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A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension
Sponsor: United Therapeutics
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.
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)
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1000
Start Date
2019-09-23
Completion Date
2026-12
Last Updated
2026-10-06
Healthy Volunteers
No
Conditions
Interventions
Ralinepag
Active
Locations (190)
St. Joseph's Hospital and Medical Center-Norton Thoracic Institute
Phoenix, Arizona, United States
University of Arizona
Tucson, Arizona, United States
UCSD Health Sciences
La Jolla, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
Keck Hospital of USC
Los Angeles, California, United States
VA Greater Los Angeles Healthcare System
Los Angeles, California, United States
University of California, Irvine
Orange, California, United States
University of California Davis Medical Center
Sacramento, California, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, United States
Stanford University Medical Center
Stanford, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
National Jewish Health
Denver, Colorado, United States
University of Florida
Gainesville, Florida, United States
Central Florida Pulmonary Group
Orlando, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Piedmont Healthcare Pulmonary and Critical Care Research
Austell, Georgia, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Ascension Alexian Brothers
Elk Grove Village, Illinois, United States
Community Heart and Vascular Hospital
Indianapolis, Indiana, United States
St. Vincent Medical Group, Inc.
Indianapolis, Indiana, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
University of Maryland Medical Center
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Boston University Medical Center
Boston, Massachusetts, United States
Spectrum Health Medical Group
Grand Rapids, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of New Mexico
Albuquerque, New Mexico, United States
NYU Langone Medical Center
New York, New York, United States
University of Rochester
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
East Carolina University
Greenville, North Carolina, United States
University of Cincinnati-Medical Science Building
Cincinnati, Ohio, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, United States
Oregon Health & Science University
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
StatCare Pulmonary Consultants
Knoxville, Tennessee, United States
Ascension Texas Cardiovascular
Austin, Texas, United States
UT Southwestern Medical Center
Dallas, Texas, United States
Memorial Hermann Hospital
Houston, Texas, United States
The Methodist Hospital Research Institute
Houston, Texas, United States
Vermont Lung Center
Burlington, Vermont, United States
Carilion Clinic Pulmonary and Sleep Medicine
Roanoke, Virginia, United States
Medical College of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin, United States
Hospital Italiano
Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina
Hospital PROVINCIAL "Dr. Jose Maria Cullen"
Santa Fe, Santa Fe de La Vera Cruz, Argentina
Sanatorio Parque
Rosario, Santa Fe Province, Argentina
Sanatorio de la Trinidad Mitre
Buenos Aires, Argentina
Cardiologia Palmero
Caba, Argentina
Hospital Britanico de Buenos Aires
Ciudad Autonoma Buenos Aires, Argentina
Fundacion Respirar
Ciudad Autonoma Buenos Aires, Argentina
Fundacion Favaloro
Ciudad Autonoma Buenos Aires, Argentina
Instituto de Cardiologia de Corrientes
Corrientes, Argentina
Hospital Italiano de Cordoba
Córdoba, Argentina
Hospital Privado Centro Medico de Cordoba S.A
Córdoba, Argentina
Instituto de Investigaciones Clinicas
Mar del Plata, Argentina
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia
Macquarie University
Sydney, New South Wales, Australia
Westmead Hospital
Sydney, New South Wales, Australia
Nepean Hospital
Sydney, New South Wales, Australia
The Prince Charles Hospital
Chermside, Queensland, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Royal Hobart Hospital
Hobart, Tasmania, Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Fiona Stanley Hospital
Perth, Western Australia, Australia
Medizinische Universität Innsbruck
Innsbruck, Austria
Ordensklinikum Linz GmbH - Elisabethinen, Fadingerstrasse 1
Linz, Austria
AKH Wien, Innere Med. II, Kardiologie, Währingergürtel 18-20
Vienna, Austria
Cliniques Universitaires de Bruxelles Hopital Erasme
Brussels, Belgium
UZ Leuven, UZ Leuven Campus Gasthuisberg, Herestraat 49
Leuven, Belgium
HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
Goiânia, Goiás, Brazil
Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa
Belo Horizonte, Minas Gerais, Brazil
Hospital Sao Lucas da PUC-RS
Porto Alegre, R.S, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
UNESP-Faculdade de Medicina da Universidade Estadual Paulista Campus Botucatu
Botucatu, São Paulo, Brazil
Hospital Sao Paulo
São Paulo, São Paulo, Brazil
Instituto do Coracao
São Paulo, São Paulo, Brazil
MHAT - "National Heart Hospital" EAD, 65, Konyovitza Str.
Sofia, Bulgaria
MHAT "Sveta Anna" Sofia AD
Sofia, Bulgaria
Peter Lougheed Centre
Calgary, Alberta, Canada
University of Alberta Hospital
Edmonton, Alberta, Canada
LHSC - Victoria Hospital
London, Ontario, Canada
University Health Network-Toronto General Hospital
Toronto, Ontario, Canada
SMBD Jewish General Hospital d/b/a Jewish General Hospital
Montreal, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Québec, Quebec, Canada
Instiuto Nacional del Torax
Providencia, Santiago de Chile, Chile
Beijing Shijitan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China
Xiangya Hospital Central South University
Changsha, Hunan, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, China
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, China
Clinical Hospital Dubrava Zagreb, Avenija G.Šuška 6
Zagreb, Croatia
University Clinic for Pulmonary Diseases, Jordanovac 104
Zagreb, Croatia
Vseobecna fakultni nemocnice v Praze, II. interni klinika kardiologie a angiologie VFN a 1. LF UK, U nemocnice 2
Prague, Czechia