NCT03845023

Trial of AD036 in Obstructive Sleep Apnea

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Apnimed · Industry
• Sex: All
• Age: 25 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Obstructive Sleep Apnea

Interventions

Type	Name	Description
DRUG	AD036 Dose 1	AD036 Dose 1 oral capsule administered before sleep
DRUG	AD036 Dose 2	AD036 Dose 2 oral capsule administered before sleep
DRUG	AD036 Dose 3	AD036 Dose 3 oral capsule administered before sleep
DRUG	Placebo	Placebo oral capsule administered before sleep

Timeline

• Start date: 2019-03-07
• Primary completion: 2019-10-23
• Completion: 2019-10-23
• First posted: 2019-02-19
• Last updated: 2023-01-17
• Results posted: 2023-01-17

Locations

12 sites across 1 country: United States

Regulatory

• FDA-regulated drug study