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, 2022

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 controlled with 1 – 2 medications, 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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