This is a Phase 3 Randomized Double-Blind Placebo-Controlled 6-month Parallel-Arm Study to Compare a Fixed Dose Combination of AD109 to Placebo in Obstructive Sleep Apnea.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
646
Aroxybutynin 2.5 mg/atomoxetine 75 mg tablet, administered orally once daily at bedtime (Weeks 2-26). Week 1 run-in: aroxybutynin 2.5 mg/atomoxetine 37.5 mg tablet.
Matching placebo tablet administered orally once daily at bedtime for 26 weeks, with run-in and target dose matched to active arm packaging
Change From Baseline in Apnea-Hypopnea Index (AHI)
AHI, Apnea-Hypopnea Index, is the number of apneas or hypopneas recorded via polysomnography during the study per hour of sleep. Apnea is defined as a cessation of airflow lasting at least 10 seconds, hypopnea as a decrease in airflow by at least 30% from baseline for at least 10 seconds occurring with a drop in oxygen saturation (SpO2) by at least 4%.
Time frame: 6 months
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