Trial of AD113 and Atomoxetine in OSA Patients With Hypertension

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Double-Blind 2-Period Multiple Dose Crossover Study to Evaluate the Efficacy and Safety of AD113 vs Atomoxetine in OSA Patients With Hypertension

Conditions
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Obstructive Sleep Apnea, Hypertension

Intervention / Treatment
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* Drug: AD113
* Drug: Atomoxetine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AD113<br>Two oral capsules administered before bed | Drug: AD113<br>* Two oral capsules administered before bed<br>|
| Experimental: Atomoxetine<br>Two oral capsules administered before bed | Drug: Atomoxetine<br>* Two oral capsules administered before bed<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 10 days of treatment per crossover arm | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 10 days of treatment per crossover arm |