A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
United Therapeutics
Study ID
NCT03683186
Phase
PHASE3
Status
Enrolling By Invitation

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

Study Details

Study ROR-PH-303, ADVANCE EXTENSION, is an open-label extension (OLE) study for participants with WHO Group 1 PAH who have participated in another Phase 2 or Phase 3 study of ralinepag.

Key Dates

Start date
Sep 23, 2019
Status verified
Feb 2026
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
1,000 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Number of subjects with treatment-emergent adverse events [Safety and Tolerability] [ Time Frame: Up to 6 years ]

Locations (48)

FacilityCityStateZIPSite coordinators
St. Joseph's Hospital and Medical Center-Norton Thoracic InstitutePhoenixArizona85013-
University of ArizonaTucsonArizona85724-
UCSD Health SciencesLa JollaCalifornia92037-
Keck Hospital of USCLos AngelesCalifornia90033-
Ronald Reagan UCLA Medical CenterLos AngelesCalifornia90024-
VA Greater Los Angeles Healthcare SystemLos AngelesCalifornia90073-
University of California, IrvineOrangeCalifornia92868-
University of California Davis Medical CenterSacramentoCalifornia95817-
Santa Barbara Cottage HospitalSanta BarbaraCalifornia93105-
Stanford University Medical CenterStanfordCalifornia94305-
University of Colorado HospitalAuroraColorado80045-
National Jewish HealthDenverColorado80206-
University of FloridaGainesvilleFlorida32610-
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 Heart and Vascular HospitalIndianapolisIndiana46256-
St. Vincent Medical Group, Inc.IndianapolisIndiana46260-
University of Iowa Hospitals and ClinicsIowa CityIowa52242-
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-
University of New MexicoAlbuquerqueNew Mexico87131-
NYU Langone Medical CenterNew YorkNew York10016-
University of RochesterRochesterNew York14642-
Duke University Medical CenterDurhamNorth Carolina27710-
East Carolina UniversityGreenvilleNorth Carolina27834-
University of Cincinnati-Medical Science BuildingCincinnatiOhio45267-
The Ohio State University Wexner Medical CenterColumbusOhio43210-
Integris Baptist Medical CenterOklahoma CityOklahoma73112-
Oregon Health & Science UniversityPortlandOregon97239-
Thomas Jefferson University HospitalPhiladelphiaPennsylvania19107-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
Allegheny General HospitalPittsburghPennsylvania15212-
StatCare Pulmonary ConsultantsKnoxvilleTennessee37919-
Ascension Texas CardiovascularAustinTexas78705-
UT Southwestern Medical CenterDallasTexas75390-
Memorial Hermann HospitalHoustonTexas77030-
The Methodist Hospital Research InstituteHoustonTexas77030-
Vermont Lung CenterBurlingtonVermont05446-
Carilion Clinic Pulmonary and Sleep MedicineRoanokeVirginia24014-
Medical College of Wisconsin/Froedtert HospitalMilwaukeeWisconsin53226-

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By specialty
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By research site
St. Joseph's Hospital and Medical Center-Norton Thoracic Institute· Phoenix, AZUniversity of Arizona· Tucson, AZUCSD Health Sciences· La Jolla, CAKeck Hospital of USC· Los Angeles, CARonald Reagan UCLA Medical Center· Los Angeles, CAVA Greater Los Angeles Healthcare System· Los Angeles, CA

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