Trial of AD113 and Atomoxetine in OSA Patients With Hypertension

NCT ID: NCT04905979

Last Updated: 2023-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-31
• Study Completion Date: 2023-05-31

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.

Conditions

Obstructive Sleep Apnea; Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

AD113

Two oral capsules administered before bed

Group Type: EXPERIMENTAL

AD113

Intervention Type: DRUG

Two oral capsules administered before bed

Atomoxetine

Two oral capsules administered before bed

Group Type: EXPERIMENTAL

Atomoxetine

Intervention Type: DRUG

Two oral capsules administered before bed

Interventions

AD113

Two oral capsules administered before bed

Intervention Type: DRUG

Atomoxetine

Two oral capsules administered before bed

Intervention Type: DRUG

Eligibility 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 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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Apnimed

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

PCCAB

Towson, Maryland, United States

Intrepid Research

Cincinnati, Ohio, United States

Bogan Sleep Consultants

Columbia, South Carolina, United States

Countries

United States

References

Schwartz AR, Herpel L, Bogan R, Corser B, Pho H, Taranto-Montemurro L. Atomoxetine and spironolactone combine to reduce obstructive sleep apnea severity and blood pressure in hypertensive patients. Sleep Breath. 2024 Dec;28(6):2571-2580. doi: 10.1007/s11325-024-03113-1. Epub 2024 Sep 21.

Reference Type: DERIVED

PMID: 39305436 (View on PubMed)

Other Identifiers

APX-002

Identifier Type: -

Identifier Source: org_study_id