Trial of AD113 and Atomoxetine in OSA Patients With Hypertension

Apnimed

Status and phase

Completed

Phase 2

Conditions

Hypertension

Obstructive Sleep Apnea

Treatments

Drug: AD113

Drug: Atomoxetine

Study type

Interventional

Funder types

Industry

Identifiers

NCT04905979

APX-002

Details and patient eligibility

About

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 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.

Enrollment

21 patients

Sex

All

Ages

25 to 65 years old

Volunteers

No Healthy Volunteers

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.