Continuation Protocol for Obstructive Sleep Apnea (OSA)
- 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
- Completion of APC-APN-304 without permanent discontinuation of IMP.
- Completion of APC-APN-305 without permanent discontinuation of IMP.
- 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
Group Intervention Description AD109 Aroxybutynin and Atomoxetine Open Label AD109
- Primary Outcome Measures
Name Time Method 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 Abnormalities through 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
Name Time Method
Related Research Topics
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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