About this trial
Last updated 2 years ago
Study ID
APC-004
Status
Completed
Type
Interventional
Phase
Phase 2
Placebo
No
Accepting
25 to 65 Years
All
Not accepting
Healthy Volunteers
Trial Timing
Ended 4 years ago
What is this trial about?
This is a randomized, 3-period, placebo-controlled, crossover, phase 2 clinical study to
examine the efficacy and safety of 2 doses of AD109 vs placebo in patients with mild
obstructive sleep apnea.
What are the participation requirements?
Inclusion Criteria
- AHI between 5 and 20 events/h
- PGI-S equal to or higher than 1, or one or more of the following symptoms:
- Snoring or nightime gasping/choking
- Daytime sleepiness, fatigue or decreased concentration
- Nonrefreshing sleep, sleep fragmentation (including from nocturia), or morning headache
- Irritability, decreased mood or libido
Exclusion Criteria
- History of narcolepsy.
- 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).
- CPAP should not be used for at least 2 weeks prior to the study
- 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.