Trial of AD113 and Atomoxetine in OSA Patients With Hypertension

Completed · Phase 2

Conditions studied: Obstructive Sleep Apnea, Hypertension

In brief

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

Key facts

Study ID

NCT04905979

Run by

Apnimed

People needed

21

Starts

2021-07-31

Expected to finish

2023-05-31

Last updated by the study team

2023-08-21

Who can join

Age: 25 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• PCCAB — Towson, Maryland, United States
• Intrepid Research — Cincinnati, Ohio, United States
• Bogan Sleep Consultants — Columbia, South Carolina, United States

Full record on ClinicalTrials.gov

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