A Study Evaluating the Long-Term Efficacy and Safety of Ralinepag in Subjects With PAH Via an Open-Label Extension
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)
2 other identifiers
interventional
1,000
31 countries
184
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2019
Longer than P75 for phase_3
184 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 19, 2018
CompletedFirst Posted
Study publicly available on registry
September 25, 2018
CompletedStudy Start
First participant enrolled
September 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
February 20, 2026
February 1, 2026
7.2 years
September 19, 2018
February 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of subjects with treatment-emergent adverse events [Safety and Tolerability]
The safety and tolerability of ralinepag will be evaluated by the Number of subjects with treatment-emergent adverse events
Up to 6 years
Study Arms (1)
Ralinepag
EXPERIMENTALRalinepag once daily extended-release tablets (oral) 50, 250, and 400 mcg titrated to the highest tolerated dose.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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 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.
- 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 had an emergency unblinding procedure in a prior Phase 2 or 3 study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (190)
St. Joseph's Hospital and Medical Center-Norton Thoracic Institute
Phoenix, Arizona, 85013, United States
University of Arizona
Tucson, Arizona, 85724, United States
UCSD Health Sciences
La Jolla, California, 92037, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90024, United States
Keck Hospital of USC
Los Angeles, California, 90033, United States
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073, United States
University of California, Irvine
Orange, California, 92868, United States
University of California Davis Medical Center
Sacramento, California, 95817, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, 93105, United States
Stanford University Medical Center
Stanford, California, 94305, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
National Jewish Health
Denver, Colorado, 80206, United States
University of Florida
Gainesville, Florida, 32610, United States
Central Florida Pulmonary Group
Orlando, Florida, 32803, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Piedmont Healthcare Pulmonary and Critical Care Research
Austell, Georgia, 30106, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Ascension Alexian Brothers
Elk Grove Village, Illinois, 60007, United States
Community Heart and Vascular Hospital
Indianapolis, Indiana, 46256, United States
St. Vincent Medical Group, Inc.
Indianapolis, Indiana, 46260, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Boston University Medical Center
Boston, Massachusetts, 02118, United States
Spectrum Health Medical Group
Grand Rapids, Michigan, 49546, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
NYU Langone Medical Center
New York, New York, 10016, United States
University of Rochester
Rochester, New York, 14642, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
East Carolina University
Greenville, North Carolina, 27834, United States
University of Cincinnati-Medical Science Building
Cincinnati, Ohio, 45267, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
StatCare Pulmonary Consultants
Knoxville, Tennessee, 37919, United States
Ascension Texas Cardiovascular
Austin, Texas, 78705, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Memorial Hermann Hospital
Houston, Texas, 77030, United States
The Methodist Hospital Research Institute
Houston, Texas, 77030, United States
Vermont Lung Center
Burlington, Vermont, 05446, United States
Carilion Clinic Pulmonary and Sleep Medicine
Roanoke, Virginia, 24014, United States
Medical College of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin, 53226, United States
Hospital Italiano
Ciudad Autonoma de Buenos Aires, Buenos Aires, C1181ACH, Argentina
Hospital PROVINCIAL "Dr. Jose Maria Cullen"
Santa Fe, Santa Fe de La Vera Cruz, 3000, Argentina
Sanatorio Parque
Rosario, Santa Fe Province, 2000, Argentina
Sanatorio de la Trinidad Mitre
Buenos Aires, Argentina
Cardiologia Palmero
Caba, 1425, Argentina
Hospital Britanico de Buenos Aires
Ciudad Autonoma Buenos Aires, 1280, Argentina
Fundacion Respirar
Ciudad Autonoma Buenos Aires, 1426, Argentina
Fundacion Favaloro
Ciudad Autonoma Buenos Aires, C1093AAS, Argentina
Instituto de Cardiologia de Corrientes
Corrientes, Argentina
Hospital Italiano de Cordoba
Córdoba, X5004BAL, Argentina
Hospital Privado Centro Medico de Cordoba S.A
Córdoba, X5016KEH, Argentina
Instituto de Investigaciones Clinicas
Mar del Plata, Argentina
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010, Australia
Macquarie University
Sydney, New South Wales, 2109, Australia
Westmead Hospital
Sydney, New South Wales, 2145, Australia
Nepean Hospital
Sydney, New South Wales, 2751, Australia
The Prince Charles Hospital
Chermside, Queensland, 4032, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Royal Hobart Hospital
Hobart, Tasmania, 7000, Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Fiona Stanley Hospital
Perth, Western Australia, 6150, Australia
Medizinische Universität Innsbruck
Innsbruck, A-6020, Austria
Ordensklinikum Linz GmbH - Elisabethinen, Fadingerstrasse 1
Linz, 4020, Austria
AKH Wien, Innere Med. II, Kardiologie, Währingergürtel 18-20
Vienna, 1090, Austria
Cliniques Universitaires de Bruxelles Hopital Erasme
Brussels, 1070, Belgium
UZ Leuven, UZ Leuven Campus Gasthuisberg, Herestraat 49
Leuven, 3000, Belgium
HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
Goiânia, Goiás, 74605-020, Brazil
Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa
Belo Horizonte, Minas Gerais, 30441-070, Brazil
Hospital Sao Lucas da PUC-RS
Porto Alegre, R.S, 90610-000, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-074, Brazil
UNESP-Faculdade de Medicina da Universidade Estadual Paulista Campus Botucatu
Botucatu, São Paulo, 18618-687, Brazil
Hospital Sao Paulo
São Paulo, São Paulo, 04037-002, Brazil
Instituto do Coracao
São Paulo, São Paulo, 05403-000, Brazil
MHAT - "National Heart Hospital" EAD, 65, Konyovitza Str.
Sofia, 1309, Bulgaria
MHAT "Sveta Anna" Sofia AD
Sofia, 1750, Bulgaria
Peter Lougheed Centre
Calgary, Alberta, T1Y 6J4, Canada
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
LHSC - Victoria Hospital
London, Ontario, N6A 5W9, Canada
University Health Network-Toronto General Hospital
Toronto, Ontario, M5G 2N2, Canada
SMBD Jewish General Hospital d/b/a Jewish General Hospital
Montreal, Quebec, H3T1E2, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Québec, Quebec, Canada
Instiuto Nacional del Torax
Providencia, Santiago de Chile, 7500691, Chile
Beijing Shijitan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100038, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080, China
Xiangya Hospital Central South University
Changsha, Hunan, 410008, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200443, China
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, 100037, China
Clinical Hospital Dubrava Zagreb, Avenija G.Šuška 6
Zagreb, 10000, Croatia
University Clinic for Pulmonary Diseases, Jordanovac 104
Zagreb, 10000, Croatia
Vseobecna fakultni nemocnice v Praze, II. interni klinika kardiologie a angiologie VFN a 1. LF UK, U nemocnice 2
Prague, 128 08, Czechia
Århus Universitetshospital
Aarhus, 8200, Denmark
Copenhagen University Hospital (Rigshospitalet)
Copenhagen, 2100, Denmark
CHU de Strasbourg - Nouvel Hôpital Civil, Ctre de competence Hypertension Arterielle Pulmona, 1 place de l Hopital
Strasbourg, Bas Rhin, 67091, France
CHU de Grenoble - Hôpital Albert Michallon, Clinique de Cardiologie, Boulevrad de la Chantourne
Grenoble, Isere, 38048, France
CHU Nancy - Hôpital de Brabois Adultes, Pneumologie- Oncologie Médicale, Rue du Morvan
Vandœuvre-lès-Nancy, Meurthe Et Moselle, 54511, 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, 42005, France
CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel, Service de Pneumologie, 59 Boulevard Pinel
Bron, Rhone, 69677, France
CHU de Rouen - Hôpital Charles Nicolle
Rouen, Seine Maritime, 76031, France
Groupement Hospitalier Sud - Hôpital Bicêtre, Service de Pneumologie, 78 Avenue du General Leclerc
Le Kremlin-Bicêtre, Val De Marne, 94275, France
CHU Besançon - Hôpital Jean Minjoz
Besançon, 25030, France
CHU de Brest - Hôpital de la Cavale Blanche
Brest, 29609, France
CHRU de Lille - Hopital Cardiologique
Lille, 59037, France
Hôpital Nord - CHU Marseille
Marseille, 13015, France
Thoraxklinik-Heidelberg Zentrum für Pulmonale Hypertonie
Heidelberg, Baden-Wurttemberg, 69126, Germany
Universitätsmedizin Greifswald
Greifswald, Mecklenburg-Vorpommern, 17475, Germany
Universitaetsmedizin der Johannes-Gutenberg-Universitaet Mainz, Zentrum für Kardiologie I, Centrum für Thrombose und Hämostase (CTH), Langenbeckstrasse 1
Mainz, Rhineland-Palatinate, 55131, Germany
Universitaetsklinikum des Saarlandes, Innere Medizin V, IMED, Kirrberger Strasse 100, Gebäude 41
Homburg, Saarland, 66424, Germany
Universitätsklinikum Leipzig, Medizinische Klinik II, Pneumologie
Leipzig, Saxony, 04103, Germany
Schwarzwald-Baar Klinikum
Donaueschingen, 78166, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, 01307, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
University General Hospital of Alexandroupolis
Alexandroupoli, 68100, Greece
"Onasseio" Cardiosurgery Hospital, Hemodynamic Research and Interventional Cardiology Dept., 356, Syggrou Avenue
Athens, 17674, Greece
University General Hospital Attikon
Chaïdári, 12462, Greece
AHEPA General Hospital of Thessaloniki, A' Cardiology Clinic, 1 St. Kyriakidi Street
Thessaloniki, 54636, Greece
Gottsegen György Országos Kardiovaszkuláris Intézet
Budapest, 1096, Hungary
Pecsi Tudomanyegyetem, Szivgyogyaszati Klinika, Ifjusag u. 13.
Pécs, 7624, Hungary
The Lady Davis Carmel Medical Center, 7 Michal st.
Haifa, 3436212, Israel
Hadassah Ein Kerem Medical Center, Kiryat Hadassah
Jerusalem, 9112001, Israel
Meir Medical Center, 59 Tshernichovski st.
Kfar Saba, 4428164, Israel
Rabin Medical Center-Beilinson Campus, Pulmonary Institute, 39 Jabotinsky St Ground floor
Petah Tikva, 4941492, Israel
Tel Aviv Sourasky Medical Center, 6 Weizmann St.
Tel Aviv, 6423906, Israel
Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT)
Palermo, PA, 90127, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia, S.C. di Cardiologia, Viale Luigi Pinto, 1
Foggia, 71100, Italy
IRCC Ospedale Policlinico San Martino
Genova, 16132, Italy
Centro Cardiologico Monzino, IRCCS U.O. Scompenso
Milan, 20138, Italy
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico, Via Francesco Sforza 35
Milan, 20122, Italy
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
Monza, 20900, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100, Italy
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza, Viale del Policlinico, 155
Roma, 00161, Italy
CICUM San Miguel
Guadalajara, Jalisco, 44160, Mexico
Instituto Nacional de Cardiologia Dr Ignacio Chavez Rivera
Mexico City, Mexico City, 14080, Mexico
Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran
Mexico City, Mexico City, 14080, Mexico
Unidad de Investigacion Clinica en Medicina, S.C.
Monterrey, N.L., 64718, Mexico
VU Medisch Centrum, De Boelelaan 1117
Amsterdam, 1081 HV, Netherlands
Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Kardiologii z Oddzialem Intensywnego Nazdoru Kardiologicznego, M. Sklodowskiej 24a
Bialystok, 15-276, Poland
Krakowski Szpital Specjalistyczny im. Jana Pawla II, Oddział Kliniczny Chorób Serca i Naczyń z Pododdziałem Intensywnego Nadzoru Kardiologicznego, Pradnicka 80
Krakow, 31-202, Poland
NZOZ Europejskie Centrum Zdrowia, ul. Borowa 14/18
Otwock, 05-400, Poland
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Oddzial Kardiologii - F, ul. Dluga 1/2
Poznan, 61-848, Poland
Premium Clinic Wrocław CM, Podwale 83/17
Wroclaw, 50-414, Poland
Hospital Garcia de Orta, E.P.E
Almada, 2805-267, Portugal
Centro Hospitalar e Universitário de Coimbra, E.P.E.
Coimbra, 3000-075, Portugal
Centro Hospitalar Universitário Lisboa Norte, E.P.E. Hospital Pulido Valente
Lisbon, 1769-001, Portugal
Centro Hospitalar de Santo António, E.P.E.
Porto, 4099-001, Portugal
Institutul de Urgenta pentru Boli Cardiovasculare "Prof. Dr. C.C. Iliescu", Sos. Fundeni nr. 258
Bucharest, 022328, Romania
Institutul de Pneumoftiziologie "Marius Nasta", Sos. Viilor nr. 90, Sector 5
Bucharest, 050159, Romania
Institutul Inimii "Niculae Stancioiu" Cluj-Napoca, Cardiologie, Str. Motilor nr. 19-21
Cluj-Napoca, 400001, Romania
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie "Dr. Victor Babes" Timisoara, Str. Gheorghe Adam nr. 13
Timișoara, 300310, Romania
Clinical Center of Serbia, Koste Todorovica 8
Belgrade, 11000, Serbia
Clinical Center Zemun. Clinic for internal medicine, Department of Cardiology
Belgrade, 11080, Serbia
Institute for Pulmonary Diseases of Vojvodina, Put Dr Goldmana 4
Kamenitz, 21204, Serbia
National University Hospital
Singapore, 119074, Singapore
National Heart Centre
Singapore, 169609, Singapore
Samsung Medical Center
Seoul, Gangnam-gu, 06351, South Korea
Seoul National University Hospital
Seoul, Jongno-gu, 03080, South Korea
Gachon University Hospital Gil Medical Center
Incheon, Namdong-gu, 21565, South Korea
Hospital Universitari Vall d'Hebron, Respiratory Dept., Passeig Vall d'Hebron,119-129, Neumologia
Barcelona, 08035, Spain
Hospital Clinic de Barcelona, C/ Villarroel, 170
Barcelona, 08036, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
Sahlgrenska Universitetssjukhuset
Gothenburg, 41345, Sweden
Linköping Universitetssjukhuset
Linköping, 58185, Sweden
Norrlands Universitetssjukhus, Hjärtcentrum
Umeå, 90185, Sweden
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Osmangazi Uni Medical Faculty
Eskişehir, Odumpazari, 26480, Turkey (Türkiye)
Balcalı, Çukurova Üniversitesi Kardiyoloji ABD
Adana, Saricam, 01330, Turkey (Türkiye)
Mersin Üniversitesi Tip Fakültesi Ciftlikköy Kampüsü
Mersin, Yenisehir, 33343, Turkey (Türkiye)
Gazi University Medical Faculty Hospital
Ankara, 06560, Turkey (Türkiye)
Uludag Universitesi Tip Fakültesi, Gorukle Kampusu
Bursa, 16059, Turkey (Türkiye)
Marmara Universitesi Istanbul Pendik Egitim ve Arastirma Hastanesi, Fevzi Cakmak Mahallesi Muhsin Yazicioglu Cad. No: 10
Istanbul, 34899, Turkey (Türkiye)
Dokuz Eylul Universitesi Tip Fakultesi, Mithatpasa caddesi Inciralti Balcova
Izmir, 35340, 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, 49070, Ukraine
SI F.H.Yanovskyi National Institute of Phthisiology and Pulmonology of NAMSU, Clinical and Functional Dept, 10, Amosova St.
Kyiv, 03680, 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, 79010, Ukraine
Royal Free London NHS Foundation Trust, Pond Street
London, Greater London, NW3 2QG, United Kingdom
Royal Brompton Hospital
London, Greater London, SW3 6NP, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust, Sir William Leech Lung Research Centre, Freeman Hospital
Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom
Golden Jubilee National Hospital
Glasgow, West Dunbartonshire, G81 4DY, United Kingdom
Hammersmith Hospital
London, W12 0HS, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 19, 2018
First Posted
September 25, 2018
Study Start
September 23, 2019
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
February 20, 2026
Record last verified: 2026-02