This is a randomized, double blind, placebo-controlled, repeat-dose, parallel arm, outpatient and inpatient phase 2 clinical study to examine the efficacy and safety of three dose levels of AD036 versus placebo in patients with obstructive sleep apnea.
This was a randomized, double-blind, placebo-controlled, repeat-dose, parallel arm, outpatient and inpatient, multicenter, dose-finding study of the combination of atomoxetine and oxybutynin in adults with OSA documented by polysomnography (PSG). Approximately 140 subjects were to be randomized 1:1:1:1 to receive 1 of 3 different fixed-dose combinations of oxybutynin and atomoxetine or matching placebo. For all subjects, the study consisted of: * A screening and baseline period in which subjects' eligibility was determined * An initial 2-night, at-home blinded baseline period in which all subjects received placebo * A 3-night, run-in period in which subjects received: * Low-dose combination for subjects randomized to one of the 3 study treatment arms * Placebo for subjects randomized to the placebo treatment arm * A 7-night treatment period in which subjects received the treatment to which they were randomized, i.e., 1 of the 3 different fixed-dose combinations of drugs, or placebo * An end of study visit
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
140
AD036 Dose 1 oral capsule administered before sleep
AD036 Dose 2 oral capsule administered before sleep
AD036 Dose 3 oral capsule administered before sleep
Pulmonary Associates
Glendale, Arizona, United States
Preferred Research Partners, Inc.
Little Rock, Arkansas, United States
Stanford Sleep Medicine
Redwood City, California, United States
Apnea Hypopnea Index (AHI)
Number of participants with ≥50% reduction in apnea hypopnea index (AHI). AHI is the average number of apneas and hypopneas a person experiences each hour during sleep, to register as an event an apnea or hypopnea must last at least 10 seconds or longer. To measure this, doctors divide the total number of apneic and hypopneic events by the total number of hours the person was asleep.
Time frame: 10 days
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Placebo oral capsule administered before sleep
SDS Clinical Trials, Inc.
Santa Ana, California, United States
Santa Monica Clinical Trials
Santa Monica, California, United States
Northwestern University
Chicago, Illinois, United States
Norton Clinical Research Group
Louisville, Kentucky, 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
Clinilabs Drug Development Corporation
New York, New York, United States
...and 2 more locations