MedPath

Continuation Protocol for Obstructive Sleep Apnea (OSA)

Phase 3
Conditions
OSA
Interventions
Registration Number
NCT06566820
Lead 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
ENROLLING_BY_INVITATION
Sex
All
Target Recruitment
1280
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
AD109Aroxybutynin and AtomoxetineOpen Label AD109
Primary Outcome Measures
NameTimeMethod
Number of Participants With Adverse Events (AES) and Serious Adverse Events (SAEs)through study completion, an average of 1 year

An AE is any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of a study treatment, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study treatment. An SAE was an AE during any study phase that fulfills one or more of the following criteria: results in death, life threatening (The term 'life-threatening' in the definition of 'serious' refers to an event in which the participant was at risk of death at the time of the event. It does not refer to an event, which hypothetically might have caused death, if it were more severe), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity.

Number of Participants With Vital Signs Abnormalitiesthrough study completion, an average of 1 year

Vital signs that are planned to be assessed include parameters such as weight,heart rate and systolic and diastolic blood pressure.

Number of Participants With Concomitant Therapy (Medication or Devices)through study completion, an average of 1 year

Concomitant therapy with devices (i.e., CPAP) and concomitant medications are other prescription medications, over-the-counter (OTC) drugs or dietary supplements that a study participant takes in addition to the drug under investigation.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (98)

Sleep Disorders Center of America

🇺🇸

Birmingham, Alabama, United States

The University of Alabama/Institute for Rural Health Research

🇺🇸

Tuscaloosa, Alabama, United States

Chandler Clinical Trials

🇺🇸

Chandler, Arizona, United States

Desert Clinical Reserach, LLC/CCT Research

🇺🇸

Mesa, Arizona, United States

Foothills Research Center/CCT Research

🇺🇸

Phoenix, Arizona, United States

Fiel Family and Sports Medicine/CCT Research

🇺🇸

Tempe, Arizona, United States

Noble Clinical Research

🇺🇸

Tucson, Arizona, United States

Preferred Research Partners, Inc.

🇺🇸

Little Rock, Arkansas, United States

Orange County Research Institute

🇺🇸

Anaheim, California, United States

Core Healthcare Group

🇺🇸

Cerritos, California, United States

Scroll for more (88 remaining)
Sleep Disorders Center of America
🇺🇸Birmingham, Alabama, United States

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.