Clinical Trials in Denmark / 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 Denmark tracker
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
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)
- Number of subjects with treatment-emergent adverse events [Safety and Tolerability] — Up to 6 years
The safety and tolerability of ralinepag will be evaluated by the Number of subjects with treatment-emergent adverse events
Trial sites (190)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
More United Therapeutics trials in Denmark
Extension Study of Inhaled Treprostinil in Subjects With Fibrotic Lung Disease
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Other trials for the same condition
The Nordic Aortic Valve Intervention Trial 4 (NOTION-4)
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DETECTion of the Prevalence of Silent Atherosclerosis Across Adult Life - Phase I of REACT
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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 Denmark