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NCT06566820 | RECRUITING | OSA

Continuation Protocol for Obstructive Sleep Apnea (OSA)
Sponsor:

Apnimed

Brief Summary:

The combination drug composed of aroxybutynin and atomoxetine, designated AD109, is being developed by Apnimed for the treatment of obstructive sleep apnea (OSA). The present study is a Phase 3 open label continuation protocol enrolling qualifying participants who completed one of the parent Phase 3 double-blind placebo-controlled studies, APC-APN-304 or APC-APN-305.

Condition or disease

OSA

Intervention/treatment

Aroxybutynin and Atomoxetine

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 1280 participants
Masking : NONE
Primary Purpose : OTHER
Official Title : A Phase 3 Open Label Continuation Protocol of a Fixed Dose Combination of Aroxybutynin and Atomoxetine (AD109) in Obstructive Sleep Apnea
Actual Study Start Date : 2024-07-03
Estimated Primary Completion Date : 2026-06-30
Estimated Study Completion Date : 2026-06-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • * Completion of APC-APN-304 without permanent discontinuation of IMP.
  • * Completion of APC-APN-305 without permanent discontinuation of IMP.
Exclusion Criteria
  • * Participants are excluded from the study if participation would be considered unsafe by the investigator based on the individual's current status.
  • * Participants are excluded from the study if participation would be considered unsafe by the investigator based on concomitant therapies.
Continuation Protocol for Obstructive Sleep Apnea (OSA)

Location Details

NCT06566820

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, California

Core Healthcare Group

Cerritos, California, United States, 90703

RECRUITING

United States, California

Exalt Clinical Research, Inc.

Chula Vista, California, United States, 91910

RECRUITING

United States, Florida

Canvas Clinical Research

Lake Worth, Florida, United States, 33467

RECRUITING

United States, Florida

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States, 32801

RECRUITING

United States, Georgia

Georgia Neurology and Sleep Medicine Associates

Suwanee, Georgia, United States, 30024

RECRUITING

United States, Maryland

Centennial Medical Group Research Department

Columbia, Maryland, United States, 21045

RECRUITING

United States, Pennsylvania

Abington Neurological Associates

Abington, Pennsylvania, United States, 19001

RECRUITING

United States, Texas

FutureSearch Trials of Dallas

dallas, Texas, United States, 75231

RECRUITING

United States, Texas

Huntsville Research Institute

Huntsville, Texas, United States, 77340