Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
62 participants
INTERVENTIONAL
2020-07-15
2020-12-01
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
QUADRUPLE
Study Groups
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AD036
AD036 oral capsule administered before sleep
AD036
Oral administration before bed
Atomoxetine
Atomoxetine oral capsule administered before sleep
Atomoxetine
Oral administration before bed
Placebo
Placebo oral capsule administered before sleep
Placebo
Oral administration before bed
Interventions
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AD036
Oral administration before bed
Atomoxetine
Oral administration before bed
Placebo
Oral administration before bed
Eligibility Criteria
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Inclusion Criteria
* AHI 10 to \<20, or AHI ≥20 if meets PSG criteria
Exclusion Criteria
* Clinically significant craniofacial malformation.
* Clinically significant cardiac disease (e.g., rhythm disturbances, coronary artery disease or cardiac failure) or hypertension requiring more than 2 medications for control. A medication for these purposes is defined by dosage form, such that a combination antihypertensive medication is considered 1 medication
* CPAP should not be used for at least 2 weeks prior to first study PSG
* History of using oral or nasal devices for the treatment of OSA may enroll as long as the devices are not used during participation in the study.
25 Years
65 Years
ALL
No
Sponsors
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Apnimed
INDUSTRY
Responsible Party
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Locations
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Preferred Research Partners, Inc.
Little Rock, Arkansas, United States
SDS Clinical Trials, Inc.
Santa Ana, California, United States
The Center for Sleep and Wake Disorders
Chevy Chase, Maryland, United States
Sleep Medicine & Research Center, St. Luke's Hospital
Chesterfield, Missouri, United States
CTI Clinical Research Center
Cincinnati, Ohio, United States
Countries
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References
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Schweitzer PK, Maynard JP, Wylie PE, Emsellem HA, Sands SA. Efficacy of atomoxetine plus oxybutynin in the treatment of obstructive sleep apnea with moderate pharyngeal collapsibility. Sleep Breath. 2023 May;27(2):495-503. doi: 10.1007/s11325-022-02634-x. Epub 2022 May 13.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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APN-006
Identifier Type: -
Identifier Source: org_study_id
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