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ENROLLING BY INVITATION
NCT03683186
PHASE3

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

Sponsor: United Therapeutics

View on ClinicalTrials.gov

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

2026-02-20

Healthy Volunteers

No

Interventions

DRUG

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

Århus Universitetshospital

Aarhus, Denmark

Copenhagen University Hospital (Rigshospitalet)

Copenhagen, Denmark

CHU de Strasbourg - Nouvel Hôpital Civil, Ctre de competence Hypertension Arterielle Pulmona, 1 place de l Hopital

Strasbourg, Bas Rhin, France

CHU de Grenoble - Hôpital Albert Michallon, Clinique de Cardiologie, Boulevrad de la Chantourne

Grenoble, Isere, France

CHU Nancy - Hôpital de Brabois Adultes, Pneumologie- Oncologie Médicale, Rue du Morvan

Vandœuvre-lès-Nancy, Meurthe Et Moselle, France

CHU de Saint-Etienne - Hopital Nord, Service de Medecine vasculaire et therapeutique, 81 Avenue A. Raimond

Saint-Étienne-de-Montluc, Pays de la Loire Region, France

CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel, Service de Pneumologie, 59 Boulevard Pinel

Bron, Rhone, France

CHU de Rouen - Hôpital Charles Nicolle

Rouen, Seine Maritime, France

Groupement Hospitalier Sud - Hôpital Bicêtre, Service de Pneumologie, 78 Avenue du General Leclerc

Le Kremlin-Bicêtre, Val De Marne, France

CHU Besançon - Hôpital Jean Minjoz

Besançon, France

CHU de Brest - Hôpital de la Cavale Blanche

Brest, France

CHRU de Lille - Hopital Cardiologique

Lille, France

Hôpital Nord - CHU Marseille

Marseille, France

Thoraxklinik-Heidelberg Zentrum für Pulmonale Hypertonie

Heidelberg, Baden-Wurttemberg, Germany

Universitätsmedizin Greifswald

Greifswald, Mecklenburg-Vorpommern, Germany

Universitaetsmedizin der Johannes-Gutenberg-Universitaet Mainz, Zentrum für Kardiologie I, Centrum für Thrombose und Hämostase (CTH), Langenbeckstrasse 1

Mainz, Rhineland-Palatinate, Germany

Universitaetsklinikum des Saarlandes, Innere Medizin V, IMED, Kirrberger Strasse 100, Gebäude 41

Homburg, Saarland, Germany

Universitätsklinikum Leipzig, Medizinische Klinik II, Pneumologie

Leipzig, Saxony, Germany

Schwarzwald-Baar Klinikum

Donaueschingen, Germany

Universitaetsklinikum Carl Gustav Carus TU Dresden

Dresden, Germany

Universitaetsklinikum Hamburg-Eppendorf

Hamburg, Germany

University General Hospital of Alexandroupolis

Alexandroupoli, Greece

"Onasseio" Cardiosurgery Hospital, Hemodynamic Research and Interventional Cardiology Dept., 356, Syggrou Avenue

Athens, Greece

University General Hospital Attikon

Chaïdári, Greece

AHEPA General Hospital of Thessaloniki, A' Cardiology Clinic, 1 St. Kyriakidi Street

Thessaloniki, Greece

Gottsegen György Országos Kardiovaszkuláris Intézet

Budapest, Hungary

Pecsi Tudomanyegyetem, Szivgyogyaszati Klinika, Ifjusag u. 13.

Pécs, Hungary

The Lady Davis Carmel Medical Center, 7 Michal st.

Haifa, Israel

Hadassah Ein Kerem Medical Center, Kiryat Hadassah

Jerusalem, Israel

Meir Medical Center, 59 Tshernichovski st.

Kfar Saba, Israel

Rabin Medical Center-Beilinson Campus, Pulmonary Institute, 39 Jabotinsky St Ground floor

Petah Tikva, Israel

Tel Aviv Sourasky Medical Center, 6 Weizmann St.

Tel Aviv, Israel

Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT)

Palermo, PA, Italy

Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia, S.C. di Cardiologia, Viale Luigi Pinto, 1

Foggia, Italy

IRCC Ospedale Policlinico San Martino

Genova, Italy

Centro Cardiologico Monzino, IRCCS U.O. Scompenso

Milan, Italy

Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico, Via Francesco Sforza 35

Milan, Italy

Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)

Monza, Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza, Viale del Policlinico, 155

Roma, Italy

CICUM San Miguel

Guadalajara, Jalisco, Mexico

Instituto Nacional de Cardiologia Dr Ignacio Chavez Rivera

Mexico City, Mexico City, Mexico

Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran

Mexico City, Mexico City, Mexico

Unidad de Investigacion Clinica en Medicina, S.C.

Monterrey, N.L., Mexico

VU Medisch Centrum, De Boelelaan 1117

Amsterdam, Netherlands

Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Kardiologii z Oddzialem Intensywnego Nazdoru Kardiologicznego, M. Sklodowskiej 24a

Bialystok, Poland

Krakowski Szpital Specjalistyczny im. Jana Pawla II, Oddział Kliniczny Chorób Serca i Naczyń z Pododdziałem Intensywnego Nadzoru Kardiologicznego, Pradnicka 80

Krakow, Poland

NZOZ Europejskie Centrum Zdrowia, ul. Borowa 14/18

Otwock, Poland

Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Oddzial Kardiologii - F, ul. Dluga 1/2

Poznan, Poland

Premium Clinic Wrocław CM, Podwale 83/17

Wroclaw, Poland

Hospital Garcia de Orta, E.P.E

Almada, Portugal

Centro Hospitalar e Universitário de Coimbra, E.P.E.

Coimbra, Portugal

Centro Hospitalar Universitário Lisboa Norte, E.P.E. Hospital Pulido Valente

Lisbon, Portugal

Centro Hospitalar de Santo António, E.P.E.

Porto, Portugal

Institutul de Urgenta pentru Boli Cardiovasculare "Prof. Dr. C.C. Iliescu", Sos. Fundeni nr. 258

Bucharest, Romania

Institutul de Pneumoftiziologie "Marius Nasta", Sos. Viilor nr. 90, Sector 5

Bucharest, Romania

Institutul Inimii "Niculae Stancioiu" Cluj-Napoca, Cardiologie, Str. Motilor nr. 19-21

Cluj-Napoca, Romania

Spitalul Clinic de Boli Infectioase si Pneumoftiziologie "Dr. Victor Babes" Timisoara, Str. Gheorghe Adam nr. 13

Timișoara, Romania

Clinical Center of Serbia, Koste Todorovica 8

Belgrade, Serbia

Clinical Center Zemun. Clinic for internal medicine, Department of Cardiology

Belgrade, Serbia

Institute for Pulmonary Diseases of Vojvodina, Put Dr Goldmana 4

Kamenitz, Serbia

National University Hospital

Singapore, Singapore

National Heart Centre

Singapore, Singapore

Samsung Medical Center

Seoul, Gangnam-gu, South Korea

Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Gachon University Hospital Gil Medical Center

Incheon, Namdong-gu, South Korea

Hospital Universitari Vall d'Hebron, Respiratory Dept., Passeig Vall d'Hebron,119-129, Neumologia

Barcelona, Spain

Hospital Clinic de Barcelona, C/ Villarroel, 170

Barcelona, Spain

Hospital Universitario 12 de Octubre

Madrid, Spain

Hospital Universitari i Politecnic La Fe

Valencia, Spain

Sahlgrenska Universitetssjukhuset

Gothenburg, Sweden

Linköping Universitetssjukhuset

Linköping, Sweden

Norrlands Universitetssjukhus, Hjärtcentrum

Umeå, Sweden

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Osmangazi Uni Medical Faculty

Eskişehir, Odumpazari, Turkey (Türkiye)

Balcalı, Çukurova Üniversitesi Kardiyoloji ABD

Adana, Saricam, Turkey (Türkiye)

Mersin Üniversitesi Tip Fakültesi Ciftlikköy Kampüsü

Mersin, Yenisehir, Turkey (Türkiye)

Gazi University Medical Faculty Hospital

Ankara, Turkey (Türkiye)

Uludag Universitesi Tip Fakültesi, Gorukle Kampusu

Bursa, Turkey (Türkiye)

Marmara Universitesi Istanbul Pendik Egitim ve Arastirma Hastanesi, Fevzi Cakmak Mahallesi Muhsin Yazicioglu Cad. No: 10

Istanbul, Turkey (Türkiye)

Dokuz Eylul Universitesi Tip Fakultesi, Mithatpasa caddesi Inciralti Balcova

Izmir, Turkey (Türkiye)

CE Dniprop RCC&C Center of Dniprop RC Dept of Card SI DMA of MOHU, Chair of Internal Medicine 3, 28, Knyazya Volodymyra Velykogo St.

Dnipro, Ukraine

SI F.H.Yanovskyi National Institute of Phthisiology and Pulmonology of NAMSU, Clinical and Functional Dept, 10, Amosova St.

Kyiv, Ukraine

Communal Noncommercial Enterprise of Lviv Regional Council Lviv Clinical Hospital, Dept of Cardiology, D.Halytskyi Lviv NMU, Ch of Internal Medicine #1, 7, Chernihivska str.

Lviv, Ukraine

Royal Free London NHS Foundation Trust, Pond Street

London, Greater London, United Kingdom

Royal Brompton Hospital

London, Greater London, United Kingdom

The Newcastle upon Tyne Hospitals NHS Foundation Trust, Sir William Leech Lung Research Centre, Freeman Hospital

Newcastle upon Tyne, Tyne and Wear, United Kingdom

Golden Jubilee National Hospital

Glasgow, West Dunbartonshire, United Kingdom

Hammersmith Hospital

London, United Kingdom