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Clinical Trials in the USA / NCT03683186
Enrolling by invitation Phase 3

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

NCT03683186 · tracked via the Priya Life Science USA tracker
Sponsor
United Therapeutics
Phase
Phase 3
Started
2019-09-23
Last updated
2026-02-20

Condition(s) studied

PAHPulmonary HypertensionPulmonary Arterial HypertensionHypertensionConnective Tissue DiseasesFamilial Primary Pulmonary HypertensionVascular DiseasesCardiovascular DiseasesHypertension, PulmonaryLung DiseasesRespiratory Tract Disease

Investigational drug(s) / intervention(s)

Ralinepag

Ralinepag: Active

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: 1. 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. 2. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. 3. Completed the protocol-defined Study Drug Termination Visit or End of Study Visit procedures in the preceding ralinepag study. 4. 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 Criteria: 1. 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. 2. Subjects who withdrew consent during participation in another ralinepag study. 3. 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. 4. 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. 5. Subjects who had an emergency unblinding procedure in a prior Phase 2 or 3 study.

Primary outcome measure(s)

Trial sites (190)

FacilityCityRegionStatus
St. Joseph's Hospital and Medical Center-Norton Thoracic Institute Phoenix Arizona
University of Arizona Tucson Arizona
UCSD Health Sciences La Jolla California
Ronald Reagan UCLA Medical Center Los Angeles California
Keck Hospital of USC Los Angeles California
VA Greater Los Angeles Healthcare System Los Angeles California
University of California, Irvine Orange California
University of California Davis Medical Center Sacramento California
Santa Barbara Cottage Hospital Santa Barbara California
Stanford University Medical Center Stanford California
University of Colorado Hospital Aurora Colorado
National Jewish Health Denver Colorado
University of Florida Gainesville Florida
Central Florida Pulmonary Group Orlando Florida
Cleveland Clinic Florida Weston Florida
Emory University Hospital Atlanta Georgia
Piedmont Healthcare Pulmonary and Critical Care Research Austell Georgia
University of Chicago Medical Center Chicago Illinois
Ascension Alexian Brothers Elk Grove Village Illinois
Community Heart and Vascular Hospital Indianapolis Indiana
St. Vincent Medical Group, Inc. Indianapolis Indiana
University of Iowa Hospitals and Clinics Iowa City Iowa
University of Maryland Medical Center Baltimore Maryland
Tufts Medical Center Boston Massachusetts
Massachusetts General Hospital Boston Massachusetts
Boston University Medical Center Boston Massachusetts
Spectrum Health Medical Group Grand Rapids Michigan
Washington University School of Medicine St Louis Missouri
University of New Mexico Albuquerque New Mexico
NYU Langone Medical Center New York New York
University of Rochester Rochester New York
Duke University Medical Center Durham North Carolina
East Carolina University Greenville North Carolina
University of Cincinnati-Medical Science Building Cincinnati Ohio
The Ohio State University Wexner Medical Center Columbus Ohio
Integris Baptist Medical Center Oklahoma City Oklahoma
Oregon Health & Science University Portland Oregon
University of Pennsylvania Philadelphia Pennsylvania
Thomas Jefferson University Hospital Philadelphia Pennsylvania
Allegheny General Hospital Pittsburgh Pennsylvania

+ 150 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03683186 on ClinicalTrials.gov ↗ ← All trials in the USA