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)
Status: Completed
Location: See all (73) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• ≥18 years of age at the time of informed consent.
• PSG criteria: AHI of ≥10 and ≤45; ≤ 25% central or mixed apneas; and PLM arousal index ≤15
• PROMIS-Fatigue: raw score ≥17
• PAP intolerance or current PAP refusal.
• BMI between 18.5 and 40 kg/m2 for men, or 42 kg/m2 for women, inclusive.
Locations
United States
Alabama
Alabama Neurology & Sleep Medicine
Tuscaloosa
Arkansas
Preferred Research Partners, Inc.
Little Rock
Arizona
Desert Clinical Research - CCT Research
Mesa
Foothills Research Center - CCT Research
Phoenix
Fiel Family Sports Medicine - PC CCT Research
Tempe
Noble Clinical Research
Tucson
California
Orange County Research Institute
Anaheim
North County Neurology Associates
Carlsbad
Core Healthcare Group
Cerritos
Exalt Clinical Research
Chula Vista
Catalina Research Institute
Montclair
Probe Clinical Research Corporation
Riverside
Pacific Research Network
San Diego
Sleep Medicine Specialists of California
San Ramon
SDS Clinical Trials Inc.
Santa Ana
Provideré Research Inc.
West Covina
Florida
Meris Clinical Research
Brandon
Nouvelle Clinical Research
Cutler Bay
Accel Research Sites
Deland
Research Centers of America, LLC
Hollywood
Canvas Clinical Research
Lake Worth
Florida Lung and Sleep Associates
Lehigh Acres
Advanced Medical Research Institute
Miami
Clinical Site Partners
Miami
Clinical Neuroscience Solutions, Inc - Orlando
Orlando
JSV Clinical Research Study Inc
Tampa
Florida Pediatric Research Institute
Winter Park
Georgia
Atlanta Center for Medical Research, LLC
Atlanta
NeuroTrials Research
Atlanta
Georgia Neurology and Sleep Medicine Assoc
Suwanee
Javarra Inc-Privia Medical Group
Thomasville
Idaho
St. Lukes Clinic - Idaho Pulmonary Associates
Meridian
Illinois
Chicago Research Center Inc
Chicago
OSF HealthCare Saint Francis Medical Center
Peoria
Kansas
The University of Kansas Medical Center
Kansas City
Kentucky
Advanced ENT and Allergy
Louisville
Massachusetts
Infinity Medical Research
North Dartmouth
Maryland
Centennial Medical Group
Elkridge
Michigan
University of Michigan
Ann Arbor
Revive Research Institute
Lathrup Village
North Carolina
Javara Inc - Tryon Medical Partners PLCC
Charlotte
Research Carolina Elite
Denver
Peters Medical Research, LLC
High Point
PMG Research of Wilmington
Wilmington
North Dakota
Lillestol Research LLC
Fargo
New Jersey
Neurology Specialists of Monmouth County
West Long Branch
Nevada
Las Vegas Clinical Trials
North Las Vegas
Ohio
CTI Clinical Research Center
Cincinnati
Sleep Management Institute (Intrepid)
Cincinnati
UC Health Sleep Medicine
Cincinnati
University Hospital of Cleveland Medical Center
Cleveland
Pennsylvania
Abington Neurological Associate
Abington
Respiratory Specialists
Wyomissing
South Carolina
Tribe Clinical Research LL
Greenville
OnSite Clinical Solutions LLC/Carolina Cardiology Associates P.A
Rock Hill
Tennessee
Chattanooga Research & Medicine, PLLC
Chattanooga
Texas
FutureSearch Trials of Neurology
Austin
FutureSearch Trials of Dallas, LP
Dallas
Lone Star Lung and Sleep Clinic
Houston
The Heights Hospital (HD Heights)
Houston
Weill Cornell Medical College
Houston
Huntsville Research Institute LLC
Huntsville
Epic Medical Research
Red Oak
Element Research Group
San Antonio
Utah
South Ogden Family Medicine / CCT Research
South Ogden
Other Locations
Canada
Canadian Sleep Consultants
Calgary
Medical Arts Health Research
Kelowna
AMNDX
Markham
McGill University Health Centre
Montreal
West Ottawa Sleep Centre
Ottawa
Canadian Phase Onward Inc.
Toronto
Sleep and Alertness Center
Toronto
Toronto Sleep Institute
Toronto
Time Frame
Start Date: 2023-09-16
Completion Date: 2025-03-14
Participants
Target number of participants: 646
Treatments
Experimental: AD109
AD109
Placebo_comparator: Placebo
Placebo
Related Therapeutic Areas
Sponsors
Leads: Apnimed