Parallel Arm Trial of AD109 and AD504 In Patients With OSA
NCT ID: NCT05071612
Last Updated: 2022-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
294 participants
INTERVENTIONAL
2021-11-29
2022-08-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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AD109 Dose 1
AD109
Oral administration at bedtime
AD109 Dose 2
AD109
Oral administration at bedtime
AD504 Dose 1
AD504
Oral administration at bedtime
AD504 Dose 2
AD504
Oral administration at bedtime
Atomoxetine 1
Atomoxetine Hydrochloride
Oral administration at bedtime
Atomoxetine 2
Atomoxetine Hydrochloride
Oral administration at bedtime
Placebo 1
Placebo
Oral administration at bedtime
Placebo 2
Placebo
Oral administration at bedtime
Interventions
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AD109
Oral administration at bedtime
AD504
Oral administration at bedtime
Atomoxetine Hydrochloride
Oral administration at bedtime
Placebo
Oral administration at bedtime
Eligibility Criteria
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Inclusion Criteria
* Mean AHI 10 to 45 events/h, inclusive
* PGI-S: \>1
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Apnimed
INDUSTRY
Responsible Party
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Locations
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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
Countries
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References
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Schweitzer PK, Taranto-Montemurro L, Ojile JM, Thein SG, Drake CL, Rosenberg R, Corser B, Abaluck B, Sangal RB, Maynard J. The Combination of Aroxybutynin and Atomoxetine in the Treatment of Obstructive Sleep Apnea (MARIPOSA): A Randomized Controlled Trial. Am J Respir Crit Care Med. 2023 Dec 15;208(12):1316-1327. doi: 10.1164/rccm.202306-1036OC.
Other Identifiers
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MARIPOSA
Identifier Type: -
Identifier Source: org_study_id