Long-term study of ralinepag in people with pulmonary arterial hypertension
Continues ralinepag treatment in adults with pulmonary arterial hypertension who took part in earlier studies.
Plain-language title generated from the registry record
Registry title: A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension
Key facts
- Where
- Albuquerque, Atlanta, Aurora, Austell, Austin, Baltimore, Boston, Burlington, Chicago, Cincinnati, Columbus, Dallas, Denver, Durham, Elk Grove Village, Gainesville, Grand Rapids, Greenville, Houston, Indianapolis, Iowa City, Knoxville, La Jolla, Los Angeles, Milwaukee, New York, Oklahoma City, Orange, Orlando, Philadelphia, Phoenix, Pittsburgh, Portland, Roanoke, Rochester, Sacramento, Santa Barbara, St Louis, Stanford, Tucson, and Weston, United StatesSee the 48 sites
- Phase
- Phase 3
Where in United States
- University of New MexicoAlbuquerque, United StatesNo longer taking part
- Emory University HospitalAtlanta, United StatesNo longer taking part
- University of Colorado HospitalAurora, United StatesNo longer taking part
- Piedmont Healthcare Pulmonary and Critical Care ResearchAustell, United StatesNo longer taking part
- Ascension Texas CardiovascularAustin, United StatesNo longer taking part
- University of Maryland Medical CenterBaltimore, United StatesNo longer taking part
- Boston University Medical CenterBoston, United StatesNo longer taking part
- Massachusetts General HospitalBoston, United StatesNo longer taking part
- Tufts Medical CenterBoston, United StatesNo longer taking part
- Vermont Lung CenterBurlington, United StatesNo longer taking part
- University of Chicago Medical CenterChicago, United StatesNo longer taking part
- University of Cincinnati-Medical Science BuildingCincinnati, United StatesNo longer taking part
- The Ohio State University -Wexner Medical CenterColumbus, United StatesNo longer taking part
- UT Southwestern Medical CenterDallas, United StatesNo longer taking part
- National Jewish HealthDenver, United StatesNo longer taking part
- Duke University Medical CenterDurham, United StatesNo longer taking part
- Ascension Alexian BrothersElk Grove Village, United StatesNo longer taking part
- University of FloridaGainesville, United StatesNo longer taking part
- Spectrum Health Medical GroupGrand Rapids, United StatesNo longer taking part
- East Carolina UniversityGreenville, United StatesNo longer taking part
- Memorial Hermann HospitalHouston, United StatesNo longer taking part
- The Methodist Hospital Research InstituteHouston, United StatesNo longer taking part
- Community Heart and Vascular HospitalIndianapolis, United StatesNo longer taking part
- St. Vincent Medical Group, Inc.Indianapolis, United StatesNo longer taking part
- University of Iowa Hospitals and ClinicsIowa City, United StatesNo longer taking part
- Statcare Pulmonary ConsultantsKnoxville, United StatesNo longer taking part
- UCSD Health SciencesLa Jolla, United StatesNo longer taking part
- Keck Hospital of USCLos Angeles, United StatesNo longer taking part
- Ronald Reagan UCLA Medical CenterLos Angeles, United StatesNo longer taking part
- VA Greater Los Angeles Healthcare SystemLos Angeles, United StatesNo longer taking part
- Medical College of Wisconsin/ Froedtert HospitalMilwaukee, United StatesNo longer taking part
- NYU Langone Medical CenterNew York, United StatesNo longer taking part
- Integris Baptist Medical CenterOklahoma City, United StatesNo longer taking part
- University of California IrvineOrange, United StatesNo longer taking part
- Central Florida Pulmonary GroupOrlando, United StatesNo longer taking part
- Thomas Jefferson University HospitalPhiladelphia, United StatesNo longer taking part
- University of PennsylvaniaPhiladelphia, United StatesNo longer taking part
- St. Joseph's Hospital and Medical Center-Norton Thoracic InstitutePhoenix, United StatesNo longer taking part
- Allegheny General HospitalPittsburgh, United StatesNo longer taking part
- Oregon Health Science UniversityPortland, United StatesNo longer taking part
- Carilion Clinic Pulmonary and Sleep MedicineRoanoke, United StatesNo longer taking part
- University of RochesterRochester, United StatesNo longer taking part
- University of California, Davis Medical CenterSacramento, United StatesNo longer taking part
- Santa Barbara Cottage HospitalSanta Barbara, United StatesNo longer taking part
- Washington University School of MedicineSt Louis, United StatesNo longer taking part
- Stanford University Medical CenterStanford, United StatesNo longer taking part
- University of ArizonaTucson, United StatesNo longer taking part
- Cleveland Clinic FloridaWeston, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- United Therapeutics
- Trial code
- NCT03683186EU 2023-509305-68-00
- Record updated
- 6 October 2026
- Original description
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.Read full original descriptionShow less
A Phase 3 Open-label Extension (OLE) Study to Evaluate the Long-term Safety and Efficacy of Ralinepag in Subjects With World Health Organization (WHO) Group 1 Pulmonary Arterial Hypertension (PAH)
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.
Inclusion: Evidence of a personally signed and dated informed consent form indicating that the subject has been informed of all pertinent aspects of the study prior to initiation of any study-related procedures; Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures; Completed the protocol-defined Study Drug Termination Visit or End of Study Visit procedures in the preceding ralinepag study; Both male and female subjects agree to use a medically acceptable method of contraception throughout the entire study period from informed consent through the 30 day Follow-up Visit, if the possibility of conception exists. Eligible male and female subjects must also agree not to participate in a conception process (i.e., actively attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization) during the study and for 30 days after the last dose of ralinepag.
Exclusion: Subjects who prematurely discontinued investigational medicinal product (IMP) due to a drug-related AE/SAE or tolerability issue in the preceding ralinepag study in which they were enrolled, or subjects who did not complete all protocol defined study procedures at a Study Drug Termination Visit or End of Study Visit in the preceding ralinepag study; Subjects who had an emergency unblinding procedure in a prior Phase 2 or 3 study; Subjects who have undergone lung or heart/lung transplant or the initiation of long-term parenteral or inhaled therapy with a prostacyclin during the time since participation in their original ralinepag study; Subjects who withdrew consent during participation in another ralinepag study; Female subjects who wish to become pregnant or who have a positive pregnancy test on Day 1 (OLE Entry Visit), or are lactating or breastfeeding.