomissing, Pennsylvania, United States, 19610

Not yet recruiting

United States, South Carolina

Tribe Clinical Research, LLC

Greenville, South Carolina, United States, 29607

Not yet recruiting

United States, South Carolina

Velocity Clinical Research, Greenville

Greenville, South Carolina, United States, 29615

Not yet recruiting

United States, South Carolina

OnSite Clinical Solutions, LLC

Rock Hill, South Carolina, United States, 29732

Not yet recruiting

United States, Texas

FutureSearch Trials of Neurology

Austin, Texas, United States, 78731

Not yet recruiting

United States, Texas

FutureSearch Trials of Dallas

dallas, Texas, United States, 75231

Not yet recruiting

United States, Texas

Memorial Hermann Village

Houston, Texas, United States, 77043

Not yet recruiting

United States, Texas

Houston Clinical Research Associates

Houston, Texas, United States, 77070

Not yet recruiting

United States, Texas

Huntsville Research Institute

Huntsville, Texas, United States, 77340

Not yet recruiting

United States, Texas

Element Research Group

Saint Anthony, Texas, United States, 78258

Not yet recruiting

United States, Utah

South Ogden Family Medicine/CCT Research

South Ogden, Utah, United States, 84405

Not yet recruiting

Canada, British Columbia

Medical Arts Health Research Group

Kelowna, British Columbia, Canada, VIY 4N7

Not yet recruiting

Canada, Ontario

AMNDX Inc

Markham, Ontario, Canada, L3R 1A3

Not yet recruiting

Canada, Ontario

Canadian Phase Onward Inc.

Toronto, Ontario, Canada, oe3h 0k2

Not yet recruiting

Canada, Ontario

Warrior Tition, Ins.

Toronto, Ontario, Canada, Shame on

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