This is a randomized, double blind, 2-period, non placebo-controlled crossover study in patients with moderate to severe OSA and controlled hypertension, comparing atomoxetine with AD113
The study is designed to examine the efficacy and safety of AD113 to treat obstructive sleep apnea with hypertension. The study is a two-period multi-dose randomized crossover design in which patients will undergo overnight polysomnographic (PSG) testing with dosing of one of the following 2 treatments: AD113 for 10 days or Atomoxetine for 10 days. Participants will return 1 week after their final crossover PSG for an end of study (EOS) Visit.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
21
Two oral capsules administered before bed
Two oral capsules administered before bed
PCCAB
Towson, Maryland, United States
Intrepid Research
Cincinnati, Ohio, United States
Bogan Sleep Consultants
Columbia, South Carolina, United States
Change in hypoxic burden (HB, total area under the respiratory event-related desaturation curve)
Change in HB for AD113 vs. atomoxetine measured by polysomnography atomoxetine
Time frame: 10 days of treatment per crossover arm
Change in Apnea-Hypopnea Index (AHI, average number of events for every hour of sleep)
Change in AHI for AD113 vs. atomoxetine measured by polysomnography
Time frame: 10 days of treatment per crossover arm
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