Trial of AD036 in Obstructive Sleep Apnea

Obstructive Sleep Apnea Clinical Trial

Official title: Phase 2, Placebo-Controlled, Parallel Group Dose-Finding Study to Evaluate the Efficacy and Safety of Three Dose Levels of AD036 in Adults With Obstructive Sleep Apnea

Status Completed

Clinical Trial Summary

This is a randomized, double blind, placebo-controlled, repeat-dose, parallel arm, outpatient and inpatient phase 2 clinical study to examine the efficacy and safety of three dose levels of AD036 versus placebo in patients with obstructive sleep apnea.

Clinical Trial Description

This was a randomized, double-blind, placebo-controlled, repeat-dose, parallel arm, outpatient and inpatient, multicenter, dose-finding study of the combination of atomoxetine and oxybutynin in adults with OSA documented by polysomnography (PSG).

Approximately 140 subjects were to be randomized 1:1:1:1 to receive 1 of 3 different fixed-dose combinations of oxybutynin and atomoxetine or matching placebo.

For all subjects, the study consisted of:

• A screening and baseline period in which subjects' eligibility was determined

• An initial 2-night, at-home blinded baseline period in which all subjects received placebo

• A 3-night, run-in period in which subjects received:

• Low-dose combination for subjects randomized to one of the 3 study treatment arms

• Placebo for subjects randomized to the placebo treatment arm

• A 7-night treatment period in which subjects received the treatment to which they were randomized, i.e., 1 of the 3 different fixed-dose combinations of drugs, or placebo

• An end of study visit ;

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

• NCT number: NCT03845023
• Study type: Interventional
• Source: Apnimed
• Status: Completed
• Phase: Phase 2
• Start date: March 7, 2019
• Completion date: October 23, 2019