A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients

April 17, 2024 updated by: United Therapeutics

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Ralinepag When Added to PAH Standard of Care or PAH Specific Background Therapy in Subjects With WHO Group 1 PAH

Study ROR-PH-301, ADVANCE OUTCOMES, is designed to assess the efficacy and safety of ralinepag when added to pulmonary arterial hypertension (PAH) standard of care or PAH-specific background therapy in subjects with World Health Organization (WHO) Group 1 PAH.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Study ROR-PH-301 is a multicenter, randomized, double-blind, placebo-controlled study. Subjects who meet entry criteria will be randomly allocated 1:1 to receive ralinepag or placebo, in addition to their standard of care or PAH-specific background therapy, as applicable. The primary endpoint is the time (in days) from randomization to the first adjudicated protocol-defined clinical worsening event. All primary endpoint events will be adjudicated by an independent Clinical Event Committee (CEC) in a blinded fashion. Subjects who have a confirmed primary endpoint event adjudicated by the CEC at any time during the study and all subjects on treatment at the conclusion of the study who have completed the Week 28 Visit (after the target number of confirmed events is achieved) will have the option to enroll in an open-label extension (OLE) study. Subjects who do not choose to participate in the OLE study will discontinue study drug and should remain in the study for long-term follow-up of survival status and will receive standard of care PAH treatment, at the discretion of the treating physician.

Study Type

Interventional

Enrollment (Estimated)

1000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1039AAO
        • Recruiting
        • Sanatorio de la Trinidad Mitre
        • Principal Investigator:
          • Guillermo Bortman, MD
        • Contact:
      • Caba, Argentina, 1425
        • Recruiting
        • Cardiologia Palmero
        • Contact:
        • Principal Investigator:
          • Adrian J Lescano
      • Ciudad Autonoma Buenos Aires, Argentina, 1280
        • Recruiting
        • Hospital Britanico de Buenos Aires
        • Contact:
        • Principal Investigator:
          • Dr. Felipe Chertcoff
      • Ciudad Autonoma Buenos Aires, Argentina, C1093AAS
        • Recruiting
        • Fundacion Favaloro
        • Contact:
        • Principal Investigator:
          • Jorge Osvaldo Caneva, MD
      • Ciudad Autonoma Buenos Aires, Argentina, 1426
        • Completed
        • Fundación Respirar
      • Cordoba, Argentina, X5004BAL
        • Recruiting
        • Hospital Italiano de Cordoba
        • Contact:
        • Principal Investigator:
          • Daniela Garcia Brasca, MD
      • Cordoba, Argentina, X5016KEH
        • Recruiting
        • Hospital Privado Centro Medico de Cordoba S.A
        • Contact:
        • Principal Investigator:
          • Dr. Marcos Amuchastegui
      • Corrientes, Argentina
        • Recruiting
        • Instituto de Cardiologia de Corrientes
        • Principal Investigator:
          • Eduardo Roque Perna, MD
        • Contact:
      • Santa Fe, Argentina, 3000
        • Recruiting
        • Hospital PROVINCIAL "Dr. Jose Maria Cullen"
        • Principal Investigator:
          • Cristian E Botta
        • Contact:
    • Buenos Aires
      • Ciudad Autonoma Buenos Aires, Buenos Aires, Argentina, C1181ACH
        • Recruiting
        • Hospital Italiano
        • Principal Investigator:
          • Graciela Svetliza, MD
        • Contact:
      • Mar Del Plata, Buenos Aires, Argentina, 7600
        • Recruiting
        • Instituto de Investigaciones Clinicas Mar del Plata
        • Contact:
        • Principal Investigator:
          • Pablo Martinez Monferrán, MD
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000DSV
        • Recruiting
        • Sanatorio Parque S.A.
        • Contact:
        • Principal Investigator:
          • Fabian Diez, MD
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Active, not recruiting
        • Royal Prince Alfred Hospital
      • Darlinghurst, New South Wales, Australia, 2010
        • Recruiting
        • St Vincent's Hospital Sydney
        • Contact:
        • Principal Investigator:
          • Dr. Anne Keogh
      • Kingswood, New South Wales, Australia, 2751
        • Recruiting
        • Nepean Hospital
        • Principal Investigator:
          • Benjamin Ng, MD
        • Contact:
      • Macquarie, New South Wales, Australia, 2109
        • Recruiting
        • Macquarie University
        • Contact:
        • Principal Investigator:
          • Martin Russel Brown
      • Sydney, New South Wales, Australia, 2145
        • Recruiting
        • Westmead Hospital
        • Contact:
        • Principal Investigator:
          • John Wheatley, PhD
    • Queensland
      • Chermside, Queensland, Australia, 4032
      • Woolloongabba, Queensland, Australia, 4102
        • Completed
        • Princess Alexandra Hospital
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
        • Recruiting
        • Royal Hobart Hospital
        • Contact:
        • Principal Investigator:
          • Nathan Dwyer, MD
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • Recruiting
        • St Vincent's Hospital Melbourne
        • Contact:
        • Principal Investigator:
          • Dr. Wendy Stevens
      • Melbourne, Victoria, Australia, 3004
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Recruiting
        • Fiona Stanley Hospital
        • Principal Investigator:
          • Melanie Anne Lavender, MD
        • Contact:
  • Austria
      • Innsbruck, Austria, 6020
        • Recruiting
        • Medizinische Universität Innsbruck
        • Principal Investigator:
          • Judith Löffler-Ragg, Prof. Dr.
        • Contact:
      • Linz, Austria, 4020
        • Recruiting
        • Ordensklinikum Linz GmbH - Elisabethinen, Fadingerstrasse 1
        • Principal Investigator:
          • Regina Steringer-Mascherbauer
        • Contact:
      • Vienna, Austria, 1090
        • Recruiting
        • AKH Wien, Innere Med. II, Kardiologie, Währingergürtel 18-20
        • Contact:
        • Principal Investigator:
          • Irene Lang
  • Belgium
      • Bruxelles, Belgium, 1070
        • Recruiting
        • Cliniques Universitaires de Bruxelles Hopital Erasme
        • Principal Investigator:
          • Prof. Jean-Luc Vachiery
        • Contact:
      • Leuven, Belgium, 3000
        • Recruiting
        • UZ Leuven, UZ Leuven Campus Gasthuisberg, Herestraat 49
        • Principal Investigator:
          • Marion Delcroix, PhD
        • Contact:
  • Brazil
    • Goias
      • Goiânia, Goias, Brazil, 74605-020
        • Recruiting
        • HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
        • Contact:
        • Principal Investigator:
          • Daniela Graner Schuwartz Tannus Silva
    • MG
      • Belo Horizonte, MG, Brazil, 30441-070
        • Recruiting
        • Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa
        • Contact:
        • Principal Investigator:
          • Frederico Thadeu Assis Figueiredo Campos
    • R.S
      • Porto Alegre, R.S, Brazil, 90610-000
        • Recruiting
        • Hospital Sao Lucas da PUC-RS
        • Contact:
        • Principal Investigator:
          • Dr. Daniela Cavalet Blanco
    • RS
      • Porto Alegre, RS, Brazil, 90035-074
        • Recruiting
        • Irmandade da Santa Casa de Misericordia de Porto Alegre
        • Principal Investigator:
          • Gisela Martina Bohns-Meyer
        • Contact:
    • SP
      • Sao Paulo, SP, Brazil, 04037-002
        • Recruiting
        • Hospital Sao Paulo
        • Contact:
        • Principal Investigator:
          • Dr. Jaquelina Sonoe Ota Arakaki
      • Sao Paulo, SP, Brazil, 05403-000
        • Recruiting
        • Instituto do Coracao
        • Principal Investigator:
          • Dr. Rogerio DeSouza
        • Contact:
    • Sao Paulo
      • Botucatu, Sao Paulo, Brazil, 18618-687
        • Recruiting
        • UNESP-Faculdade de Medicina da Universidade Estadual Paulista Campus Botucatu
        • Principal Investigator:
          • Hugo Hyung Bok Yoo
        • Contact:
  • Bulgaria
      • Sofia, Bulgaria, 1309
        • Recruiting
        • MHAT - "National Heart Hospital" EAD, 65, Konyovitza Str.
        • Principal Investigator:
          • Borislav Georgiev, MD
        • Contact:
      • Sofia, Bulgaria, 1750
        • Recruiting
        • MHAT "Sveta Anna" Sofia AD
        • Principal Investigator:
          • Vasil Velchev, Assoc. Prof.
        • Contact:
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T1Y 6J4
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • LHSC - Victoria Hospital
        • Principal Investigator:
          • Sanjay Mehta, MD
        • Contact:
      • Toronto, Ontario, Canada, M5G 2N2
        • Recruiting
        • University Health Network-Toronto General Hospital
        • Principal Investigator:
          • John Granton
        • Contact:
    • Quebec
      • Montreal, Quebec, Canada, H3T1E2
        • Completed
        • SMBD Jewish General Hospital d/b/a Jewish General Hospital
      • Québec, Quebec, Canada, G1V 4G5
        • Recruiting
        • Institut Universitaire De Cardiologie Et De Pneumologie De Québec
        • Contact:
        • Principal Investigator:
          • Steeve Provencher, MD
  • Chile
    • Santiago De Chile
      • Providencia, Santiago De Chile, Chile, 7500691
        • Recruiting
        • Instiuto Nacional del Torax
        • Principal Investigator:
          • Monica Zagolin
        • Contact:
  • China
      • Beijing, China, 100037
        • Active, not recruiting
        • Fuwai Hospital, Chinese Academy of Medical Sciences
      • Zhengzhou, China, 450000
        • Withdrawn
        • Fuwai Central China Cardiovascular Hospital
    • Beijing
      • Beijing, Beijing, China, 100038
        • Active, not recruiting
        • Beijing Shijitan Hospital, Capital Medical University
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Active, not recruiting
        • Guangdong Provincial People's Hospital
    • Hunan
      • Changsha, Hunan, China, 410008
        • Active, not recruiting
        • Xiangya Hospital Central South University
    • Shanghai
      • Shanghai, Shanghai, China, 200443
        • Active, not recruiting
        • Shanghai Pulmonary Hospital
  • Croatia
      • Zagreb, Croatia, 10000
        • Completed
        • Clinical Hospital Dubrava Zagreb, Avenija G.Šuška 6
      • Zagreb, Croatia, 10000
        • Completed
        • University Clinic for Pulmonary Diseases, Jordanovac 104
  • Czechia
      • Praha 2, Czechia, 128 08
        • Recruiting
        • Vseobecna fakultni nemocnice v Praze, II. interni klinika kardiologie a angiologie VFN a 1. LF UK, U nemocnice 2
        • Principal Investigator:
          • Pavel Jansa, MD
        • Contact:
  • Denmark
      • Copenhagen, Denmark, 2100
        • Recruiting
        • Copenhagen University Hospital (Rigshospitalet)
        • Principal Investigator:
          • Joern Carlsen
        • Contact:
      • Århus, Denmark, 8200
        • Recruiting
        • Århus Universitetshospital
        • Contact:
          • Kristine Serup-Hansen
          • Phone Number: 4521379697
          • Email: krisseru@rm.dk
        • Principal Investigator:
          • Søren Mellemkjaer, MD
  • France
      • Besançon Cedex, France, 25030
        • Recruiting
        • CHU Besançon - Hôpital Jean Minjoz
        • Contact:
        • Principal Investigator:
          • Marie-France Seronde
      • Brest cedex 2, France, 29609
        • Recruiting
        • CHU de Brest - Hôpital de la Cavale Blanche
        • Contact:
        • Principal Investigator:
          • Francis Couturaud
      • Lille Cedex, France, 59037
        • Recruiting
        • CHRU de Lille - Hopital Cardiologique
        • Contact:
        • Principal Investigator:
          • Pascal De Groote
      • Marseille, France, 13015
        • Completed
        • Hôpital Nord - CHU Marseille
    • Bas Rhin
      • Strasbourg, Bas Rhin, France, 67091
        • Recruiting
        • CHU de Strasbourg - Nouvel Hôpital Civil, Ctre de competence Hypertension Arterielle Pulmona, 1 place de l Hopital
        • Contact:
        • Principal Investigator:
          • Matthieu Canuet, MD
    • Isere
      • Grenoble, Isere, France, 38048
        • Completed
        • CHU de Grenoble - Hôpital Albert Michallon, Clinique de Cardiologie, Boulevrad de la Chantourne
    • Loire
      • Saint-Étienne, Loire, France, 42005
        • Active, not recruiting
        • 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
        • Recruiting
        • CHU Nancy - Hôpital de Brabois Adultes, Pneumologie- Oncologie Médicale, Rue du Morvan
        • Contact:
        • Principal Investigator:
          • Ari Chaouat, PhD
    • Rhone
      • Bron cedex, Rhone, France, 69677
        • Recruiting
        • CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel, Service de Pneumologie, 59 Boulevard Pinel
        • Contact:
        • Principal Investigator:
          • Prof. Vincent Cottin
    • Seine Maritime
      • Rouen cedex, Seine Maritime, France, 76031
        • Recruiting
        • CHU de Rouen - Hôpital Charles Nicolle
        • Contact:
        • Principal Investigator:
          • Fabrice Bauer
    • Val De Marne
      • Le Kremlin-Bicêtre, Val De Marne, France, 94275
        • Completed
        • Groupement Hospitalier Sud - Hôpital Bicêtre
  • Germany
      • Donaueschingen, Germany, 78166
        • Recruiting
        • Schwarzwald-Baar Klinikum
        • Contact:
        • Principal Investigator:
          • Hinrich Cordt Bremer
      • Dresden, Germany, 01307
        • Recruiting
        • Universitaetsklinikum Carl Gustav Carus TU Dresden
        • Contact:
        • Principal Investigator:
          • Michael Halank
      • Hamburg, Germany, 20246
        • Recruiting
        • Universitaetsklinikum Hamburg-Eppendorf
        • Principal Investigator:
          • Hans Klose
        • Contact:
    • Baden-Württemberg
      • Heidelberg, Baden-Württemberg, Germany, 69126
        • Recruiting
        • Thoraxklinik-Heidelberg Zentrum für Pulmonale Hypertonie
        • Principal Investigator:
          • Ekkehard Gruenig, Prof. Dr.
        • Contact:
    • Mecklenburg-Vorpommern
      • Greifswald, Mecklenburg-Vorpommern, Germany, 17475
        • Recruiting
        • Universitätsmedizin Greifswald
        • Principal Investigator:
          • Ralf Ewert, Prof. Dr.
        • Contact:
    • Rheinland Pfalz
      • Mainz, Rheinland Pfalz, Germany, 55131
        • Recruiting
        • Universitaetsmedizin der Johannes-Gutenberg-Universitaet Mainz, Zentrum für Kardiologie I, Centrum für Thrombose und Hämostase (CTH), Langenbeckstrasse 1
        • Contact:
        • Principal Investigator:
          • Kai-Helge Schmidt
    • Saarland
      • Homburg, Saarland, Germany, 66424
        • Recruiting
        • Universitaetsklinikum des Saarlandes, Innere Medizin V, IMED, Kirrberger Strasse 100, Gebäude 41
        • Contact:
        • Principal Investigator:
          • Prof. Heinrike Wilkens
    • Sachsen
      • Leipzig, Sachsen, Germany, 04103
        • Recruiting
        • Universitätsklinikum Leipzig, Medizinische Klinik II, Pneumologie
        • Principal Investigator:
          • Hubert Wirtz, Prof. Dr.
        • Contact:
  • Greece
      • Alexandroupolis, Greece, 68100
        • Completed
        • University General Hospital of Alexandroupolis
      • Chaidari, Greece, 12462
        • Completed
        • University General Hospital Attikon
      • Thessaloniki, Greece, 54636
        • Recruiting
        • AHEPA General Hospital of Thessaloniki, A' Cardiology Clinic, 1 St. Kyriakidi Street
        • Principal Investigator:
          • George Giannakoulas, PhD
        • Contact:
    • Kallithea
      • Athens, Kallithea, Greece, 17674
        • Recruiting
        • "Onasseio" Cardiosurgery Hospital, Hemodynamic Research and Interventional Cardiology Dept., 356, Syggrou Avenue
        • Contact:
        • Principal Investigator:
          • Vassilios Voudris, MD
  • Hungary
      • Budapest, Hungary, 1096
        • Recruiting
        • Gottsegen György Országos Kardiovaszkuláris Intézet
        • Contact:
        • Principal Investigator:
          • Hajnalka Olga Bálint, MD
      • Pecs, Hungary, 7624
        • Recruiting
        • Pecsi Tudomanyegyetem, Szivgyogyaszati Klinika, Ifjusag u. 13.
        • Principal Investigator:
          • Andras Komocsi, Prof. Dr.
        • Contact:
    • Csongrád-Csanád
      • Szeged, Csongrád-Csanád, Hungary, Hungary
        • Recruiting
        • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ Családorvosi Intézet és Rendelő
        • Contact:
        • Principal Investigator:
          • Albert Varga, MD
  • Israel
      • Haifa, Israel, 3436212
        • Recruiting
        • The Lady Davis Carmel Medical Center, 7 Michal st.
        • Principal Investigator:
          • Yochai Adir, MD
        • Contact:
      • Jerusalem, Israel, 9112001
        • Recruiting
        • Hadassah Ein Kerem Medical Center, Kiryat Hadassah
        • Contact:
        • Principal Investigator:
          • Neville Berkman, Prof.
      • Kfar- Sava, Israel, 4428164
        • Recruiting
        • Meir Medical Center, 59 Tshernichovski st.
        • Principal Investigator:
          • David Shitrit, MD
        • Contact:
      • Petach Tikva, Israel, 4941492
        • Recruiting
        • Rabin Medical Center-Beilinson Campus, Pulmonary Institute, 39 Jabotinsky St Ground floor
        • Contact:
        • Principal Investigator:
          • Mordechai Kramer, Prof.
      • Tel Aviv, Israel, 6423906
        • Recruiting
        • Tel Aviv Sourasky Medical Center, 6 Weizmann St.
        • Principal Investigator:
          • Amir Bar-Shai, MD
        • Contact:
  • Italy
      • Foggia, Italy, 71100
        • Completed
        • Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia, S.C. di Cardiologia, Viale Luigi Pinto, 1
      • Genova, Italy, 16132
        • Recruiting
        • IRCC Ospedale Policlinico San Martino
        • Principal Investigator:
          • Pietro Ameri, Dr.
        • Contact:
      • Milano, Italy, 20122
        • Completed
        • Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico, Via Francesco Sforza 35
      • Monza, Italy, 20900
        • Completed
        • Azienda Socio Sanitaria Territoriale Di Monza (Presidio San Gerardo)
      • Pavia, Italy, 27100
        • Recruiting
        • Fondazione IRCCS Policlinico San Matteo
        • Contact:
        • Principal Investigator:
          • Stefano Ghio
      • Roma, Italy, 00161
        • Recruiting
        • Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza, Viale del Policlinico, 155
        • Principal Investigator:
          • Roberto Badagliacca
        • Contact:
    • PA
      • Palermo, PA, Italy, 90127
        • Recruiting
        • Istituto Mediterraneo Trapianti e Terapie a Alta Specializzazione (IRCCS-ISMETT)
        • Principal Investigator:
          • Patrizio Vitulo, MD
        • Contact:
  • Korea, Republic of
    • Gangnam-gu
      • Seoul, Gangnam-gu, Korea, Republic of, 06351
        • Recruiting
        • Samsung Medical Center
        • Contact:
        • Principal Investigator:
          • Sung-A Chang
    • Jongno-gu
      • Seoul, Jongno-gu, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
        • Principal Investigator:
          • Hyung-Kwan Kim
    • Namdong-gu
      • Incheon, Namdong-gu, Korea, Republic of, 21565
        • Recruiting
        • Gachon University Hospital Gil Medical Center
        • Contact:
        • Principal Investigator:
          • Wook-Jin Chung
  • Mexico
    • Distrito Federal
      • Mexico, Distrito Federal, Mexico, 14080
        • Recruiting
        • Instituto Nacional de Cardiologia Dr Ignacio Chavez Rivera
        • Contact:
        • Principal Investigator:
          • Tomase Rene Puliod Zamudio
      • Mexico, Distrito Federal, Mexico, 14080
        • Recruiting
        • Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran
        • Contact:
          • Alejandra Lopez Spindola
          • Phone Number: 5255-5487-0900 ext 6101
          • Email: alipez@hotmail.com
        • Principal Investigator:
          • Jose Luis Hernandez Oropeza
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44160
        • Recruiting
        • CICUM San Miguel
        • Contact:
        • Principal Investigator:
          • Jorge Eduardo Rosas Cacho
    • N.l.
      • Monterrey, N.l., Mexico, 64718
        • Recruiting
        • Unidad de Investigación Clínica en Medicina, S.C.
        • Principal Investigator:
          • Carlos Jerjes Sanchez-Diaz
        • Contact:
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • Recruiting
        • VU Medisch Centrum, De Boelelaan 1117
        • Principal Investigator:
          • Prof. Antonie Vonk Noordegraaf
        • Contact:
  • Poland
      • Bialystok, Poland, 15-276
        • Recruiting
        • Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Kardiologii z Oddzialem Intensywnego Nazdoru Kardiologicznego, M. Sklodowskiej 24a
        • Contact:
        • Principal Investigator:
          • Karol Kaminski, Prof.
      • Krakow, Poland, 31-202
        • Completed
        • Krakowski Szpital Specjalistyczny im. Jana Pawla II, Oddział Kliniczny Chorób Serca i Naczyń z Pododdziałem Intensywnego Nadzoru Kardiologicznego, Pradnicka 80
      • Otwock, Poland, 05-400
        • Completed
        • NZOZ Europejskie Centrum Zdrowia, ul. Borowa 14/18
      • Poznan, Poland, 61-848
        • Recruiting
        • Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Oddzial Kardiologii - F, ul. Dluga 1/2
        • Principal Investigator:
          • Tatiana Mularek-Kubzdela
        • Contact:
      • Wroclaw, Poland, 50-414
        • Active, not recruiting
        • Premium Clinic Wrocław CM, Podwale 83/17
  • Portugal
      • Almada, Portugal, 2805-267
        • Recruiting
        • Hospital Garcia de Orta, E.P.E
        • Principal Investigator:
          • Filipa Ferreira
        • Contact:
      • Coimbra, Portugal, 3000-075
        • Recruiting
        • Centro Hospitalar e Universitário de Coimbra, E.P.E.
        • Principal Investigator:
          • Maria de Graça Castro
        • Contact:
      • Lisboa, Portugal, 1769-001
        • Recruiting
        • Centro Hospitalar Universitário Lisboa Norte, E.P.E. Hospital Pulido Valente
        • Principal Investigator:
          • Riu Plácido
        • Contact:
      • Porto, Portugal, 4099-001
        • Recruiting
        • Centro Hospitalar de Santo António E.P.E.
        • Contact:
        • Principal Investigator:
          • Fabienne Gonçalves, MD
  • Romania
      • Bucharest, Romania, 022328
        • Recruiting
        • Institutul de Urgenta pentru Boli Cardiovasculare "Prof. Dr. C.C. Iliescu", Sos. Fundeni nr. 258
        • Contact:
        • Principal Investigator:
          • Ioan Coman, MD
      • Bucuresti, Romania, 050159
        • Recruiting
        • Institutul de Pneumoftiziologie "Marius Nasta", Sos. Viilor nr. 90, Sector 5
        • Contact:
        • Principal Investigator:
          • Claudia Lucia Toma, PhD
      • Cluj-Napoca, Romania, 400001
        • Recruiting
        • Institutul Inimii "Niculae Stancioiu" Cluj-Napoca, Cardiologie, Str. Motilor nr. 19-21
        • Contact:
        • Principal Investigator:
          • Stefan Dan Cezar Mot, PhD
      • Timisoara, Romania, 300310
        • Recruiting
        • Spitalul Clinic de Boli Infectioase si Pneumoftiziologie "Dr. Victor Babes" Timisoara, Str. Gheorghe Adam nr. 13
        • Principal Investigator:
          • Dr. Voicu Mircea Tudorache
        • Contact:
  • Serbia
      • Belgrade, Serbia, 11000
        • Recruiting
        • Clinical Center of Serbia, Koste Todorovica 8
        • Principal Investigator:
          • Arsen Ristic, Prof. Dr.
        • Contact:
      • Belgrade, Serbia, 11080
        • Recruiting
        • Clinical Center Zemun. Clinic for internal medicine, Department of Cardiology
        • Contact:
        • Principal Investigator:
          • Ivan Stankovic, Assoc Prof
      • Sremska Kamenica, Serbia, 21204
        • Recruiting
        • Institute for Pulmonary Diseases of Vojvodina, Put Dr Goldmana 4
        • Principal Investigator:
          • Jovan Matijasevic
        • Contact:
  • Singapore
      • Singapore, Singapore, 119074
        • Recruiting
        • National University Hospital
        • Contact:
        • Principal Investigator:
          • Dr. Ting Ting Low
      • Singapore, Singapore, 169609
        • Recruiting
        • National Heart Centre
        • Principal Investigator:
          • Soo Teik Lim
        • Contact:
  • Spain
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clinic de Barcelona, C/ Villarroel, 170
        • Contact:
        • Principal Investigator:
          • Dr. Joan Albert Barbera Mir
      • Barcelona, Spain, 08035
        • Completed
        • Hospital Universitari Vall d'Hebron, Respiratory Dept., Passeig Vall d'Hebron,119-129, Neumologia
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de octubre
        • Principal Investigator:
          • Pilar Escribano Subias, MD
        • Contact:
      • Valencia, Spain, 46026
        • Recruiting
        • Hospoital Universitari i Politecnic La Fe
        • Contact:
        • Principal Investigator:
          • Raquel López Reyes, MD
  • Sweden
      • Göteborg, Sweden, 41345
        • Completed
        • Sahlgrenska Universitetssjukhuset
      • Linköping, Sweden, 58185
        • Completed
        • Linköping Universitetssjukhuset
      • Umeå, Sweden, 90185
        • Completed
        • Norrlands Universitetssjukhus, Hjärtcentrum
  • Taiwan
      • Tainan, Taiwan, 704
        • Recruiting
        • National Cheng Kung University Hospital
        • Contact:
        • Principal Investigator:
          • Chih-Hsin Hsu, MD
      • Taipei, Taiwan, 10002
        • Recruiting
        • National Taiwan University Hospital
        • Contact:
        • Principal Investigator:
          • Hsao-Hsun Hsu
  • Turkey
      • Ankara, Turkey, 06560
        • Recruiting
        • Gazi University Medical Faculty Hospital
        • Contact:
        • Principal Investigator:
          • Gulten Tacoy, MD
      • Bursa, Turkey, 16059
        • Recruiting
        • Uludag Universitesi Tip Fakültesi, Gorukle Kampusu
        • Contact:
        • Principal Investigator:
          • Prof. Sumeyye Gullulu
      • Istanbul, Turkey, 34899
        • Recruiting
        • Marmara Universitesi Istanbul Pendik Egitim ve Arastirma Hastanesi, Fevzi Cakmak Mahallesi Muhsin Yazicioglu Cad. No: 10
        • Contact:
        • Principal Investigator:
          • Bulent Mutlu
      • Izmir, Turkey, 35340
        • Recruiting
        • Dokuz Eylul Universitesi Tip Fakultesi, Mithatpasa caddesi Inciralti Balcova
        • Contact:
        • Principal Investigator:
          • Bahri Akdeniz
    • Odunpazari
      • Eskişehir, Odunpazari, Turkey, 26040
        • Recruiting
        • Osmangazi Uni Medical Faculty
        • Contact:
        • Principal Investigator:
          • Yuksel Cavusoglu, MD
    • Saricam
      • Adana, Saricam, Turkey, 01330
        • Recruiting
        • Balcalı, Çukurova Üniversitesi Kardiyoloji ABD
        • Contact:
        • Principal Investigator:
          • Mesut Demir, MD
    • Yenisehir
      • Mersin, Yenisehir, Turkey, 33343
        • Recruiting
        • Mersin Üniversitesi Tip Fakültesi Ciftlikköy Kampüsü
        • Contact:
        • Principal Investigator:
          • Dilek Cicek Yilmaz, MD
  • Ukraine
      • Dnipro, Ukraine, 49070
        • Recruiting
        • 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.
        • Contact:
        • Principal Investigator:
          • Larisa Vasilyeva, MD
      • Kyiv, Ukraine, 03680
        • Completed
        • SI F.H.Yanovskyi National Institute of Phthisiology and Pulmonology of NAMSU, Clinical and Functional Dept, 10, Amosova St.
      • Lviv, Ukraine, 79010
        • Completed
        • 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, SW3 6NP
        • Recruiting
        • Royal Brompton Hospital
        • Contact:
        • Principal Investigator:
          • Colm Thomas McCabe
      • London, United Kingdom, W12 0HS
        • Recruiting
        • Imperial College Healthcare NHS Trust
        • Contact:
        • Principal Investigator:
          • Luke Howard, MD
    • Greater London
      • London, Greater London, United Kingdom, NW3 2QG
        • Recruiting
        • Royal Free London NHS Foundation Trust, Pond Street
        • Contact:
        • Principal Investigator:
          • John Coghlan
    • Tyne & Wear
      • Newcastle upon Tyne, Tyne & Wear, United Kingdom, NE7 7DN
        • Recruiting
        • The Newcastle upon Tyne Hospitals NHS Foundation Trust, Sir William Leech Lung Research Centre, Freeman Hospital
        • Contact:
        • Principal Investigator:
          • Dr. James Lordan
    • West Dunbartonshire
      • Glasgow, West Dunbartonshire, United Kingdom, G81 4DY
        • Recruiting
        • Golden Jubilee National Hospital
        • Contact:
        • Principal Investigator:
          • Alistair Colin Church
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
        • Principal Investigator:
          • Jose Tallaj, MD
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Recruiting
        • St. Joseph's Hospital and Medical Center
        • Contact:
        • Principal Investigator:
          • Bhuvin Buddhdev, MD
      • Scottsdale, Arizona, United States, 85259
        • Withdrawn
        • Mayo Clinic Scottsdale
      • Tucson, Arizona, United States, 85724
        • Recruiting
        • University of Arizona
        • Contact:
        • Principal Investigator:
          • Dr. Franz Rischard
    • California
      • La Jolla, California, United States, 92037
        • Recruiting
        • UCSD Health Sciences
        • Principal Investigator:
          • Timothy Fernandes, MD
        • Contact:
      • Loma Linda, California, United States, 92354
        • Completed
        • Loma Linda University Medical Center
      • Los Angeles, California, United States, 90073
        • Recruiting
        • VA Greater Los Angeles Healthcare System
        • Contact:
        • Principal Investigator:
          • Shelley Shapiro, MD, PhD
      • Los Angeles, California, United States, 90033
        • Recruiting
        • Keck Hospital of USC
        • Contact:
        • Principal Investigator:
          • Sivagini Ganesh, MD, MPH
      • Los Angeles, California, United States, 90048
        • Completed
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90024
        • Recruiting
        • Ronald Reagan UCLA Medical Center
        • Contact:
        • Principal Investigator:
          • Rajan Saggar
      • Los Angeles, California, United States, 90027
        • Completed
        • Kaiser Permanente Los Angeles Medical Center
      • Orange, California, United States, 19103
        • Recruiting
        • University of California, Irvine
        • Principal Investigator:
          • Bassam Yaghmour, MD
        • Contact:
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California Davis Medical Center
        • Principal Investigator:
          • Namita Sood, MD
        • Contact:
      • Santa Barbara, California, United States, 93105
        • Recruiting
        • SBPA Research LLC
        • Principal Investigator:
          • Jeffrey Sager, MD
        • Contact:
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford Healthcare
        • Contact:
        • Principal Investigator:
          • Roham Zamanian, MD
      • Torrance, California, United States, 90502
        • Completed
        • LA Biomedical Research Institute Harbor-UCLA Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado Hospital
        • Principal Investigator:
          • David Badesch, MD
        • Contact:
      • Denver, Colorado, United States, 80206
        • Recruiting
        • National Jewish Health
        • Contact:
        • Principal Investigator:
          • Patricia George, MD
    • Florida
      • Gainesville, Florida, United States, 32610
        • Recruiting
        • University of Florida
        • Principal Investigator:
          • Ali Ataya, MD
        • Contact:
      • Jacksonville, Florida, United States, 32224
        • Withdrawn
        • Mayo Clinic Florida
      • Miami, Florida, United States, 33136
        • Completed
        • University of Miami
      • Orlando, Florida, United States, 32803
        • Recruiting
        • Central Florida Pulmonary Group
        • Contact:
        • Principal Investigator:
          • Daniel Layish, MD
      • Orlando, Florida, United States, 32804
        • Withdrawn
        • AdventHealth Orlando
      • Weston, Florida, United States, 33331
        • Recruiting
        • Cleveland Clinic Florida
        • Contact:
        • Principal Investigator:
          • Jinesh Mehta, MD
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital
        • Contact:
        • Principal Investigator:
          • Micah Fisher, MD
      • Austell, Georgia, United States, 30106
        • Recruiting
        • Piedmont Healthcare Pulmonary and Critical Care Research
        • Principal Investigator:
          • Chad E Miller, MD
        • Contact:
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Medical Center
        • Contact:
        • Principal Investigator:
          • Stanley Swat, MD
      • Elk Grove Village, Illinois, United States, 60007
        • Recruiting
        • Ascension Alexian Brothers
        • Contact:
        • Principal Investigator:
          • Michael Keller, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46260
        • Recruiting
        • St. Vincent Medical Group, Inc.
        • Contact:
        • Principal Investigator:
          • Ashwin Ravichandran, MD
      • Indianapolis, Indiana, United States, 46250
        • Recruiting
        • Community Health Network Cancer Center North
        • Contact:
        • Principal Investigator:
          • Sasikanth Adigopula, MD
      • Indianapolis, Indiana, United States, 46202
        • Completed
        • Indiana University School of Medicine
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • Recruiting
        • University of Iowa Hospitals and Clinics
        • Contact:
        • Principal Investigator:
          • Dr. Linda Cadaret
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Active, not recruiting
        • Kentuckiana Pulmonary Research Center
    • Louisiana
      • New Orleans, Louisiana, United States, 70121
        • Completed
        • Ochsner Medical Center
    • Maine
      • South Portland, Maine, United States, 04106
        • Completed
        • Chest Medicine Associates
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • Recruiting
        • University of Maryland Medical Center
        • Principal Investigator:
          • Gautam Ramani, MD
        • Contact:
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • Josanna Rodriguez-Lopez, MD
        • Contact:
      • Boston, Massachusetts, United States, 02111
        • Recruiting
        • Tufts Medical Center
        • Principal Investigator:
          • Ioana Preston
        • Contact:
      • Boston, Massachusetts, United States, 02118
        • Active, not recruiting
        • Boston University Medical Center
    • Michigan
      • Grand Rapids, Michigan, United States, 49546
        • Recruiting
        • Spectrum Health Medical Group
        • Principal Investigator:
          • Reda Girgis
        • Contact:
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Withdrawn
        • Mayo Clinic
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Contact:
        • Principal Investigator:
          • Murali Chakinala, MD
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Recruiting
        • Nebraska Medical Center
        • Principal Investigator:
          • Tammy Wichman, MD
        • Contact:
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
        • Recruiting
        • University of New Mexico
        • Principal Investigator:
          • Lana Melendres-Groves, MD
        • Contact:
    • New York
      • Mineola, New York, United States, 11501
        • Completed
        • Winthrop Hospital
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Medical Center
        • Contact:
        • Principal Investigator:
          • Roxana Sulica, MD
      • New York, New York, United States, 10029
        • Completed
        • Mount Sinai School of Medicine
      • New York, New York, United States, 10021
        • Completed
        • Weill-Cornell-New York Presbyterian Hospital
      • Rochester, New York, United States, 14642
        • Recruiting
        • University of Rochester
        • Contact:
        • Principal Investigator:
          • Daniel Lachant, MD
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Principal Investigator:
          • Terry Fortin, MD
        • Contact:
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • East Carolina University
        • Principal Investigator:
          • Veeranna Maddipati
        • Contact:
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • Recruiting
        • University of Cincinnati-Medical Science Building
        • Principal Investigator:
          • Jean Elwing, MD
        • Contact:
      • Cleveland, Ohio, United States, 44195
        • Completed
        • Cleveland Clinic
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Ohio State University Wexner Medical Center
        • Principal Investigator:
          • Veronica Franco, MD
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Recruiting
        • Integris Baptist Medical Center
        • Contact:
        • Principal Investigator:
          • John Kingrey, MD
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Science University
        • Contact:
        • Principal Investigator:
          • Jeffrey Robinson, MD
      • Portland, Oregon, United States, 97225
        • Active, not recruiting
        • Oregon Clinic-Pulmonary West
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
      • Philadelphia, Pennsylvania, United States, 19107
        • Recruiting
        • Thomas Jefferson University Hospital
        • Principal Investigator:
          • Michael Scharf, MD
        • Contact:
      • Philadelphia, Pennsylvania, United States, 19140
        • Completed
        • Temple University
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Allegheny General Hospital
        • Principal Investigator:
          • Amresh Raina, MD
        • Contact:
    • Tennessee
      • Knoxville, Tennessee, United States, 37919
        • Recruiting
        • Statcare Pulmonary Consultants
        • Contact:
        • Principal Investigator:
          • John Swisher, MD
    • Texas
      • Austin, Texas, United States, 78705
        • Recruiting
        • Ascension Texas Cardiovascular
        • Principal Investigator:
          • Raju Reddy, MD
        • Contact:
      • Dallas, Texas, United States, 75390
        • Recruiting
        • UT Southwestern Medical Center
        • Principal Investigator:
          • Sonja Bartolome, MD
        • Contact:
      • Houston, Texas, United States, 77030
        • Recruiting
        • Memorial Hermann Hospital
        • Contact:
        • Principal Investigator:
          • Bela Patel, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • The Methodist Hospital Research Institute
        • Contact:
        • Principal Investigator:
          • Zeenat Safdar, MD
    • Vermont
      • Colchester, Vermont, United States, 05446
        • Recruiting
        • Vermont Lung Center
        • Principal Investigator:
          • Jessica Badlam, MD
        • Contact:
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Completed
        • University of Virginia Medical Center
      • Norfolk, Virginia, United States, 23507
        • Completed
        • Sentara Cardiovascular Research Institute
      • Roanoke, Virginia, United States, 24014
        • Recruiting
        • Carilion Clinic Pulmonary and Sleep Medicine
        • Principal Investigator:
          • Sameh Aziz, MD
        • Contact:
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • Recruiting
        • Medical College of Wisconsin/Froedtert Hospital
        • Principal Investigator:
          • Kenneth W Presberg, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. At least 18 years of age.
  2. 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.
  3. Subjects who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures
  4. Primary diagnosis of symptomatic PAH.
  5. Has had a right heart catheterization (RHC) performed at or within 3 years prior to Screening (RHC will be performed during Screening if not available) that is consistent with the diagnosis of PAH.
  6. Has WHO/ NYHA functional class II to IV symptoms.
  7. If on PAH-specific background oral therapy, subject is on stable therapy with either an endothelin receptor antagonist (ERA) and/or a phosphodiesterase type 5 inhibitor (PDE5-I) or a soluble guanylate cyclase (sGC) stimulator.
  8. Has a 6MWD of ≥150 meters.
  9. If taking concomitant medications that may affect the clinical manifestations of PAH (eg, calcium channel blockers, diuretics, digoxin, or L arginine supplementation, beta blockers, angiotensin-converting enzyme inhibitors, or angiotensin II receptor blockers), must be on a stable dose for at least 30 days prior to the Baseline Visit and the dosage maintained throughout the study. The exception is that the dose of diuretics must be stable for at least the 10 days prior to Baseline.
  10. Both male and female subjects agree to use a highly effective method of birth control throughout the entire study period from informed consent through to 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 during the study and for 30 days after the last dose of IMP. Eligible male subjects must agree not to participate in sperm donation for 90 days after the last dose of IMP.

Exclusion Criteria:

  1. For subjects with known HIV-associated PAH, a cluster designation 4 (CD4+) T-cell count <200/mm3 within 90 days of Baseline.
  2. Must not have 3 or more left ventricular dysfunction risk factors as defined in the study protocol.
  3. Has evidence of more than mild lung disease on pulmonary function tests performed within 180 days prior to, or during Screening.
  4. Has evidence of thromboembolic disease as determined by a V/Q lung scan or local standard of care diagnostic evaluation at or after diagnosis of PAH.
  5. Current diagnosis of ongoing and clinically significant sleep apnea as defined by the Investigator.
  6. Male subjects with a corrected QT interval using Fridericia's formula (QTcF) >450 msec and female subjects with a QTcF >470 msec on ECG recorded at Screening and analyzed by the central ECG laboratory. Subjects with evidence of intraventricular conduction delay, defined as a QRS interval greater than 110 msec, will be excluded if the QTcF is >500 msec for both males and females.
  7. Severe chronic liver disease (ie, Child-Pugh Class C), portal hypertension, cirrhosis or complications of cirrhosis/portal hypertension (eg, history of variceal hemorrhage, encephalopathy).
  8. Confirmed active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
  9. Subjects with alanine aminotransferase or aspartate aminotransferase ≥3 times the upper limit of normal (ULN) or total bilirubin ≥2 × ULN at Screening.
  10. Chronic renal insufficiency as defined by serum creatinine >2.5 mg/dL or requiring dialysis at Screening.
  11. Hemoglobin concentration <9 g/dL at Screening.
  12. Subjects treated with an IV or SC prostacyclin pathway agent (eg, epoprostenol, treprostinil, or iloprost) for PAH at any time prior to Baseline (use in vasoreactive testing is permitted).
  13. Subjects currently on or who were treated with an inhaled or oral prostacyclin pathway agent (iloprost, treprostinil, beraprost, or selexipag) for >6 months or within 90 days prior to Baseline.
  14. Subject has pulmonary veno-occlusive disease.
  15. Malignancy diagnosed and/or treated within 5 years prior to Screening, with the exception of localized non-metastatic basal cell or squamous cell carcinoma of the skin or in-situ carcinoma of the cervix excised with curative intent.
  16. Subject tests positive for amphetamine, cocaine, methamphetamine, methylenedioxymethamphetamine or phencyclidine in urine drug screen performed at Screening, or has a recent history (6 months) of alcohol or drug abuse. A subject will not be excluded due to a positive drug screen caused by prescribed medications.
  17. Initiation or discontinuation of a cardio-pulmonary rehabilitation program based upon exercise within 90 days prior to Screening and/or planned during study participation.
  18. Prior participation in any study of ralinepag or participation in another interventional clinical study with medicinal products within 30 days prior to Screening. Concurrent participation in registry or observational studies is allowed, as long as the subject can fulfill all other entry criteria and comply with all study procedures.
  19. Any reason that, in the opinion of the Investigator or Medical Monitor, precludes the subject from participating in the study (eg, any previous or intercurrent medical condition) that may increase the risk associated with study participation or that would confound study analysis or impair study participation or cooperation.
  20. Known hypersensitivity to ralinepag or any of the excipients.
  21. Life expectancy <12 months based on the Investigator's opinion.
  22. Women who are pregnant, lactating or breast-feeding.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

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
Placebo Comparator: Placebo
Matching placebo tablets (oral)
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time from randomization to the first adjudicated protocol-defined clinical worsening event
Time Frame: The study duration was event-based. This parameter was assessed from randomization until the conclusion of the study, up to 3 years
Clinical worsening events are defined as death, nonelective hospital admission for worsening PAH (further defined in clinical study protocol), initiation of parenteral or inhaled prostacyclin pathway agent for treatment of worsening PAH, disease progression (further defined in clinical study protocol), or unsatisfactory long-term clinical response (further defined in clinical study protocol).
The study duration was event-based. This parameter was assessed from randomization until the conclusion of the study, up to 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in N-terminal pro-brain natriuretic peptide (NT-proBNP)
Time Frame: Baseline to Week 28
NT-proBNP was measured at Baseline (prior to starting study drug) and Week 4, 8, 12, and 16, then every 12 weeks thereafter including the End of Study/Early Termination Visit.
Baseline to Week 28
Change from Baseline in 6-minute walk distance (6MWD)
Time Frame: Baseline to Week 28
6MWD was measured at Baseline (prior to starting study drug) and Week 4, 8, 12, and 16, then every 12 weeks thereafter including the End of Study/Early Termination Visit.
Baseline to Week 28
Change from Baseline in WHO/New York Heart Association (NYHA) Functional Class
Time Frame: Baseline to Week 28
The severity of PAH was graded according to the functional status of the subject and assessed at every visit.
Baseline to Week 28
Shift and proportion of subjects who attain all 3 of the following: NT-proBNP level <300 pg/mL, 6MWD >440 meters, and WHO/NYHA Functional Class I or II
Time Frame: Baseline to Week 28
Data from NT-proBNP, 6MWD, and WHO/NYHA functional class assessment were compiled as a composite endpoint at visits through Week 28.
Baseline to Week 28
Registry to Evaluate Early and Long-term PAH Disease Management (REVEAL) risk score
Time Frame: Baseline to Week 28
Data from NT-proBNP, 6MWD, WHO/NYHA functional class, systolic blood pressure, heart rate, and estimated glomerular filtration rate values collected at visits through Week 28 were used to calculate the composite REVEAL risk score.
Baseline to Week 28
Clinical improvement as defined by the absence of clinical worsening and fulfillment of at least 2 of the 3 of the following: increase in 6MWD ≥10% or ≥30 m, improvement to or maintenance of WHO FC I or II, and decrease in NT-proBNP by at least 30%.
Time Frame: Baseline to Week 28
Data from 6MWD, WHO/NYHA functional class assessment, and NT-proBNP were compiled as a composite endpoint at visits through Week 28.
Baseline to Week 28
Change from Baseline in health-related quality of life as measured by patient-reported outcomes.
Time Frame: Baseline to Week 28
Quality of life was assessed using patient-reported outcomes at Baseline (prior to starting study drug) and Week 16, then every 12 weeks thereafter including the End of Study/Early Termination Visit.
Baseline to Week 28
Time to first all-cause nonelective hospitalization
Time Frame: The study duration was event-based. This parameter was assessed from randomization until the conclusion of the study (when the target number of adjudicated events was achieved, as defined in the study protocol).
All nonelective hopsitalizations during the study period were collected.
The study duration was event-based. This parameter was assessed from randomization until the conclusion of the study (when the target number of adjudicated events was achieved, as defined in the study protocol).
Time to all-cause mortality
Time Frame: The study duration was event-based. This parameter was assessed from randomization until the conclusion of the study (when the target number of adjudicated events was achieved, as defined in the study protocol).
All deaths during the study period were collected.
The study duration was event-based. This parameter was assessed from randomization until the conclusion of the study (when the target number of adjudicated events was achieved, as defined in the study protocol).
Change from Baseline in heart rate recovery (HRR) following completion of the 6MWT
Time Frame: Baseline to Week 28
HRR was measured at Baseline (prior to starting study drug) and Week 4, 8, 12, and 16, then every 12 weeks thereafter including the End of Study/Early Termination Visit.
Baseline to Week 28
Safety and tolerability of ralinepag in subjects with PAH
Time Frame: Baseline to Week 28
Safety and tolerability were assessed by adverse events.
Baseline to Week 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

United Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 30, 2018

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

July 27, 2018

First Submitted That Met QC Criteria

August 9, 2018

First Posted (Actual)

August 13, 2018

Study Record Updates

Last Update Posted (Actual)

April 18, 2024

Last Update Submitted That Met QC Criteria

April 17, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ROR-PH-301
  • APD811-301 (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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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