Trial of AD113 and Atomoxetine in OSA Patients With Hypertension

Hypertension Clinical Trial

Official title:

Randomized Double-Blind 2-Period Multiple Dose Crossover Study to Evaluate the Efficacy and Safety of AD113 vs Atomoxetine in OSA Patients With Hypertension

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04905979
• Other study ID #: APX-002
• Status: Completed
• Phase: Phase 2
• Start date: July 31, 2021
• Est. completion date: May 31, 2023

Study information

• Verified date: March 2023
• Source: Apnimed
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Obstructive Sleep Apnea
• Sleep Apnea, Obstructive

Intervention

Drug:
• AD113
Two oral capsules administered before bed
• Atomoxetine
Two oral capsules administered before bed

Locations

Country	Name	City	State
United States	Intrepid Research	Cincinnati	Ohio
United States	Bogan Sleep Consultants	Columbia	South Carolina
United States	PCCAB	Towson	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Apnimed

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in hypoxic burden (HB, total area under the respiratory event-related desaturation curve)	Change in HB for AD113 vs. atomoxetine measured by polysomnography atomoxetine	10 days of treatment per crossover arm
Secondary	Change in Apnea-Hypopnea Index (AHI, average number of events for every hour of sleep)	Change in AHI for AD113 vs. atomoxetine measured by polysomnography	10 days of treatment per crossover arm