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Parallel Arm Trial of AD109 and AD504 In Patients With OSA
Sponsor: Apnimed
Summary
This is a phase 2 randomized double-blind placebo-controlled parallel-arm dose finding study to compare fixed dose combinations of AD109 and AD504 to atomoxetine or placebo in Obstructive Sleep Apnea.
Official title: Phase 2 Randomized Double-Blind Placebo-Controlled Parallel-Arm Dose Finding Study to Compare Fixed Dose Combinations of AD109 and AD504 to Atomoxetine or Placebo in Obstructive Sleep Apnea
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
294
Start Date
2021-11-29
Completion Date
2022-08-03
Last Updated
2026-08-12
Healthy Volunteers
No
Conditions
Interventions
AD109
Oral administration at bedtime
AD504
Oral administration at bedtime
Atomoxetine Hydrochloride
Oral administration at bedtime
Placebo
Oral administration at bedtime
Locations (25)
Santa Monica Clinical Trials
Los Angeles, California, United States
Pacific Research Network
San Diego, California, United States
SDS Clinical Trials, Inc.
Santa Ana, California, United States
Delta Waves
Colorado Springs, Colorado, United States
Teradan Clinical Trials
Brandon, Florida, United States
Research Centers of America -- Hollywood
Hollywood, Florida, United States
Sleep Medicine Specialists of South Florida
Miami, Florida, United States
NeuroTrials Research, Inc.
Atlanta, Georgia, United States
Chicago Research Center
Chicago, Illinois, United States
The Center for Sleep & Wake Disorders
Chevy Chase, Maryland, United States
Sleep Disorders Centers of the Mid-Atlantic (SDCMA)
Glen Burnie, Maryland, United States
Neurocare
Newton, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
Sleep and Attention Disorders Institute
Sterling Heights, Michigan, United States
Minnesota Lung Center / Minnesota Sleep Institute
Woodbury, Minnesota, United States
St. Luke's Hospital Sleep Medicine
Chesterfield, Missouri, United States
Clayton Sleep Institute
Maplewood, Missouri, United States
Clinilabs
New York, New York, United States
Coastal Carolina Health Care, P.A.
New Bern, North Carolina, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Intrepid Research
Cincinnati, Ohio, United States
Brian Abaluck, LLC
Malvern, Pennsylvania, United States
Bogan Sleep Consultants LLC
Columbia, South Carolina, United States
Velocity Clinical Research
Greenville, South Carolina, United States
FutureSearch Trials of Neurology
Austin, Texas, United States