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
Trial Locations
- Locations (98)
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
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
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
Exalt Clinical Research, Inc.
🇺🇸Chula Vista, California, United States
Collaborative Neuroscience Research, LLC
🇺🇸Los Alamitos, California, United States
Santa Monica Clinical Trials
🇺🇸Los Angeles, California, United States
Empire Clinical Research
🇺🇸Pomona, California, United States
Probe Clinical Research Corporation
🇺🇸Riverside, California, United States
Pacific Research Network
🇺🇸San Diego, California, United States
TriValley Sleep Center
🇺🇸San Ramon, California, United States
SDS Clinical Trials, Inc.
🇺🇸Santa Ana, California, United States
Providere Research Inc.
🇺🇸West Covina, California, United States
Mountain View Clinical Research, Inc.
🇺🇸Denver, Colorado, United States
Meris Clinical Research
🇺🇸Brandon, Florida, United States
Teradan Clinical Trials
🇺🇸Brandon, Florida, United States
St. Francis Medical Institute
🇺🇸Clearwater, Florida, United States
Nouvelle Clinical Research
🇺🇸Cutler Bay, Florida, United States
Arrow Clinical Trials
🇺🇸Daytona Beach, Florida, United States
Canvas Clinical Research
🇺🇸Lake Worth, Florida, United States
Florida Lung & Sleep Associates
🇺🇸Lehigh Acres, Florida, United States
Ivetmar Medical Group, LLC
🇺🇸Miami, Florida, United States
Advanced Medical Research Institute
🇺🇸Miami, Florida, United States
PharmaDev Clinical Research Institute, LLC
🇺🇸Miami, Florida, United States
Flourish Research
🇺🇸Miami, Florida, United States
Renstar Medical Research
🇺🇸Ocala, Florida, United States
Clinical Neuroscience Solutions, Inc.
🇺🇸Memphis, Tennessee, United States
JSV Clinical Research Study Inc.
🇺🇸Tampa, Florida, United States
Palm Beach Research Center
🇺🇸West Palm Beach, Florida, United States
Central Florida Pediatric Sleep Disorders d/b/a Florida Pediatric Institute, LLC
🇺🇸Winter Park, Florida, United States
Clinical Site Partners, LLC dba Flourish Research
🇺🇸Winter Park, Florida, United States
Neurotrials Research Inc
🇺🇸Atlanta, Georgia, United States
Atlanta Center for Medical Research
🇺🇸Atlanta, Georgia, United States
CenExel iResearch, LLC
🇺🇸Decatur, Georgia, United States
Georgia Neurology and Sleep Medicine Associates
🇺🇸Suwanee, Georgia, United States
Medster Research
🇺🇸Valdosta, Georgia, United States
St. Luke's Idaho Pulmonary Associates - Meridian Clinic
🇺🇸Meridian, Idaho, United States
Chicago Research Center, Inc.
🇺🇸Chicago, Illinois, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Advanced ENT and Allergy
🇺🇸Louisville, Kentucky, United States
Centennial Medical Group Research Department
🇺🇸Columbia, Maryland, United States
Sleep Disorders Centers of the Mid-Atlantic
🇺🇸Glen Burnie, Maryland, United States
Velocity Clinical Research
🇺🇸Rockville, Maryland, United States
Neurocare, Inc.
🇺🇸Newton, Massachusetts, United States
Infinity Medical Research
🇺🇸North Dartmouth, Massachusetts, United States
Baystate Clinical Trials Unit
🇺🇸Springfield, Massachusetts, United States
University of Michigan Clinical Research Unit
🇺🇸Ann Arbor, Michigan, United States
Revive Research Institute, Inc.
🇺🇸Lathrup Village, Michigan, United States
Henry Ford Medical Center - Columbus
🇺🇸Novi, Michigan, United States
Clinical Neurophysiology Services PC
🇺🇸Sterling Heights, Michigan, United States
Sleep Medicine and Research Center, St. Luke's Hospital
🇺🇸Chesterfield, Missouri, United States
Healthcare Research Network
🇺🇸Hazelwood, Missouri, United States
Clayton Sleep Institute, LLC
🇺🇸St. Louis, Missouri, United States
Henderson Clinical Trials
🇺🇸Henderson, Nevada, United States
Las Vegas Clinical Trials, LLC
🇺🇸North Las Vegas, Nevada, United States
Clinilabs Drug Development Corporation
🇺🇸Eatontown, New Jersey, United States
Sleep Dynamics
🇺🇸Neptune, New Jersey, United States
Maimonides Sleep Arts & Sciences
🇺🇸Albuquerque, New Mexico, United States
Northwell Health
🇺🇸New Hyde Park, New York, United States
Research Carolina Elite
🇺🇸Denver, North Carolina, United States
Clinical Research of Gastonia
🇺🇸Gastonia, North Carolina, United States
Peters Medical Research LLC
🇺🇸High Point, North Carolina, United States
Advanced Respiratory and Sleep Medicine
🇺🇸Huntersville, North Carolina, United States
Coastal Carolina Health Care, P.A. Pulmonary and Sleep Medicine
🇺🇸New Bern, North Carolina, United States
Accellacare
🇺🇸Wilmington, North Carolina, United States
Lillestol Research
🇺🇸Fargo, North Dakota, United States
NeuroScience Research Center, LLC
🇺🇸Canton, Ohio, United States
CTI Clinical Research Center
🇺🇸Cincinnati, Ohio, United States
Intrepid Research, LLC
🇺🇸Cincinnati, Ohio, United States
Northwest Research Center
🇺🇸Portland, Oregon, United States
Abington Neurological Associates
🇺🇸Abington, Pennsylvania, United States
Respiratory Specialists
🇺🇸Wyomissing, Pennsylvania, United States
Lowcountry Lung and Critical Care, PA
🇺🇸Charleston, South Carolina, United States
Tribe Clinical Research, LLC
🇺🇸Greenville, South Carolina, United States
Velocity Clinical Research, Greenville
🇺🇸Greenville, South Carolina, United States
OnSite Clinical Solutions, LLC
🇺🇸Rock Hill, South Carolina, United States
Chattanooga Research & Medicine
🇺🇸Chattanooga, Tennessee, United States
FutureSearch Trials of Neurology
🇺🇸Austin, Texas, United States
FutureSearch Trials of Dallas
🇺🇸Dallas, Texas, United States
Memorial Hermann Village
🇺🇸Houston, Texas, United States
Houston Clinical Research Associates
🇺🇸Houston, Texas, United States
Huntsville Research Institute
🇺🇸Huntsville, Texas, United States
Sleep Therapy and Research Center
🇺🇸San Antonio, Texas, United States
Element Research Group
🇺🇸San Antonio, Texas, United States
South Ogden Family Medicine/CCT Research
🇺🇸South Ogden, Utah, United States
Sleep Disorder Center of the Mid-Atlantic
🇺🇸Vienna, Virginia, United States
Medical Arts Health Research Group
🇨🇦Kelowna, British Columbia, Canada
AMNDX Inc
🇨🇦Markham, Ontario, Canada
West Ottawa Sleep Centre
🇨🇦Ottawa, Ontario, Canada
Canadian Phase Onward Inc.
🇨🇦Toronto, Ontario, Canada
Jodha Tishon, Inc.
🇨🇦Toronto, Ontario, Canada
McGill University Health Centre
🇨🇦Montreal, Quebec, Canada