OSAPhase 3NCT06566820
Continuation Protocol for Obstructive Sleep Apnea (OSA)
A Phase 3 study testing Aroxybutynin and Atomoxetine in people with OSA, run by Apnimed at 99 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- OSA
- What is being tested?
- Aroxybutynin and Atomoxetine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,280 participants
- Where
- 99 sitesin 2 countries
- Study dates
- 3 Jul 2024to 30 Jun 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Completion of APC-APN-304 without permanent discontinuation of IMP.
- Completion of APC-APN-305 without permanent discontinuation of IMP.
Who cannot join
- 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.
Trial locations and contacts
99 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
99 sites in 2 countries
United States93 sites
Abington Neurological Associates
Abington, Pennsylvania, 19001
Maimonides Sleep Arts & Sciences
Albuquerque, New Mexico, 87107
Orange County Research Institute
Anaheim, California, 92801
University of Michigan Clinical Research Unit
Ann Arbor, Michigan, 48109
Neurotrials Research Inc
Atlanta, Georgia, 30328
Atlanta Center for Medical Research
Atlanta, Georgia, 30331
FutureSearch Trials of Neurology
Austin, Texas, 78731
Sleep Disorders Center of America
Birmingham, Alabama, 35213
Meris Clinical Research
Brandon, Florida, 33511
Teradan Clinical Trials
Brandon, Florida, 33511
NeuroScience Research Center, LLC
Canton, Ohio, 44718
Core Healthcare Group
Cerritos, California, 90703
Chandler Clinical Trials
Chandler, Arizona, 85224
Lowcountry Lung and Critical Care, PA
Charleston, South Carolina, 29406
Chattanooga Research & Medicine
Chattanooga, Tennessee, 37404
Sleep Medicine and Research Center, St. Luke's Hospital
Chesterfield, Missouri, 63017
Chicago Research Center, Inc.
Chicago, Illinois, 60634
Exalt Clinical Research, Inc.
Chula Vista, California, 91910
CTI Clinical Research Center
Cincinnati, Ohio, 45212
Intrepid Research, LLC
Cincinnati, Ohio, 45245
St. Francis Medical Institute
Clearwater, Florida, 33765
Centennial Medical Group Research Department
Columbia, Maryland, 21045
Nouvelle Clinical Research
Cutler Bay, Florida, 33189
FutureSearch Trials of Dallas
Dallas, Texas, 75231
Arrow Clinical Trials
Daytona Beach, Florida, 32117
CenExel iResearch, LLC
Decatur, Georgia, 30030
Mountain View Clinical Research, Inc.
Denver, Colorado, 80209
Research Carolina Elite
Denver, North Carolina, 28037
Clinilabs Drug Development Corporation
Eatontown, New Jersey, 07724
Lillestol Research
Fargo, North Dakota, 58104
Clinical Research of Gastonia
Gastonia, North Carolina, 28054
Sleep Disorders Centers of the Mid-Atlantic
Glen Burnie, Maryland, 21061
Tribe Clinical Research, LLC
Greenville, South Carolina, 29607
Velocity Clinical Research, Greenville
Greenville, South Carolina, 29615
Healthcare Research Network
Hazelwood, Missouri, 63042
Henderson Clinical Trials
Henderson, Nevada, 89052
Peters Medical Research LLC
High Point, North Carolina, 27260
Memorial Hermann Village
Houston, Texas, 77043
Houston Clinical Research Associates
Houston, Texas, 77070
Advanced Respiratory and Sleep Medicine
Huntersville, North Carolina, 28078
Huntsville Research Institute
Huntsville, Texas, 77340
University of Kansas Medical Center
Kansas City, Kansas, 66160
Canvas Clinical Research
Lake Worth, Florida, 33467
Revive Research Institute, Inc.
Lathrup Village, Michigan, 48076
Florida Lung & Sleep Associates
Lehigh Acres, Florida, 33971
Preferred Research Partners, Inc.
Little Rock, Arkansas, 72211
Collaborative Neuroscience Research, LLC
Los Alamitos, California, 90720
Santa Monica Clinical Trials
Los Angeles, California, 90025
Advanced ENT and Allergy
Louisville, Kentucky, 40220
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, 38119
St. Luke's Idaho Pulmonary Associates - Meridian Clinic
Meridian, Idaho, 83642
Desert Clinical Reserach, LLC/CCT Research
Mesa, Arizona, 85213
Ivetmar Medical Group, LLC
Miami, Florida, 33155
Advanced Medical Research Institute
Miami, Florida, 33174
PharmaDev Clinical Research Institute, LLC
Miami, Florida, 33176
Flourish Research
Miami, Florida, 33186
Sleep Dynamics
Neptune City, New Jersey, 07753
Coastal Carolina Health Care, P.A. Pulmonary and Sleep Medicine
New Bern, North Carolina, 28562
Northwell Health
New Hyde Park, New York, 11042
Neurocare, Inc.
Newton, Massachusetts, 02459
Infinity Medical Research
North Dartmouth, Massachusetts, 02747
Las Vegas Clinical Trials, LLC
North Las Vegas, Nevada, 89030
Henry Ford Medical Center - Columbus
Novi, Michigan, 48377
Renstar Medical Research
Ocala, Florida, 34470
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, 32801
Foothills Research Center/CCT Research
Phoenix, Arizona, 85044
Empire Clinical Research
Pomona, California, 91767
Northwest Research Center
Portland, Oregon, 97202
Probe Clinical Research Corporation
Riverside, California, 92501
OnSite Clinical Solutions, LLC
Rock Hill, South Carolina, 29732
Velocity Clinical Research
Rockville, Maryland, 20854
Sleep Therapy and Research Center
San Antonio, Texas, 78229
Element Research Group
San Antonio, Texas, 78258
Pacific Research Network
San Diego, California, 92103
TriValley Sleep Center
San Ramon, California, 94583
SDS Clinical Trials, Inc.
Santa Ana, California, 92705
South Ogden Family Medicine/CCT Research
South Ogden, Utah, 84405
Baystate Clinical Trials Unit
Springfield, Massachusetts, 01107
Clayton Sleep Institute, LLC
St Louis, Missouri, 63123
Clinical Neurophysiology Services PC
Sterling Heights, Michigan, 48314
Georgia Neurology and Sleep Medicine Associates
Suwanee, Georgia, 30024
JSV Clinical Research Study Inc.
Tampa, Florida, 33634
Fiel Family and Sports Medicine/CCT Research
Tempe, Arizona, 85283
Noble Clinical Research
Tucson, Arizona, 85704
The University of Alabama/Institute for Rural Health Research
Tuscaloosa, Alabama, 35401
Medster Research
Valdosta, Georgia, 31605
Sleep Disorder Center of the Mid-Atlantic
Vienna, Virginia, 22182
Providere Research Inc.
West Covina, California, 91790
Palm Beach Research Center
West Palm Beach, Florida, 33409
Accellacare
Wilmington, North Carolina, 28412
Central Florida Pediatric Sleep Disorders d/b/a Florida Pediatric Institute, LLC
Winter Park, Florida, 32789
Clinical Site Partners, LLC dba Flourish Research
Winter Park, Florida, 32789
Respiratory Specialists
Wyomissing, Pennsylvania, 19610
Canada6 sites
Medical Arts Health Research Group
Kelowna, British Columbia, VIY 4N7
AMNDX Inc
Markham, Ontario, L3R 1A3
McGill University Health Centre
Montreal, Quebec, H4A 3J1
West Ottawa Sleep Centre
Ottawa, Ontario, K2C 0P7
Canadian Phase Onward Inc.
Toronto, Ontario, M3J 0K2
Jodha Tishon, Inc.
Toronto, Ontario, M5S 3A3
About this study
Official title: A Phase 3 Open Label Continuation Protocol of a Fixed Dose Combination of Aroxybutynin and Atomoxetine (AD109) in Obstructive Sleep Apnea
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.
- Conditions
- OSA
- Being tested
- Aroxybutynin and Atomoxetine
- Keywords
- Obstructive Sleep Apnea
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aroxybutynin and AtomoxetineDrug
Also called AD109
Fixed Dose Combination
| Study group | Role | What they receive |
|---|---|---|
| AD109 | Experimental | Open Label AD109 Receives: Drug: Aroxybutynin and Atomoxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AES) and Serious Adverse Events (SAEs)
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.
Measured: through study completion, an average of 1 year
Number of Participants With Vital Signs Abnormalities
Vital signs that are planned to be assessed include parameters such as weight,heart rate and systolic and diastolic blood pressure.
Measured: through study completion, an average of 1 year
Number of Participants With Concomitant Therapy (Medication or Devices)
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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study start3 Jul 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OSAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Apnimed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ron Farkas, MD, Study director, Apnimed
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06566820
- Sponsor's protocol ID
- APC-APN-306
- Status last verified
- May 2025
- First submitted
- 3 Jul 2024
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3 Open Label Continuation Protocol of a Fixed Dose Combination of Aroxybutynin and Atomoxetine (AD109) in Obstructive Sleep Apnea
- ClinicalTrials.gov ID
- NCT06566820
- Acronym / sponsor ID
- APC-APN-306
- Conditions
- OSA
- Keywords
- Obstructive Sleep Apnea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,280 participants (estimated)
- Lead sponsor
- ApnimedIndustry (pharma, biotech, devices)
- Study start
- 3 Jul 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 22 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AD109 | Experimental | Drug: Aroxybutynin and AtomoxetineOpen Label AD109 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Completion of APC-APN-304 without permanent discontinuation of IMP.
- Completion of APC-APN-305 without permanent discontinuation of IMP.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aroxybutynin and AtomoxetineAlso: AD109Fixed Dose Combination | Drug | AD109 |
Primary outcome
Number of Participants With Adverse Events (AES) and Serious Adverse Events (SAEs)
Time frame: 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
Time frame: 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)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ron Farkas, MD study director
Apnimed
99 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Aroxybutynin and Atomoxetine in people with OSA, run by Apnimed at 99 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 99 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AES) and Serious Adverse Events (SAEs) (time frame: through study completion, an average of 1 year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025.