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Measuring Atomoxetine and Aroxybutynin In Patients With OSA — MARIPOSA  

Obstructive Sleep Apnea (OSA) Clinical Trial

Official title:
Phase 2 Randomized Double-Blind Placebo-Controlled Parallel-Arm Dose Finding Study to Compare Fixed Dose Combinations of Atomoxetine/Aroxybutynin (AD109) to Atomoxetine Alone or Placebo in Obstructive Sleep Apnea

Clinical Trial Summary

MARIPOSA is a randomized, double blind, placebo-controlled, parallel-arm 1-month study of AD109 in participants with OSA. Enrolled participants will be randomized to one of 5 parallel treatment arms.

Clinical Trial Description

MARIPOSA is a randomized, double blind, placebo-controlled, parallel-arm 1-month study in participants with OSA. A screening visit and polysomnograms (PSGs) will be conducted to establish that each participant meets study enrollment criteria. The screening PSGs will serve as the baseline for the PSGs conducted during the 3rd and 4th weeks of drug treatment. Enrolled participants will be randomized to one of 5 parallel treatment arms. The first week of dosing will be with a lower dose run-in of AD109 (or corresponding single-drug component or placebo), followed by the full dose taken in weeks 2-4. One combination tablet is taken each night immediately before lights out. A total of approximately 260 participants will be enrolled. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04939168
Study type Interventional
Source Apnimed
Contact
Status Not yet recruiting
Phase Phase 2
Start date September 30, 2021
Completion date April 1, 2022
View Details
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