Continuation Protocol for Obstructive Sleep Apnea (OSA)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Apnimed
Study ID
NCT06566820
Phase
PHASE3
Status
Enrolling By Invitation

Conditions

  • OSA

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Aroxybutynin and Atomoxetine — DRUG
    Fixed Dose Combination

Study Details

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.

Key Dates

Start date
Jul 3, 2024
Status verified
May 2025
Primary completion
Jun 30, 2026
Completion
Jun 30, 2026

Study Design

Enrollment
1,280 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER

Arms

  • Experimental: AD109
    Open Label AD109

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 ]

Locations (93)

FacilityCityStateZIPSite coordinators
Sleep Disorders Center of AmericaBirminghamAlabama35213-
The University of Alabama/Institute for Rural Health ResearchTuscaloosaAlabama35401-
Chandler Clinical TrialsChandlerArizona85224-
Desert Clinical Reserach, LLC/CCT ResearchMesaArizona85213-
Foothills Research Center/CCT ResearchPhoenixArizona85044-
Fiel Family and Sports Medicine/CCT ResearchTempeArizona85283-
Noble Clinical ResearchTucsonArizona85704-
Preferred Research Partners, Inc.Little RockArkansas72211-
Orange County Research InstituteAnaheimCalifornia92801-
Core Healthcare GroupCerritosCalifornia90703-
Exalt Clinical Research, Inc.Chula VistaCalifornia91910-
Collaborative Neuroscience Research, LLCLos AlamitosCalifornia90720-
Santa Monica Clinical TrialsLos AngelesCalifornia90025-
Empire Clinical ResearchPomonaCalifornia91767-
Probe Clinical Research CorporationRiversideCalifornia92501-
Pacific Research NetworkSan DiegoCalifornia92103-
TriValley Sleep CenterSan RamonCalifornia94583-
SDS Clinical Trials, Inc.Santa AnaCalifornia92705-
Providere Research Inc.West CovinaCalifornia91790-
Mountain View Clinical Research, Inc.DenverColorado80209-
Meris Clinical ResearchBrandonFlorida33511-
Teradan Clinical TrialsBrandonFlorida33511-
St. Francis Medical InstituteClearwaterFlorida33765-
Nouvelle Clinical ResearchCutler BayFlorida33189-
Arrow Clinical TrialsDaytona BeachFlorida32117-
Canvas Clinical ResearchLake WorthFlorida33467-
Florida Lung & Sleep AssociatesLehigh AcresFlorida33971-
Advanced Medical Research InstituteMiamiFlorida33174-
Flourish ResearchMiamiFlorida33186-
Ivetmar Medical Group, LLCMiamiFlorida33155-
PharmaDev Clinical Research Institute, LLCMiamiFlorida33176-
Renstar Medical ResearchOcalaFlorida34470-
Clinical Neuroscience Solutions, Inc.OrlandoFlorida32801-
JSV Clinical Research Study Inc.TampaFlorida33634-
Palm Beach Research CenterWest Palm BeachFlorida33409-
Central Florida Pediatric Sleep Disorders d/b/a Florida Pediatric Institute, LLCWinter ParkFlorida32789-
Clinical Site Partners, LLC dba Flourish ResearchWinter ParkFlorida32789-
Atlanta Center for Medical ResearchAtlantaGeorgia30331-
Neurotrials Research IncAtlantaGeorgia30328-
CenExel iResearch, LLCDecaturGeorgia30030-
Georgia Neurology and Sleep Medicine AssociatesSuwaneeGeorgia30024-
Medster ResearchValdostaGeorgia31605-
St. Luke's Idaho Pulmonary Associates - Meridian ClinicMeridianIdaho83642-
Chicago Research Center, Inc.ChicagoIllinois60634-
University of Kansas Medical CenterKansas CityKansas66160-
Advanced ENT and AllergyLouisvilleKentucky40220-
Centennial Medical Group Research DepartmentColumbiaMaryland21045-
Sleep Disorders Centers of the Mid-AtlanticGlen BurnieMaryland21061-
Velocity Clinical ResearchRockvilleMaryland20854-
Neurocare, Inc.NewtonMassachusetts02459-
Infinity Medical ResearchNorth DartmouthMassachusetts02747-
Baystate Clinical Trials UnitSpringfieldMassachusetts01107-
University of Michigan Clinical Research UnitAnn ArborMichigan48109-
Revive Research Institute, Inc.Lathrup VillageMichigan48076-
Henry Ford Medical Center - ColumbusNoviMichigan48377-
Clinical Neurophysiology Services PCSterling HeightsMichigan48314-
Sleep Medicine and Research Center, St. Luke's HospitalChesterfieldMissouri63017-
Healthcare Research NetworkHazelwoodMissouri63042-
Clayton Sleep Institute, LLCSt LouisMissouri63123-
Henderson Clinical TrialsHendersonNevada89052-
Las Vegas Clinical Trials, LLCNorth Las VegasNevada89030-
Clinilabs Drug Development CorporationEatontownNew Jersey07724-
Sleep DynamicsNeptune CityNew Jersey07753-
Maimonides Sleep Arts & SciencesAlbuquerqueNew Mexico87107-
Northwell HealthNew Hyde ParkNew York11042-
Research Carolina EliteDenverNorth Carolina28037-
Clinical Research of GastoniaGastoniaNorth Carolina28054-
Peters Medical Research LLCHigh PointNorth Carolina27260-
Advanced Respiratory and Sleep MedicineHuntersvilleNorth Carolina28078-
Coastal Carolina Health Care, P.A. Pulmonary and Sleep MedicineNew BernNorth Carolina28562-
AccellacareWilmingtonNorth Carolina28412-
Lillestol ResearchFargoNorth Dakota58104-
NeuroScience Research Center, LLCCantonOhio44718-
CTI Clinical Research CenterCincinnatiOhio45212-
Intrepid Research, LLCCincinnatiOhio45245-
Northwest Research CenterPortlandOregon97202-
Abington Neurological AssociatesAbingtonPennsylvania19001-
Respiratory SpecialistsWyomissingPennsylvania19610-
Lowcountry Lung and Critical Care, PACharlestonSouth Carolina29406-
Tribe Clinical Research, LLCGreenvilleSouth Carolina29607-
Velocity Clinical Research, GreenvilleGreenvilleSouth Carolina29615-
OnSite Clinical Solutions, LLCRock HillSouth Carolina29732-
Chattanooga Research & MedicineChattanoogaTennessee37404-
Clinical Neuroscience Solutions, Inc.MemphisTennessee38119-
FutureSearch Trials of NeurologyAustinTexas78731-
FutureSearch Trials of DallasDallasTexas75231-
Houston Clinical Research AssociatesHoustonTexas77070-
Memorial Hermann VillageHoustonTexas77043-
Huntsville Research InstituteHuntsvilleTexas77340-
Element Research GroupSan AntonioTexas78258-
Sleep Therapy and Research CenterSan AntonioTexas78229-
South Ogden Family Medicine/CCT ResearchSouth OgdenUtah84405-
Sleep Disorder Center of the Mid-AtlanticViennaVirginia22182-

Find similar trials in Birmingham, AL

By research site
Sleep Disorders Center of America· Birmingham, ALThe University of Alabama/Institute for Rural Health Research· Tuscaloosa, ALChandler Clinical Trials· Chandler, AZDesert Clinical Reserach, LLC/CCT Research· Mesa, AZFoothills Research Center/CCT Research· Phoenix, AZFiel Family and Sports Medicine/CCT Research· Tempe, AZ

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