Hypertension, Obstructive Sleep Apnea
Conditions
Brief summary
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
Detailed description
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.
Interventions
DRUGAD113
Two oral capsules administered before bed
DRUGAtomoxetine
Two oral capsules administered before bed
Sponsors
Apnimed
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Between 25 to 65 years of age, inclusive, at the Screening Visit. * AHI 10 to 50 (hypopneas defined by 4% oxygen desaturation) * History of hypertension or blood pressure at Visit 1 ≥130/80 mmHg
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in hypoxic burden (HB, total area under the respiratory event-related desaturation curve) | 10 days of treatment per crossover arm | Change in HB for AD113 vs. atomoxetine measured by polysomnography atomoxetine |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Apnea-Hypopnea Index (AHI, average number of events for every hour of sleep) | 10 days of treatment per crossover arm | Change in AHI for AD113 vs. atomoxetine measured by polysomnography |
Countries
United States
Outcome results
None listed