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COMPLETED
NCT05813275
PHASE3

Parallel-Arm Study to Compare AD109 to Placebo With Patients With OSA (SynAIRgy Study)

Sponsor: Apnimed

View on ClinicalTrials.gov

Summary

This is a Phase 3 Randomized Double-Blind Placebo-Controlled 6-month Parallel-Arm Study to Compare a Fixed Dose Combination of AD109 to Placebo in Obstructive Sleep Apnea.

Official title: Phase 3 Randomized Double-Blind Placebo-Controlled 6-month Parallel-Arm Study to Compare a Fixed Dose Combination of Aroxybutynin/Atomoxetine (AD109) to Placebo in Obstructive Sleep Apnea (SynAIRgy Study)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

646

Start Date

2023-09-16

Completion Date

2025-03-14

Last Updated

2026-09-11

Healthy Volunteers

No

Conditions

Interventions

DRUG

AD109

Aroxybutynin 2.5 mg/atomoxetine 75 mg tablet, administered orally once daily at bedtime (Weeks 2-26). Week 1 run-in: aroxybutynin 2.5 mg/atomoxetine 37.5 mg tablet.

DRUG

Placebo

Matching placebo tablet administered orally once daily at bedtime for 26 weeks, with run-in and target dose matched to active arm packaging

Locations (73)

Alabama Neurology & Sleep Medicine

Tuscaloosa, Alabama, United States

Desert Clinical Research - CCT Research

Mesa, Arizona, United States

Foothills Research Center - CCT Research

Phoenix, Arizona, United States

Fiel Family Sports Medicine - PC CCT Research

Tempe, Arizona, United States

Noble Clinical Research

Tucson, Arizona, United States

Preferred Research Partners, Inc.

Little Rock, Arkansas, United States

Orange County Research Institute

Anaheim, California, United States

North County Neurology Associates

Carlsbad, California, United States

Core Healthcare Group

Cerritos, California, United States

Exalt Clinical Research

Chula Vista, California, United States

Catalina Research Institute

Montclair, California, United States

Probe Clinical Research Corporation

Riverside, California, United States

Pacific Research Network

San Diego, California, United States

Sleep Medicine Specialists of California

San Ramon, California, United States

SDS Clinical Trials Inc.

Santa Ana, California, United States

Provideré Research Inc.

West Covina, California, United States

Meris Clinical Research

Brandon, Florida, United States

Nouvelle Clinical Research

Cutler Bay, Florida, United States

Accel Research Sites

DeLand, Florida, United States

Research Centers of America, LLC

Hollywood, Florida, United States

Canvas Clinical Research

Lake Worth, Florida, United States

Florida Lung and Sleep Associates

Lehigh Acres, Florida, United States

Advanced Medical Research Institute

Miami, Florida, United States

Clinical Site Partners

Miami, Florida, United States

Clinical Neuroscience Solutions, Inc - Orlando

Orlando, Florida, United States

JSV Clinical Research Study Inc

Tampa, Florida, United States

Florida Pediatric Research Institute

Winter Park, Florida, United States

Atlanta Center for Medical Research, LLC

Atlanta, Georgia, United States

NeuroTrials Research

Atlanta, Georgia, United States

Georgia Neurology and Sleep Medicine Assoc

Suwanee, Georgia, United States

Javarra Inc-Privia Medical Group

Thomasville, Georgia, United States

St. Lukes Clinic - Idaho Pulmonary Associates

Meridian, Idaho, United States

Chicago Research Center Inc

Chicago, Illinois, United States

OSF HealthCare Saint Francis Medical Center

Peoria, Illinois, United States

The University of Kansas Medical Center

Kansas City, Kansas, United States

Advanced ENT and Allergy

Louisville, Kentucky, United States

Centennial Medical Group

Elkridge, Maryland, United States

Infinity Medical Research

North Dartmouth, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States

Revive Research Institute

Lathrup Village, Michigan, United States

Las Vegas Clinical Trials

North Las Vegas, Nevada, United States

Neurology Specialists of Monmouth County

West Long Branch, New Jersey, United States

Javara Inc - Tryon Medical Partners PLCC

Charlotte, North Carolina, United States

Research Carolina Elite

Denver, North Carolina, United States

Peters Medical Research, LLC

High Point, North Carolina, United States

PMG Research of Wilmington

Wilmington, North Carolina, United States

Lillestol Research LLC

Fargo, North Dakota, United States

CTI Clinical Research Center

Cincinnati, Ohio, United States

Sleep Management Institute (Intrepid)

Cincinnati, Ohio, United States

UC Health Sleep Medicine

Cincinnati, Ohio, United States

University Hospital of Cleveland Medical Center

Cleveland, Ohio, United States

Abington Neurological Associate

Abington, Pennsylvania, United States

Respiratory Specialists

Wyomissing, Pennsylvania, United States

Tribe Clinical Research LL

Greenville, South Carolina, United States

OnSite Clinical Solutions LLC/Carolina Cardiology Associates P.A

Rock Hill, South Carolina, United States

Chattanooga Research & Medicine, PLLC

Chattanooga, Tennessee, United States

FutureSearch Trials of Neurology

Austin, Texas, United States

FutureSearch Trials of Dallas, LP

Dallas, Texas, United States

The Heights Hospital (HD Heights)

Houston, Texas, United States

Weill Cornell Medical College

Houston, Texas, United States

Lone Star Lung and Sleep Clinic

Houston, Texas, United States

Huntsville Research Institute LLC

Huntsville, Texas, United States

Epic Medical Research

Red Oak, Texas, United States

Element Research Group

San Antonio, Texas, United States

South Ogden Family Medicine / CCT Research

South Ogden, Utah, United States

Canadian Sleep Consultants

Calgary, Alberta, Canada

Medical Arts Health Research

Kelowna, British Columbia, Canada

AMNDX

Markham, Ontario, Canada

West Ottawa Sleep Centre

Ottawa, Ontario, Canada

Canadian Phase Onward Inc.

Toronto, Ontario, Canada

Toronto Sleep Institute

Toronto, Ontario, Canada

Sleep and Alertness Center

Toronto, Ontario, Canada

McGill University Health Centre

Montreal, Quebec, Canada