Parallel Arm Trial of AD109 and AD504 In Patients With OSA
- Conditions
- OSA - Obstructive Sleep Apnea
- Interventions
- Registration Number
- NCT05071612
- Lead Sponsor
- Apnimed
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 294
- Between 18 to 65 years of age for men and 18-75 for women, inclusive, at the Screening Visit.
- Mean AHI 10 to 45 events/h, inclusive
- PGI-S: >1
- Current clinically significant sleep disorder other than OSA
- Clinically significant craniofacial malformation.
- Clinically significant cardiac disease (e.g. rhythm disturbances, coronary artery disease or heart failure or hypertension requiring more than 2 medications for control).
- Participants with a history of using devices for OSA treatment, including CPAP, oral or nasal devices, or positional devices, may enroll as long as the devices have not been used for at least 2 weeks prior to first PSG and are not used during participation in the study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description AD109 Dose 2 AD109 - AD109 Dose 1 AD109 - Atomoxetine 1 Atomoxetine Hydrochloride - Atomoxetine 2 Atomoxetine Hydrochloride - Placebo 2 Placebo - AD504 Dose 1 AD504 - Placebo 1 Placebo - AD504 Dose 2 AD504 -
- Primary Outcome Measures
Name Time Method Change in AHI, combined AD109 dose arms vs. combined placebo arms 28 Days Change in AHI (AHI, average number of events for every hour of sleep) measured by polysomnography
- Secondary Outcome Measures
Name Time Method Change in AHI, combined AD504 dose arms vs. combined placebo arms 28 Days Change in AHI (AHI, average number of events for every hour of sleep) measured by polysomnography
Change in AHI, combined atomoxetine dose arms vs. combined placebo arms 28 Days Change in AHI (AHI, average number of events for every hour of sleep) measured by polysomnography
Trial Locations
- Locations (25)
Velocity Clinical Research
🇺🇸Greenville, South Carolina, United States
The Center for Sleep & Wake Disorders
🇺🇸Chevy Chase, Maryland, United States
NeuroTrials Research, Inc.
🇺🇸Atlanta, Georgia, United States
Minnesota Lung Center / Minnesota Sleep Institute
🇺🇸Woodbury, Minnesota, United States
Bogan Sleep Consultants LLC
🇺🇸Columbia, South Carolina, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Clayton Sleep Institute
🇺🇸Maplewood, Missouri, United States
Coastal Carolina Health Care, P.A.
🇺🇸New Bern, North Carolina, United States
Delta Waves
🇺🇸Colorado Springs, Colorado, United States
Research Centers of America -- Hollywood
🇺🇸Hollywood, Florida, United States
Pacific Research Network
🇺🇸San Diego, California, United States
Sleep Medicine Specialists of South Florida
🇺🇸Miami, Florida, United States
Teradan Clinical Trials
🇺🇸Brandon, Florida, United States
Chicago Research Center
🇺🇸Chicago, Illinois, United States
Clinilabs
🇺🇸New York, New York, United States
Sleep and Attention Disorders Institute
🇺🇸Sterling Heights, Michigan, United States
Intrepid Research
🇺🇸Cincinnati, Ohio, United States
FutureSearch Trials of Neurology
🇺🇸Austin, Texas, United States
Neurocare
🇺🇸Newton, Massachusetts, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
Brian Abaluck, LLC
🇺🇸Malvern, Pennsylvania, United States
Santa Monica Clinical Trials
🇺🇸Los Angeles, California, United States
SDS Clinical Trials, Inc.
🇺🇸Santa Ana, California, United States
St. Luke's Hospital Sleep Medicine
🇺🇸Chesterfield, Missouri, United States
Sleep Disorders Centers of the Mid-Atlantic (SDCMA)
🇺🇸Glen Burnie, Maryland, United States