A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
United Therapeutics
Study ID
NCT03626688
Phase
PHASE3
Status
Completed

Conditions

  • Cardiovascular Diseases
  • Connective Tissue Diseases
  • Familial Primary Pulmonary Hypertension
  • Hypertension
  • Hypertension, Pulmonary
  • Lung Diseases
  • PAH
  • Pulmonary Arterial Hypertension
  • Pulmonary Hypertension
  • Respiratory Tract Disease
  • Vascular Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ralinepag — DRUG
    Active
  • Placebo — DRUG
    Placebo

Study Details

Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.

Key Dates

Start date
Aug 30, 2018
Status verified
Apr 2026
Primary completion
Dec 31, 2025
Completion
Dec 31, 2025

Study Design

Enrollment
687 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ralinepag
    Ralinepag once daily extended-release tablets (oral) 50, 250, and 400 mcg titrated to the highest tolerated dose.
  • Placebo Comparator: Placebo
    Matching placebo tablets (oral)

Primary Outcome Measure

Time from randomization to the first adjudicated protocol-defined clinical worsening event [ Time Frame: The study duration was event-based. This parameter was assessed from randomization until the conclusion of the study, up to 3 years ]

Locations (68)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
St. Joseph's Hospital and Medical CenterPhoenixArizona85013-
University of ArizonaTucsonArizona85724-
UCSD Health SciencesLa JollaCalifornia92037-
Loma Linda University Medical CenterLoma LindaCalifornia92354-
Cedars-Sinai Medical CenterLos AngelesCalifornia90048-
Kaiser Permanente Los Angeles Medical CenterLos AngelesCalifornia90027-
Keck Hospital of USCLos AngelesCalifornia90033-
Ronald Reagan UCLA Medical CenterLos AngelesCalifornia90024-
VA Greater Los Angeles Healthcare SystemLos AngelesCalifornia90073-
University of California, IrvineOrangeCalifornia19103-
University of California Davis Medical CenterSacramentoCalifornia95817-
SBPA Research LLCSanta BarbaraCalifornia93105-
Stanford HealthcareStanfordCalifornia94305-
LA Biomedical Research Institute Harbor-UCLA Medical CenterTorranceCalifornia90502-
University of Colorado HospitalAuroraColorado80045-
National Jewish HealthDenverColorado80206-
University of FloridaGainesvilleFlorida32610-
University of MiamiMiamiFlorida33136-
Central Florida Pulmonary GroupOrlandoFlorida32803-
Cleveland Clinic FloridaWestonFlorida33331-
Emory University HospitalAtlantaGeorgia30322-
Piedmont Healthcare Pulmonary and Critical Care ResearchAustellGeorgia30106-
University of Chicago Medical CenterChicagoIllinois60637-
Ascension Alexian BrothersElk Grove VillageIllinois60007-
Community Health Network Cancer Center NorthIndianapolisIndiana46250-
Indiana University School of MedicineIndianapolisIndiana46202-
St. Vincent Medical Group, Inc.IndianapolisIndiana46260-
University of Iowa Hospitals and ClinicsIowa CityIowa52242-
Kentuckiana Pulmonary Research CenterLouisvilleKentucky40202-
Ochsner Medical CenterNew OrleansLouisiana70121-
Chest Medicine AssociatesSouth PortlandMaine04106-
University of Maryland Medical CenterBaltimoreMaryland21201-
Boston University Medical CenterBostonMassachusetts02118-
Massachusetts General HospitalBostonMassachusetts02114-
Tufts Medical CenterBostonMassachusetts02111-
Spectrum Health Medical GroupGrand RapidsMichigan49546-
Washington University School of MedicineSt LouisMissouri63110-
Nebraska Medical CenterOmahaNebraska68198-
University of New MexicoAlbuquerqueNew Mexico87131-
Winthrop HospitalMineolaNew York11501-
Mount Sinai School of MedicineNew YorkNew York10029-
NYU Langone Medical CenterNew YorkNew York10016-
Weill-Cornell-New York Presbyterian HospitalNew YorkNew York10021-
University of RochesterRochesterNew York14642-
Duke University Medical CenterDurhamNorth Carolina27710-
East Carolina UniversityGreenvilleNorth Carolina27834-
University of Cincinnati-Medical Science BuildingCincinnatiOhio45267-
Cleveland ClinicClevelandOhio44195-
The Ohio State University Wexner Medical CenterColumbusOhio43210-
Integris Baptist Medical CenterOklahoma CityOklahoma73112-
Oregon Clinic-Pulmonary WestPortlandOregon97225-
Oregon Health & Science UniversityPortlandOregon97239-
Temple UniversityPhiladelphiaPennsylvania19140-
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
Allegheny General HospitalPittsburghPennsylvania15212-
Statcare Pulmonary ConsultantsKnoxvilleTennessee37919-
Ascension Texas CardiovascularAustinTexas78705-
Baylor University Medical CenterDallasTexas75246-
UT Southwestern Medical CenterDallasTexas75390-
Memorial Hermann HospitalHoustonTexas77030-
The Methodist Hospital Research InstituteHoustonTexas77030-
Vermont Lung CenterColchesterVermont05446-
University of Virginia Medical CenterCharlottesvilleVirginia22908-
Sentara Cardiovascular Research InstituteNorfolkVirginia23507-
Carilion Clinic Pulmonary and Sleep MedicineRoanokeVirginia24014-
Medical College of Wisconsin/Froedtert HospitalMilwaukeeWisconsin53226-

Find similar trials in Birmingham, AL

By condition
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By specialty
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By research site
University of Alabama at Birmingham· Birmingham, ALSt. Joseph's Hospital and Medical Center· Phoenix, AZUniversity of Arizona· Tucson, AZUCSD Health Sciences· La Jolla, CALoma Linda University Medical Center· Loma Linda, CACedars-Sinai Medical Center· Los Angeles, CA

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