Status:
COMPLETED
Crossover Trial of AD036 in Obstructive Sleep Apnea
Lead Sponsor:
Apnimed
Conditions:
Obstructive Sleep Apnea
Eligibility:
All Genders
25-65 years
Phase:
PHASE2
Brief Summary
This is a randomized, 3-Period, Placebo-Controlled, Crossover, phase 2 clinical study to examine the efficacy and safety of AD036 versus placebo or atomoxetine in patients with obstructive sleep apnea...
Detailed Description
The study is designed to examine the efficacy and safety of AD036 to treat obstructive sleep apnea. The study is a three-period single-dose randomized crossover design in which patients will undergo o...
Eligibility Criteria
Inclusion
- Male or Female, between 25 to 65 years of age, inclusive, at the Screening Visit.
- AHI 10 to \<20, or AHI ≥20 if meets PSG criteria
Exclusion
- History of narcolepsy.
- 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.
Key Trial Info
Start Date :
July 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2020
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT04445688
Start Date
July 15 2020
End Date
December 1 2020
Last Update
September 14 2023
Active Locations (5)
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1
Preferred Research Partners, Inc.
Little Rock, Arkansas, United States, 72211
2
SDS Clinical Trials, Inc.
Santa Ana, California, United States, 92705
3
The Center for Sleep and Wake Disorders
Chevy Chase, Maryland, United States, 20815
4
Sleep Medicine & Research Center, St. Luke's Hospital
Chesterfield, Missouri, United States, 63017