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Enrolling by invitationPhase 3

Continuation Protocol for Obstructive Sleep Apnea (OSA)

Key facts

Where
Abington, Albuquerque, Anaheim, Ann Arbor, Atlanta, Austin, Birmingham, Brandon, Canton, Cerritos, Chandler, Charleston, Chattanooga, Chesterfield, Chicago, Chula Vista, Cincinnati, Clearwater, Columbia, Cutler Bay, Dallas, Daytona Beach, Decatur, Denver, Eatontown, Fargo, Gastonia, Glen Burnie, Greenville, Hazelwood, Henderson, High Point, Houston, Huntersville, Huntsville, Kansas City, Lake Worth, Lathrup Village, Lehigh Acres, Little Rock, Los Alamitos, Los Angeles, Louisville, Memphis, Meridian, Mesa, Miami, Neptune City, New Bern, New Hyde Park, Newton, North Dartmouth, North Las Vegas, Novi, Ocala, Orlando, Phoenix, Pomona, Portland, Riverside, Rock Hill, Rockville, San Antonio, San Diego, San Ramon, Santa Ana, South Ogden, Springfield, St Louis, Sterling Heights, Suwanee, Tampa, Tempe, Tucson, Tuscaloosa, Valdosta, Vienna, West Covina, West Palm Beach, Wilmington, Winter Park, and Wyomissing, United StatesSee the 93 sites
Phase
Phase 3

Where in United States

  • Abington Neurological AssociatesAbington, United StatesNo longer taking part
  • Maimonides Sleep Arts & SciencesAlbuquerque, United StatesNo longer taking part
  • Orange County Research InstituteAnaheim, United StatesNo longer taking part
  • University of Michigan Clinical Research UnitAnn Arbor, United StatesNo longer taking part
  • Atlanta Center for Medical ResearchAtlanta, United StatesNo longer taking part
  • NeuroTrials Research IncAtlanta, United StatesNo longer taking part
  • FutureSearch Trials of NeurologyAustin, United StatesNo longer taking part
  • Sleep Disorders Center of AmericaBirmingham, United StatesNo longer taking part
  • Meris Clinical ResearchBrandon, United StatesNo longer taking part
  • Teradan Clinical TrialsBrandon, United StatesNo longer taking part
  • NeuroScience Research Center LLCCanton, United StatesNo longer taking part
  • Core Healthcare GroupCerritos, United StatesNo longer taking part
  • Chandler Clinical TrialsChandler, United StatesNo longer taking part
  • Lowcountry Lung and Critical Care, PACharleston, United StatesNo longer taking part
  • Chattanooga Research & MedicineChattanooga, United StatesNo longer taking part
  • Sleep Medicine and Research Center, St. Luke's HospitalChesterfield, United StatesNo longer taking part
  • Chicago Research Center Inc.Chicago, United StatesNo longer taking part
  • Exalt Clinical Research IncChula Vista, United StatesNo longer taking part
  • CTI Clinical Research CenterCincinnati, United StatesNo longer taking part
  • Intrepid Research, LLCCincinnati, United StatesNo longer taking part
  • St Francis Medical InstituteClearwater, United StatesNo longer taking part
  • Centennial Medical Group Research DepartmentColumbia, United StatesNo longer taking part
  • Nouvelle Clinical ResearchCutler Bay, United StatesNo longer taking part
  • FutureSearch Trials of DallasDallas, United StatesNo longer taking part
  • Arrow Clinical TrialsDaytona Beach, United StatesNo longer taking part
  • CenExel iResearch, LLCDecatur, United StatesNo longer taking part
  • Mountain View Clinical Research, IncDenver, United StatesNo longer taking part
  • Research Carolina EliteDenver, United StatesNo longer taking part
  • Clinilabs Drug Development CorporationEatontown, United StatesNo longer taking part
  • Lillestol ResearchFargo, United StatesNo longer taking part
  • Clinical Research of GastoniaGastonia, United StatesNo longer taking part
  • Sleep Disorders Centers of the Mid-AtlanticGlen Burnie, United StatesNo longer taking part
  • Tribe Clinical Research LLCGreenville, United StatesNo longer taking part
  • Velocity Clinical Research - GreenvilleGreenville, United StatesNo longer taking part
  • Healthcare Research NetworkHazelwood, United StatesNo longer taking part
  • Henderson Clinical TrialsHenderson, United StatesNo longer taking part
  • Peters Medical Research, LLCHigh Point, United StatesNo longer taking part
  • Houston Clinical Research AssociatesHouston, United StatesNo longer taking part
  • Memorial Hermann VillageHouston, United StatesNo longer taking part
  • Advanced Respiratory and Sleep MedicineHuntersville, United StatesNo longer taking part
  • Huntsville Research InstituteHuntsville, United StatesNo longer taking part
  • University of Kansas Medical CenterKansas City, United StatesNo longer taking part
  • Canvas Clinical ResearchLake Worth, United StatesNo longer taking part
  • Revive Research Institute, Inc.Lathrup Village, United StatesNo longer taking part
  • Florida Lung & Sleep AssociatesLehigh Acres, United StatesNo longer taking part
  • Preferred Research Partners, IncLittle Rock, United StatesNo longer taking part
  • Collaborative Neuroscience Research, LLCLos Alamitos, United StatesNo longer taking part
  • Santa Monica Clinical TrialsLos Angeles, United StatesNo longer taking part
  • Advanced ENT and AllergyLouisville, United StatesNo longer taking part
  • Clinical Neuroscience Solutions, Inc.Memphis, United StatesNo longer taking part
  • St. Luke's Idaho Pulmonary Associates - Meridian ClinicMeridian, United StatesNo longer taking part
  • Desert Clinical Reserach, LLC/CCT ResearchMesa, United StatesNo longer taking part
  • Advanced Medical Research InstituteMiami, United StatesNo longer taking part
  • Flourish ResearchMiami, United StatesNo longer taking part
  • Ivetmar Medical Group, LLCMiami, United StatesNo longer taking part
  • PharmaDev Clinical Research Institute, LLCMiami, United StatesNo longer taking part
  • Sleep DynamicsNeptune City, United StatesNo longer taking part
  • Coastal Carolina Health Care, P.A. Pulmonary and Sleep MedicineNew Bern, United StatesNo longer taking part
  • Northwell HealthNew Hyde Park, United StatesNo longer taking part
  • Neurocare, Inc.Newton, United StatesNo longer taking part
  • Infinity Medical ResearchNorth Dartmouth, United StatesNo longer taking part
  • Las Vegas Clinical Trials, LLCNorth Las Vegas, United StatesNo longer taking part
  • Henry Ford Medical Center-ColumbusNovi, United StatesNo longer taking part
  • Renstar Medical ResearchOcala, United StatesNo longer taking part
  • Clinical Neuroscience Solutions, Inc.Orlando, United StatesNo longer taking part
  • Foothills Research Center Cct ResearchPhoenix, United StatesNo longer taking part
  • Empire Clinical ResearchPomona, United StatesNo longer taking part
  • Northwest Research CenterPortland, United StatesNo longer taking part
  • Probe Clinical Research CorporationRiverside, United StatesNo longer taking part
  • Onsite Clinical Solutions, LLCRock Hill, United StatesNo longer taking part
  • Velocity Clinical ResearchRockville, United StatesNo longer taking part
  • Element Research GroupSan Antonio, United StatesNo longer taking part
  • Sleep Therapy and Research CenterSan Antonio, United StatesNo longer taking part
  • Pacific Research NetworkSan Diego, United StatesNo longer taking part
  • TriValley Sleep CenterSan Ramon, United StatesNo longer taking part
  • SDS Clinical Trials, Inc.Santa Ana, United StatesNo longer taking part
  • South Ogden Family Medicine/CCT ResearchSouth Ogden, United StatesNo longer taking part
  • Baystate Clinical Trials UnitSpringfield, United StatesNo longer taking part
  • Clayton Sleep Institute, LLCSt Louis, United StatesNo longer taking part
  • Clinical Neurophysiology Services PCSterling Heights, United StatesNo longer taking part
  • Georgia Neurology and Sleep Medicine AssociatesSuwanee, United StatesNo longer taking part
  • JSV Clinical Research Study IncTampa, United StatesNo longer taking part
  • Fiel Family and Sports Medicine/CCT ResearchTempe, United StatesNo longer taking part
  • Noble Clinical ResearchTucson, United StatesNo longer taking part
  • The University of Alabama/Institute for Rural Health ResearchTuscaloosa, United StatesNo longer taking part
  • Medster ResearchValdosta, United StatesNo longer taking part
  • Sleep Disorder Center of the Mid-AtlanticVienna, United StatesNo longer taking part
  • Providere Research IncWest Covina, United StatesNo longer taking part
  • Palm Beach Research CenterWest Palm Beach, United StatesNo longer taking part
  • AccellacareWilmington, United StatesNo longer taking part
  • Central Florida Pediatric Sleep Disorders d/b/a Florida Pediatric Institute, LLCWinter Park, United StatesNo longer taking part
  • Clinical Site Partners, LLC dba Flourish ResearchWinter Park, United StatesNo longer taking part
  • Respiratory SpecialistsWyomissing, United StatesNo longer taking part

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Trial details

Who runs it
Apnimed
Trial code
NCT06566820
Record updated
13 May 2025
Original description
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.Read full original descriptionShow less

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.

Inclusion: Completion of APC-APN-304 without permanent discontinuation of IMP; Completion of APC-APN-305 without permanent discontinuation of IMP.

Exclusion: Participants are excluded from the study if participation would be considered unsafe by the investigator based on concomitant therapies; Participants are excluded from the study if participation would be considered unsafe by the investigator based on the individual's current status.

ClinicalTrials.gov NCT06566820