Trial of AD113 and Atomoxetine in OSA Patients With Hypertension

• Status: Recruiting
• Trial end date: 2022-03-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Apnimed
• Treatments: Atomoxetine Hydrochloride

Criteria

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.