Trial of AD113 and Atomoxetine in OSA Patients With Hypertension

Phase 2

Completed

• Conditions: Hypertension; Obstructive Sleep Apnea
• Interventions: Drug: AD113; Drug: Atomoxetine

• Registration Number: NCT04905979
• Lead Sponsor: Apnimed

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.

Study Timeline

• Study First Submitted: 2021-05-20
• Study First Submitted QC: 2021-05-24
• Study First Posted: 2021-05-28
• Study Start: 2021-07-31
• Primary Completion: 2023-01-31
• Status Verified: 2023-03
• Study Completion: 2023-05-31
• Last Update Submitted: 2023-08-17
• Last Update Posted: 2023-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AD113	AD113	Two oral capsules administered before bed
Atomoxetine	Atomoxetine	Two oral capsules administered before bed

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

PCCAB; 🇺🇸 Towson, Maryland, United States

Bogan Sleep Consultants; 🇺🇸 Columbia, South Carolina, United States

Intrepid Research; 🇺🇸 Cincinnati, Ohio, United States