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Enrolling by invitationPhase 3

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.

Key facts

Who runs it
United Therapeutics
Where
Calgary, Edmonton, London, Montreal, Québec, and Toronto, CanadaSee the 6 sitesAlso in 32 other countries, 171 sites
Registry title
A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension
Status
Enrolling by invitation
Phase
Phase 3
People taking part
1,000 people, planned
Started
23 Sept 2019
Expected to end
Dec 2026
Type of study
Interventional
Treatments tested
  • Ralinepag
Record updated
6 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with WHO Group 1 pulmonary arterial hypertension (PAH) who finished an earlier ralinepag study and want to continue ralinepag.

Age
18 years or older
Sex
Men and women can join.
Disease stage
WHO Group 1 pulmonary arterial hypertension (PAH).
Earlier treatment
Must have completed the final visits of an earlier ralinepag study. Must not have stopped that study early because of a drug-related side effect or tolerability problem.

Main reasons for not taking part

  • Stopped the earlier ralinepag study early because of a drug-related side effect or tolerability problem
  • Withdrew consent during another ralinepag study
  • Wants to become pregnant, has a positive pregnancy test on Day 1, or is breastfeeding
  • Had a lung or heart/lung transplant since the earlier ralinepag study
  • Started long-term prostacyclin treatment by injection or inhalation since the earlier ralinepag study

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Canada

Also in 32 other countries, 171 sites

  • Peter Lougheed CentreCalgary, CanadaNo longer taking part
  • University of Alberta HospitalEdmonton, CanadaNo longer taking part
  • LHSC Victoria HospitalLondon, CanadaNo longer taking part
  • SMBD Jewish General Hospital d/b/a Jewish General HospitalMontreal, CanadaNo longer taking part
  • Institut universitaire de cardiologie et de pneumologie de QuébecQuébec, CanadaNo longer taking part
  • University Health Network, Toronto General HospitalToronto, CanadaNo longer taking part

About the trial

What the trial wants to find out

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.

The group in the trial

  • RalinepagTreatment being tested

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

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

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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)
Plain-language title
Long-term study of ralinepag in people with pulmonary arterial hypertensionGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
6 October 2026