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)

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Cardiovascular Diseases; Vascular Diseases; Lung Diseases; Hypertension; Connective Tissue Diseases; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension, Pulmonary; Pulmonary Hypertension; PAH; Respiratory Tract Disease
• Intervention / Treatment: Drug: Ralinepag

Detailed Description

Study ROR-PH-303 is a multicenter, open-label extension (OLE) study for subjects with WHO Group 1 PAH who have participated in another Phase 2 or Phase 3 study of ralinepag and who qualify for entry based upon participation in the prior study. Subjects who discontinue participation in a prior study due to safety issues related to study medication or who fail to complete study procedures will not be eligible to enter Study ROR-PH-303. Subjects who meet all OLE entry criteria will be enrolled and will receive ralinepag in addition to their pre-existing PAH disease-specific background therapy.

For subjects who are enrolled from an ongoing double-blind Phase 2 or Phase 3 ralinepag study, a 16-week blinded Dose Titration Period will be completed following enrollment into the OLE. Subjects previously on ralinepag will continue on the same dose during the Dose Titration Period as received in the original study and will also initiate placebo treatment in the OLE.

Subjects who are enrolled from a non-blinded study or another OLE will not participate in the blinded Dose Titration Period in Study ROR-PH-303 but will be enrolled directly into the Treatment Period and continue on the dose of ralinepag received in the original study.

All subjects will receive ralinepag in the OLE study until premature discontinuation of ralinepag due to an AE/serious adverse event (SAE) or other reason, marketing approval of ralinepag is granted in the region in which the study is conducted, or the study is discontinued by the Sponsor.

• Study Type: Interventional
• Enrollment (Estimated): 1000
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina
    • Sanatorio de la Trinidad Mitre
  • Caba, Argentina, 1425
    • Cardiologia Palmero
  • Ciudad Autonoma Buenos Aires, Argentina, 1280
    • Hospital Británico de Buenos Aires
  • Ciudad Autonoma Buenos Aires, Argentina, C1093AAS
    • Fundacion Favaloro
  • Ciudad Autonoma Buenos Aires, Argentina, 1426
    • Fundación Respirar
  • Cordoba, Argentina, X5016KEH
    • Hospital Privado Centro Medico de Cordoba S.A
  • Corrientes, Argentina
    • Instituto de Cardiologia de Corrientes
  • Córdoba, Argentina, X5004BAL
    • Hospital Italiano de Cordoba
  • Mar Del Plata, Argentina
    • Instituto de Investigaciones Clinicas
  • Buenos Aires
    • Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina, C1181ACH
      • Hospital Italiano
  • Santa Fe
    • Rosario, Santa Fe, Argentina, S2000DSV
      • Sanatorio Parque S.A.
  • Santa Fe De La Vera Cruz
    • Santa Fe, Santa Fe De La Vera Cruz, Argentina, 3000
      • Hospital PROVINCIAL "Dr. Jose Maria Cullen"
• Australia
  • New South Wales
    • Camperdown, New South Wales, Australia, 2050
      • Royal Prince Alfred Hospital
    • Darlinghurst, New South Wales, Australia, 2010
      • St Vincent's Hospital Sydney
    • Sydney, New South Wales, Australia, 2145
      • Westmead Hospital
    • Sydney, New South Wales, Australia, 2751
      • Nepean Hospital
    • Sydney, New South Wales, Australia, 2109
      • Macquarie University
  • Queensland
    • Chermside, Queensland, Australia, 4032
      • The Prince Charles Hospital
    • Woolloongabba, Queensland, Australia, 4102
      • Princess Alexandra Hospital
  • Tasmania
    • Hobart, Tasmania, Australia, 7000
      • Royal Hobart Hospital
  • Victoria
    • Fitzroy, Victoria, Australia, 3065
      • St Vincent's Hospital Melbourne
    • Melbourne, Victoria, Australia, 3004
      • The Alfred Hospital
  • Western Australia
    • Perth, Western Australia, Australia, 6150
      • Fiona Stanley Hospital
• Austria
  • Innsbruck, Austria, A-6020
    • Medizinische Universitat Innsbruck
  • Linz, Austria, 4020
    • Ordensklinikum Linz GmbH - Elisabethinen, Fadingerstrasse 1
  • Wien, Austria, 1090
    • AKH Wien, Innere Med. II, Kardiologie, Währingergürtel 18-20
• Belgium
  • Bruxelles, Belgium, 1070
    • Cliniques Universitaires de Bruxelles Hopital Erasme
  • Leuven, Belgium, 3000
    • UZ Leuven, UZ Leuven Campus Gasthuisberg, Herestraat 49
• Brazil
  • Goias
    • Goiânia, Goias, Brazil, 74605-020
      • HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
  • MG
    • Belo Horizonte, MG, Brazil, 30441-070
      • Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa
  • R.S
    • Porto Alegre, R.S, Brazil, 90610-000
      • Hospital Sao Lucas da PUC-RS
  • RS
    • Porto Alegre, RS, Brazil, 90035-074
      • Irmandade da Santa Casa de Misericórdia de Porto Alegre
  • SP
    • Sao Paulo, SP, Brazil, 04037-002
      • Hospital Sao Paulo
    • Sao Paulo, SP, Brazil, 05403-000
      • Instituto do Coracao
  • Sao Paulo
    • Botucatu, Sao Paulo, Brazil, 18618-687
      • UNESP-Faculdade de Medicina da Universidade Estadual Paulista Campus Botucatu
• Bulgaria
  • Sofia, Bulgaria, 1309
    • MHAT - "National Heart Hospital" EAD, 65, Konyovitza Str.
  • Sofia, Bulgaria, 1750
    • MHAT "Sveta Anna" Sofia AD
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T1Y 6J4
      • Peter Lougheed Centre
    • Edmonton, Alberta, Canada, T6G 2B7
      • University of Alberta Hospital
  • Ontario
    • London, Ontario, Canada, N6A 5W9
      • LHSC - Victoria Hospital
    • Toronto, Ontario, Canada, M5G 2N2
      • University Health Network-Toronto General Hospital
  • Quebec
    • Montreal, Quebec, Canada, H3T1E2
      • SMBD Jewish General Hospital d/b/a Jewish General Hospital
    • Québec, Quebec, Canada
      • Institut universitaire de Cardiologie et de Pneumologie de Quebec
• Chile
  • Santiago De Chile
    • Providencia, Santiago De Chile, Chile, 7500691
      • Instiuto Nacional del Torax
• China
  • Beijing, China, 100037
    • Fuwai Hospital, Chinese Academy of Medical Sciences
  • Beijing
    • Beijing, Beijing, China, 100038
      • Beijing Shijitan Hospital, Capital Medical University
  • Guangdong
    • Guangzhou, Guangdong, China, 510080
      • Guangdong Provincial People's Hospital
  • Hunan
    • Changsha, Hunan, China, 410008
      • Xiangya Hospital Central South University
  • Shanghai
    • Shanghai, Shanghai, China, 200443
      • Shanghai pulmonary hospital
• Croatia
  • Zagreb, Croatia, 10000
    • Clinical Hospital Dubrava Zagreb, Avenija G.Šuška 6
  • Zagreb, Croatia, 10000
    • University Clinic for Pulmonary Diseases, Jordanovac 104
• Czechia
  • Praha 2, Czechia, 128 08
    • Vseobecna fakultni nemocnice v Praze, II. interni klinika kardiologie a angiologie VFN a 1. LF UK, U nemocnice 2
• Denmark
  • Copenhagen, Denmark, 2100
    • Copenhagen University Hospital (Rigshospitalet)
  • Århus, Denmark, 8200
    • Århus Universitetshospital
• France
  • Besançon Cedex, France, 25030
    • CHU Besançon - Hôpital Jean Minjoz
  • Brest cedex 2, France, 29609
    • CHU de Brest - Hôpital de la Cavale Blanche
  • Lille Cedex, France, 59037
    • CHRU de Lille - Hopital Cardiologique
  • Marseille, France, 13015
    • Hôpital Nord - CHU Marseille
  • Bas Rhin
    • Strasbourg, Bas Rhin, France, 67091
      • CHU de Strasbourg - Nouvel Hôpital Civil, Ctre de competence Hypertension Arterielle Pulmona, 1 place de l Hopital
  • Isere
    • Grenoble, Isere, France, 38048
      • CHU de Grenoble - Hôpital Albert Michallon, Clinique de Cardiologie, Boulevrad de la Chantourne
  • Loire
    • Saint-Étienne, Loire, France, 42005
      • CHU de Saint-Etienne - Hopital Nord, Service de Medecine vasculaire et therapeutique, 81 Avenue A. Raimond
  • Meurthe Et Moselle
    • Vandoeuvre les Nancy, Meurthe Et Moselle, France, 54511
      • CHU Nancy - Hôpital de Brabois Adultes, Pneumologie- Oncologie Médicale, Rue du Morvan
  • Rhone
    • Bron cedex, Rhone, France, 69677
      • CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel, Service de Pneumologie, 59 Boulevard Pinel
  • Seine Maritime
    • Rouen cedex, Seine Maritime, France, 76031
      • CHU de Rouen - Hôpital Charles Nicolle
  • Val De Marne
    • Le Kremlin-Bicêtre, Val De Marne, France, 94275
      • Groupement Hospitalier Sud - Hôpital Bicêtre, Service de Pneumologie, 78 Avenue du General Leclerc
• Germany
  • Donaueschingen, Germany, 78166
    • Schwarzwald-Baar Klinikum
  • Dresden, Germany, 01307
    • Universitaetsklinikum Carl Gustav Carus TU Dresden
  • Hamburg, Germany, 20246
    • Universitaetsklinikum Hamburg-Eppendorf
  • Baden-Württemberg
    • Heidelberg, Baden-Württemberg, Germany, 69126
      • Thoraxklinik-Heidelberg Zentrum für Pulmonale Hypertonie
  • Mecklenburg-Vorpommern
    • Greifswald, Mecklenburg-Vorpommern, Germany, 17475
      • Universitätsmedizin Greifswald
  • Rheinland Pfalz
    • Mainz, Rheinland Pfalz, Germany, 55131
      • Universitaetsmedizin der Johannes-Gutenberg-Universitaet Mainz, Zentrum für Kardiologie I, Centrum für Thrombose und Hämostase (CTH), Langenbeckstrasse 1
  • Saarland
    • Homburg, Saarland, Germany, 66424
      • Universitaetsklinikum des Saarlandes, Innere Medizin V, IMED, Kirrberger Strasse 100, Gebäude 41
  • Sachsen
    • Leipzig, Sachsen, Germany, 04103
      • Universitätsklinikum Leipzig, Medizinische Klinik II, Pneumologie
• Greece
  • Alexandroupolis, Greece, 68100
    • University General Hospital of Alexandroupolis
  • Athens, Greece, 17674
    • "Onasseio" Cardiosurgery Hospital, Hemodynamic Research and Interventional Cardiology Dept., 356, Syggrou Avenue
  • Chaidari, Greece, 12462
    • University General Hospital Attikon
  • Thessaloniki, Greece, 54636
    • AHEPA General Hospital of Thessaloniki, A' Cardiology Clinic, 1 St. Kyriakidi Street
• Hungary
  • Budapest, Hungary, 1096
    • Gottsegen György Országos Kardiovaszkuláris Intézet
  • Pecs, Hungary, 7624
    • Pecsi Tudomanyegyetem, Szivgyogyaszati Klinika, Ifjusag u. 13.
• Israel
  • Haifa, Israel, 3436212
    • The Lady Davis Carmel Medical Center, 7 Michal st.
  • Jerusalem, Israel, 9112001
    • Hadassah Ein Kerem Medical Center, Kiryat Hadassah
  • Kfar- Sava, Israel, 4428164
    • Meir Medical Center, 59 Tshernichovski st.
  • Petach Tikva, Israel, 4941492
    • Rabin Medical Center-Beilinson Campus, Pulmonary Institute, 39 Jabotinsky St Ground floor
  • Tel Aviv, Israel, 6423906
    • Tel Aviv Sourasky Medical Center, 6 Weizmann St.
• Italy
  • Foggia, Italy, 71100
    • Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia, S.C. di Cardiologia, Viale Luigi Pinto, 1
  • Genova, Italy, 16132
    • IRCC Ospedale Policlinico San Martino
  • Milan, Italy, 20138
    • Centro Cardiologico Monzino, IRCCS U.O. Scompenso
  • Milano, Italy, 20122
    • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico, Via Francesco Sforza 35
  • Monza, Italy, 20900
    • Azienda Socio Sanitaria Territoriale Di Monza (Presidio San Gerardo)
  • Pavia, Italy, 27100
    • Fondazione IRCCS Policlinico San Matteo
  • Roma, Italy, 00161
    • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza, Viale del Policlinico, 155
  • PA
    • Palermo, PA, Italy, 90127
      • Istituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione (ISMETT)
• Korea, Republic of
  • Gangnam-gu
    • Seoul, Gangnam-gu, Korea, Republic of, 06351
      • Samsung Medical Center
  • Jongno-gu
    • Seoul, Jongno-gu, Korea, Republic of, 03080
      • Seoul National University Hospital
  • Namdong-gu
    • Incheon, Namdong-gu, Korea, Republic of, 21565
      • Gachon University Hospital Gil Medical Center
• Mexico
  • Distrito Federal
    • Mexico, Distrito Federal, Mexico, 14080
      • Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran
    • Mexico, Distrito Federal, Mexico, 14080
      • Instituto Nacional de Cardiologia Dr Ignacio Chavez Rivera
  • Jalisco
    • Guadalajara, Jalisco, Mexico, 44160
      • CICUM San Miguel
  • N.l.
    • Monterrey, N.l., Mexico, 64718
      • Unidad de Investigación Clínica en Medicina, S.C.
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • VU Medisch Centrum, De Boelelaan 1117
• Poland
  • Bialystok, Poland, 15-276
    • Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Kardiologii z Oddzialem Intensywnego Nazdoru Kardiologicznego, M. Sklodowskiej 24a
  • Krakow, Poland, 31-202
    • Krakowski Szpital Specjalistyczny im. Jana Pawla II, Oddział Kliniczny Chorób Serca i Naczyń z Pododdziałem Intensywnego Nadzoru Kardiologicznego, Pradnicka 80
  • Otwock, Poland, 05-400
    • NZOZ Europejskie Centrum Zdrowia, ul. Borowa 14/18
  • Poznan, Poland, 61-848
    • Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Oddzial Kardiologii - F, ul. Dluga 1/2
  • Wroclaw, Poland, 50-414
    • Premium Clinic Wrocław CM, Podwale 83/17
• Portugal
  • Almada, Portugal, 2805-267
    • Hospital Garcia de Orta, E.P.E
  • Coimbra, Portugal, 3000-075
    • Centro Hospitalar e Universitário de Coimbra, E.P.E.
  • Lisboa, Portugal, 1769-001
    • Centro Hospitalar Universitário Lisboa Norte, E.P.E. Hospital Pulido Valente
  • Porto, Portugal, 4099-001
    • Centro Hospitalar de Santo António, E.P.E.
• Romania
  • Bucharest, Romania, 022328
    • Institutul de Urgenta pentru Boli Cardiovasculare "Prof. Dr. C.C. Iliescu", Sos. Fundeni nr. 258
  • Bucuresti, Romania, 050159
    • Institutul de Pneumoftiziologie "Marius Nasta", Sos. Viilor nr. 90, Sector 5
  • Cluj-Napoca, Romania, 400001
    • Institutul Inimii "Niculae Stancioiu" Cluj-Napoca, Cardiologie, Str. Motilor nr. 19-21
  • Timisoara, Romania, 300310
    • Spitalul Clinic de Boli Infectioase si Pneumoftiziologie "Dr. Victor Babes" Timisoara, Str. Gheorghe Adam nr. 13
• Serbia
  • Belgrade, Serbia, 11000
    • Clinical Center of Serbia, Koste Todorovica 8
  • Belgrade, Serbia, 11080
    • Clinical Center Zemun. Clinic for internal medicine, Department of Cardiology
  • Sremska Kamenica, Serbia, 21204
    • Institute for Pulmonary Diseases of Vojvodina, Put Dr Goldmana 4
• Singapore
  • Singapore, Singapore, 119074
    • National University Hospital
  • Singapore, Singapore, 169609
    • National Heart Centre
• Spain
  • Barcelona, Spain, 08035
    • Hospital Universitari Vall d'Hebron, Respiratory Dept., Passeig Vall d'Hebron,119-129, Neumologia
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona, C/ Villarroel, 170
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Valencia, Spain, 46026
    • Hospital Universitari i Politècnic La Fe
• Sweden
  • Göteborg, Sweden, 41345
    • Sahlgrenska Universitetssjukhuset
  • Linköping, Sweden, 58185
    • Linköping Universitetssjukhuset
  • Umeå, Sweden, 90185
    • Norrlands Universitetssjukhus, Hjärtcentrum
• Taiwan
  • Tainan, Taiwan, 704
    • National Cheng Kung University Hospital
  • Taipei, Taiwan, 10002
    • National Taiwan University Hospital
• Turkey
  • Ankara, Turkey, 06560
    • Gazi University Medical Faculty Hospital
  • Bursa, Turkey, 16059
    • Uludag Universitesi Tip Fakültesi, Gorukle Kampusu
  • Istanbul, Turkey, 34899
    • Marmara Universitesi Istanbul Pendik Egitim ve Arastirma Hastanesi, Fevzi Cakmak Mahallesi Muhsin Yazicioglu Cad. No: 10
  • Izmir, Turkey, 35340
    • Dokuz Eylul Universitesi Tip Fakultesi, Mithatpasa caddesi Inciralti Balcova
  • Odumpazari
    • Eskişehir, Odumpazari, Turkey, 26480
      • Osmangazi Uni Medical Faculty
  • Saricam
    • Adana, Saricam, Turkey, 01330
      • Balcalı, Çukurova Üniversitesi Kardiyoloji ABD
  • Yenisehir
    • Mersin, Yenisehir, Turkey, 33343
      • Mersin Üniversitesi Tip Fakültesi Ciftlikköy Kampüsü
• Ukraine
  • Dnipro, Ukraine, 49070
    • 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.
  • Kyiv, Ukraine, 03680
    • SI F.H.Yanovskyi National Institute of Phthisiology and Pulmonology of NAMSU, Clinical and Functional Dept, 10, Amosova St.
  • Lviv, Ukraine, 79010
    • 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.
• United Kingdom
  • London, United Kingdom, W12 0HS
    • Hammersmith Hospital
  • Greater London
    • London, Greater London, United Kingdom, SW3 6NP
      • Royal Brompton Hospital
    • London, Greater London, United Kingdom, NW3 2QG
      • Royal Free London NHS Foundation Trust, Pond Street
  • Tyne & Wear
    • Newcastle upon Tyne, Tyne & Wear, United Kingdom, NE7 7DN
      • The Newcastle upon Tyne Hospitals NHS Foundation Trust, Sir William Leech Lung Research Centre, Freeman Hospital
  • West Dunbartonshire
    • Glasgow, West Dunbartonshire, United Kingdom, G81 4DY
      • Golden Jubilee National Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35294
      • University of Alabama at Birmingham
  • Arizona
    • Tucson, Arizona, United States, 85724
      • University of Arizona
  • California
    • La Jolla, California, United States, 92037
      • UCSD Health Sciences
    • Loma Linda, California, United States, 92354
      • Loma Linda University Medical Center
    • Los Angeles, California, United States, 90048
      • Cedars-Sinai Medical Center
    • Los Angeles, California, United States, 90027
      • Kaiser Permanente Los Angeles Medical Center
    • Los Angeles, California, United States, 90033
      • Keck Hospital of USC
    • Los Angeles, California, United States, 90073
      • VA Greater Los Angeles Healthcare System
    • Los Angeles, California, United States, 90024
      • Ronald Reagan UCLA Medical Center
    • Orange, California, United States, 92868
      • University of California, Irvine
    • Sacramento, California, United States, 95817
      • University of California Davis Medical Center
    • Santa Barbara, California, United States, 93105
      • Santa Barbara Cottage Hospital
    • Stanford, California, United States, 94305
      • Stanford University Medical Center
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado Hospital
    • Denver, Colorado, United States, 80206
      • National Jewish Health
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida
    • Miami, Florida, United States, 33136
      • University of Miami
    • Orlando, Florida, United States, 32803
      • Central Florida Pulmonary Group
    • Orlando, Florida, United States, 32804
      • Investigational Drug Services, AdventHealth Orlando (Drug Shipment Address)
    • Weston, Florida, United States, 33331
      • Cleveland Clinic Florida
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital
    • Austell, Georgia, United States, 30106
      • Piedmont Healthcare Pulmonary and Critical Care Research
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medical Center
    • Elk Grove Village, Illinois, United States, 60007
      • Ascension Alexian Brothers
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University School of Medicine
    • Indianapolis, Indiana, United States, 46260
      • St. Vincent Medical Group, Inc.
    • Indianapolis, Indiana, United States, 46256
      • Community Heart and Vascular Hospital
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa Hospitals and Clinics
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Kentuckiana Pulmonary Research Center
  • Louisiana
    • New Orleans, Louisiana, United States, 70121
      • Ochsner Medical Center
  • Maine
    • South Portland, Maine, United States, 04106
      • Chest Medicine Associates
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • University Of Maryland Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
    • Boston, Massachusetts, United States, 02118
      • Boston University Medical Center
  • Michigan
    • Grand Rapids, Michigan, United States, 49546
      • Spectrum Health Medical Group
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • Nebraska Medical Center
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131
      • University of New Mexico
  • New York
    • Mineola, New York, United States, 11501
      • Winthrop Hospital
    • New York, New York, United States, 10029
      • Mount Sinai School of Medicine
    • New York, New York, United States, 10016
      • NYU Langone Medical Center
    • New York, New York, United States, 10021
      • Weill-Cornell-New York Presbyterian Hospital
    • Rochester, New York, United States, 14642
      • University of Rochester
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center
    • Greenville, North Carolina, United States, 27834
      • East Carolina University
  • Ohio
    • Cincinnati, Ohio, United States, 45267
      • University of Cincinnati-Medical Science Building
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic
    • Columbus, Ohio, United States, 43210
      • The Ohio State University Wexner Medical Center
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73112
      • Integris Baptist Medical Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
    • Portland, Oregon, United States, 97225
      • Oregon Clinic-Pulmonary West
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital
    • Philadelphia, Pennsylvania, United States, 19140
      • Temple University
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
  • Tennessee
    • Knoxville, Tennessee, United States, 37919
      • Statcare Pulmonary Consultants
  • Texas
    • Austin, Texas, United States, 78705
      • Ascension Texas Cardiovascular
    • Dallas, Texas, United States, 75390
      • UT Southwestern Medical Center
    • Houston, Texas, United States, 77030
      • The Methodist Hospital Research Institute
    • Houston, Texas, United States, 77030
      • Memorial Hermann Hospital
  • Vermont
    • Burlington, Vermont, United States, 05446
      • Vermont Lung Center
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • University of Virginia Medical Center
    • Norfolk, Virginia, United States, 23507
      • Sentara Cardiovascular Research Institute
    • Roanoke, Virginia, United States, 24014
      • Carilion Clinic Pulmonary and Sleep Medicine
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Medical College of Wisconsin/Froedtert Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ralinepag; Ralinepag once daily extended-release tablets (oral) 50, 250, and 400 mcg titrated to the highest tolerated dose.	Drug: Ralinepag; Active; Other Names: APD811

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: United Therapeutics

Study record dates

Study Major Dates

• Study Start (Actual): September 23, 2019
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): September 1, 2024

Study Registration Dates

• First Submitted: September 19, 2018
• First Submitted That Met QC Criteria: September 21, 2018
• First Posted (Actual): September 25, 2018

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Prostacyclin; 6 Minute Walk Test; Connective Tissue Disease-Associated; 6 Minute Walk Distance; Pulmonary Vascular Resistance; Right Ventricular Function
• Additional Relevant MeSH Terms: Hypertension; Cardiovascular Diseases; Lung Diseases; Vascular Diseases; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Hypertension, Pulmonary; Connective Tissue Diseases; Respiratory Tract Diseases
• Other Study ID Numbers: ROR-PH-303; APD811-303 (Other Identifier: Arena Pharmaceuticals)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No