Trial of AD113 and Atomoxetine in OSA Patients With Hypertension
Overview
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
Full Title of Study: “Randomized Double-Blind 2-Period Multiple Dose Crossover Study to Evaluate the Efficacy and Safety of AD113 vs Atomoxetine in OSA Patients With Hypertension”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Crossover Assignment
- Primary Purpose: Treatment
- Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
- Study Primary Completion Date: January 31, 2023
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
- Drug: AD113
- Two oral capsules administered before bed
- Drug: Atomoxetine
- Two oral capsules administered before bed
Arms, Groups and Cohorts
- Experimental: AD113
- Two oral capsules administered before bed
- Experimental: Atomoxetine
- Two oral capsules administered before bed
Clinical Trial Outcome Measures
Primary Measures
- Change in hypoxic burden (HB, total area under the respiratory event-related desaturation curve)
- Time Frame: 10 days of treatment per crossover arm
- Change in HB for AD113 vs. atomoxetine measured by polysomnography atomoxetine
Secondary Measures
- Change in Apnea-Hypopnea Index (AHI, average number of events for every hour of sleep)
- Time Frame: 10 days of treatment per crossover arm
- Change in AHI for AD113 vs. atomoxetine measured by polysomnography
Participating in This Clinical Trial
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.
Gender Eligibility: All
Minimum Age: 25 Years
Maximum Age: 65 Years
Are Healthy Volunteers Accepted: No
Investigator Details
- Lead Sponsor
- Apnimed
- Provider of Information About this Clinical Study
- Sponsor
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