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AzTrials

PAHPhase 3NCT03683186

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

A Phase 3 study testing Ralinepag in people with PAH and Pulmonary Hypertension, run by United Therapeutics at 190 sites in 33 countries.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Ralinepag
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,000 participants
Where
190 sitesin 33 countries
Study dates
23 Sep 2019to Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

190 sites in 33 countries. Contact the study team or a site near you to ask about taking part.

190 sites in 33 countries

United States48 sites

  • University of New Mexico

    Albuquerque, New Mexico, 87131

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • University of Colorado Hospital

    Aurora, Colorado, 80045

  • Piedmont Healthcare Pulmonary and Critical Care Research

    Austell, Georgia, 30106

  • Ascension Texas Cardiovascular

    Austin, Texas, 78705

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Boston University Medical Center

    Boston, Massachusetts, 02118

  • Vermont Lung Center

    Burlington, Vermont, 05446

  • University of Chicago Medical Center

    Chicago, Illinois, 60637

  • University of Cincinnati-Medical Science Building

    Cincinnati, Ohio, 45267

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • National Jewish Health

    Denver, Colorado, 80206

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Ascension Alexian Brothers

    Elk Grove Village, Illinois, 60007

  • University of Florida

    Gainesville, Florida, 32610

  • Spectrum Health Medical Group

    Grand Rapids, Michigan, 49546

  • East Carolina University

    Greenville, North Carolina, 27834

  • Memorial Hermann Hospital

    Houston, Texas, 77030

  • The Methodist Hospital Research Institute

    Houston, Texas, 77030

  • Community Heart and Vascular Hospital

    Indianapolis, Indiana, 46256

  • St. Vincent Medical Group, Inc.

    Indianapolis, Indiana, 46260

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • StatCare Pulmonary Consultants

    Knoxville, Tennessee, 37919

  • UCSD Health Sciences

    La Jolla, California, 92037

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90024

  • Keck Hospital of USC

    Los Angeles, California, 90033

  • VA Greater Los Angeles Healthcare System

    Los Angeles, California, 90073

  • Medical College of Wisconsin/Froedtert Hospital

    Milwaukee, Wisconsin, 53226

  • NYU Langone Medical Center

    New York, New York, 10016

  • Integris Baptist Medical Center

    Oklahoma City, Oklahoma, 73112

  • University of California, Irvine

    Orange, California, 92868

  • Central Florida Pulmonary Group

    Orlando, Florida, 32803

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • St. Joseph's Hospital and Medical Center-Norton Thoracic Institute

    Phoenix, Arizona, 85013

  • Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Oregon Health & Science University

    Portland, Oregon, 97239

  • Carilion Clinic Pulmonary and Sleep Medicine

    Roanoke, Virginia, 24014

  • University of Rochester

    Rochester, New York, 14642

  • University of California Davis Medical Center

    Sacramento, California, 95817

  • Santa Barbara Cottage Hospital

    Santa Barbara, California, 93105

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stanford University Medical Center

    Stanford, California, 94305

  • University of Arizona

    Tucson, Arizona, 85724

  • Cleveland Clinic Florida

    Weston, Florida, 33331

Other trials in United States

Argentina12 sites

  • Sanatorio de la Trinidad Mitre

    Buenos Aires

  • Cardiologia Palmero

    Caba, 1425

  • Hospital Britanico de Buenos Aires

    Ciudad Autonoma Buenos Aires, 1280

  • Fundacion Respirar

    Ciudad Autonoma Buenos Aires, 1426

  • Fundacion Favaloro

    Ciudad Autonoma Buenos Aires, C1093AAS

  • Hospital Italiano

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1181ACH

  • Hospital Italiano de Cordoba

    Córdoba, X5004BAL

  • Hospital Privado Centro Medico de Cordoba S.A

    Córdoba, X5016KEH

  • Instituto de Cardiologia de Corrientes

    Corrientes

  • Instituto de Investigaciones Clinicas

    Mar del Plata

  • Sanatorio Parque

    Rosario, Santa Fe Province, 2000

  • Hospital PROVINCIAL "Dr. Jose Maria Cullen"

    Santa Fe, Santa Fe de La Vera Cruz, 3000

Other trials in Argentina

Australia11 sites

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • The Prince Charles Hospital

    Chermside, Queensland, 4032

  • St Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Royal Hobart Hospital

    Hobart, Tasmania, 7000

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Fiona Stanley Hospital

    Perth, Western Australia, 6150

  • Macquarie University

    Sydney, New South Wales, 2109

  • Westmead Hospital

    Sydney, New South Wales, 2145

  • Nepean Hospital

    Sydney, New South Wales, 2751

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

France11 sites

  • CHU Besançon - Hôpital Jean Minjoz

    Besançon, 25030

  • CHU de Brest - Hôpital de la Cavale Blanche

    Brest, 29609

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

    Bron, Rhone, 69677

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

    Grenoble, Isere, 38048

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

    Le Kremlin-Bicêtre, Val De Marne, 94275

  • CHRU de Lille - Hopital Cardiologique

    Lille, 59037

  • Hôpital Nord - CHU Marseille

    Marseille, 13015

  • CHU de Rouen - Hôpital Charles Nicolle

    Rouen, Seine Maritime, 76031

  • 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

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

    Strasbourg, Bas Rhin, 67091

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

    Vandœuvre-lès-Nancy, Meurthe Et Moselle, 54511

Other trials in France

Germany8 sites

  • Schwarzwald-Baar Klinikum

    Donaueschingen, 78166

  • Universitaetsklinikum Carl Gustav Carus TU Dresden

    Dresden, 01307

  • Universitätsmedizin Greifswald

    Greifswald, Mecklenburg-Vorpommern, 17475

  • Universitaetsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • Thoraxklinik-Heidelberg Zentrum für Pulmonale Hypertonie

    Heidelberg, Baden-Wurttemberg, 69126

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

    Homburg, Saarland, 66424

  • Universitätsklinikum Leipzig, Medizinische Klinik II, Pneumologie

    Leipzig, Saxony, 04103

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

    Mainz, Rhineland-Palatinate, 55131

Other trials in Germany

Italy8 sites

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

    Foggia, 71100

  • IRCC Ospedale Policlinico San Martino

    Genova, 16132

  • Centro Cardiologico Monzino, IRCCS U.O. Scompenso

    Milan, 20138

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

    Milan, 20122

  • Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)

    Monza, 20900

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

    Palermo, PA, 90127

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

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

    Roma, 00161

Other trials in Italy

Brazil7 sites

  • Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa

    Belo Horizonte, Minas Gerais, 30441-070

  • UNESP-Faculdade de Medicina da Universidade Estadual Paulista Campus Botucatu

    Botucatu, São Paulo, 18618-687

  • HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás

    Goiânia, Goiás, 74605-020

  • Hospital Sao Lucas da PUC-RS

    Porto Alegre, R.S, 90610-000

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90035-074

  • Hospital Sao Paulo

    São Paulo, São Paulo, 04037-002

  • Instituto do Coracao

    São Paulo, São Paulo, 05403-000

Other trials in Brazil

Turkey (Türkiye)7 sites

  • Balcalı, Çukurova Üniversitesi Kardiyoloji ABD

    Adana, Saricam, 01330

  • Gazi University Medical Faculty Hospital

    Ankara, 06560

  • Uludag Universitesi Tip Fakültesi, Gorukle Kampusu

    Bursa, 16059

  • Osmangazi Uni Medical Faculty

    Eskişehir, Odumpazari, 26480

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

    Istanbul, 34899

  • Dokuz Eylul Universitesi Tip Fakultesi, Mithatpasa caddesi Inciralti Balcova

    Izmir, 35340

  • Mersin Üniversitesi Tip Fakültesi Ciftlikköy Kampüsü

    Mersin, Yenisehir, 33343

Other trials in Turkey (Türkiye)

Canada6 sites

  • Peter Lougheed Centre

    Calgary, Alberta, T1Y 6J4

  • University of Alberta Hospital

    Edmonton, Alberta, T6G 2B7

  • LHSC - Victoria Hospital

    London, Ontario, N6A 5W9

  • SMBD Jewish General Hospital d/b/a Jewish General Hospital

    Montreal, Quebec, H3T1E2

  • Institut Universitaire de Cardiologie et de Pneumologie de Quebec

    Québec, Quebec

  • University Health Network-Toronto General Hospital

    Toronto, Ontario, M5G 2N2

Other trials in Canada

China5 sites

  • Beijing Shijitan Hospital, Capital Medical University

    Beijing, Beijing Municipality, 100038

  • Fuwai Hospital, Chinese Academy of Medical Sciences

    Beijing, 100037

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080

  • Shanghai Pulmonary Hospital

    Shanghai, Shanghai Municipality, 200443

Other trials in China

Israel5 sites

  • The Lady Davis Carmel Medical Center, 7 Michal st.

    Haifa, 3436212

  • Hadassah Ein Kerem Medical Center, Kiryat Hadassah

    Jerusalem, 9112001

  • Meir Medical Center, 59 Tshernichovski st.

    Kfar Saba, 4428164

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

    Petah Tikva, 4941492

  • Tel Aviv Sourasky Medical Center, 6 Weizmann St.

    Tel Aviv, 6423906

Other trials in Israel

Poland5 sites

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

    Bialystok, 15-276

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

    Krakow, 31-202

  • NZOZ Europejskie Centrum Zdrowia, ul. Borowa 14/18

    Otwock, 05-400

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

    Poznan, 61-848

  • Premium Clinic Wrocław CM, Podwale 83/17

    Wroclaw, 50-414

Other trials in Poland

United Kingdom5 sites

  • Golden Jubilee National Hospital

    Glasgow, West Dunbartonshire, G81 4DY

  • Royal Free London NHS Foundation Trust, Pond Street

    London, Greater London, NW3 2QG

  • Royal Brompton Hospital

    London, Greater London, SW3 6NP

  • Hammersmith Hospital

    London, W12 0HS

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

    Newcastle upon Tyne, Tyne and Wear, NE7 7DN

Other trials in United Kingdom

Greece4 sites

  • University General Hospital of Alexandroupolis

    Alexandroupoli, 68100

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

    Athens, 17674

  • University General Hospital Attikon

    Chaïdári, 12462

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

    Thessaloniki, 54636

Other trials in Greece

Mexico4 sites

  • CICUM San Miguel

    Guadalajara, Jalisco, 44160

  • Instituto Nacional de Cardiologia Dr Ignacio Chavez Rivera

    Mexico City, Mexico City, 14080

  • Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran

    Mexico City, Mexico City, 14080

  • Unidad de Investigacion Clinica en Medicina, S.C.

    Monterrey, N.L., 64718

Other trials in Mexico

Portugal4 sites

  • Hospital Garcia de Orta, E.P.E

    Almada, 2805-267

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

    Coimbra, 3000-075

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

    Lisbon, 1769-001

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

    Porto, 4099-001

Other trials in Portugal

Romania4 sites

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

    Bucharest, 022328

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

    Bucharest, 050159

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

    Cluj-Napoca, 400001

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

    Timișoara, 300310

Other trials in Romania

Spain4 sites

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

    Barcelona, 08035

  • Hospital Clinic de Barcelona, C/ Villarroel, 170

    Barcelona, 08036

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

Austria3 sites

  • Medizinische Universität Innsbruck

    Innsbruck, A-6020

  • Ordensklinikum Linz GmbH - Elisabethinen, Fadingerstrasse 1

    Linz, 4020

  • AKH Wien, Innere Med. II, Kardiologie, Währingergürtel 18-20

    Vienna, 1090

Other trials in Austria

Serbia3 sites

  • Clinical Center of Serbia, Koste Todorovica 8

    Belgrade, 11000

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

    Belgrade, 11080

  • Institute for Pulmonary Diseases of Vojvodina, Put Dr Goldmana 4

    Kamenitz, 21204

Other trials in Serbia

South Korea3 sites

  • Gachon University Hospital Gil Medical Center

    Incheon, Namdong-gu, 21565

  • Samsung Medical Center

    Seoul, Gangnam-gu, 06351

  • Seoul National University Hospital

    Seoul, Jongno-gu, 03080

Other trials in South Korea

Sweden3 sites

  • Sahlgrenska Universitetssjukhuset

    Gothenburg, 41345

  • Linköping Universitetssjukhuset

    Linköping, 58185

  • Norrlands Universitetssjukhus, Hjärtcentrum

    Umeå, 90185

Other trials in Sweden

Ukraine3 sites

  • 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

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

    Kyiv, 03680

  • 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

Other trials in Ukraine

Belgium2 sites

  • Cliniques Universitaires de Bruxelles Hopital Erasme

    Brussels, 1070

  • UZ Leuven, UZ Leuven Campus Gasthuisberg, Herestraat 49

    Leuven, 3000

Other trials in Belgium

Bulgaria2 sites

  • MHAT - "National Heart Hospital" EAD, 65, Konyovitza Str.

    Sofia, 1309

  • MHAT "Sveta Anna" Sofia AD

    Sofia, 1750

Other trials in Bulgaria

Croatia2 sites

  • Clinical Hospital Dubrava Zagreb, Avenija G.Šuška 6

    Zagreb, 10000

  • University Clinic for Pulmonary Diseases, Jordanovac 104

    Zagreb, 10000

Other trials in Croatia

Denmark2 sites

  • Århus Universitetshospital

    Aarhus, 8200

  • Copenhagen University Hospital (Rigshospitalet)

    Copenhagen, 2100

Other trials in Denmark

Hungary2 sites

  • Gottsegen György Országos Kardiovaszkuláris Intézet

    Budapest, 1096

  • Pecsi Tudomanyegyetem, Szivgyogyaszati Klinika, Ifjusag u. 13.

    Pécs, 7624

Other trials in Hungary

Singapore2 sites

  • National University Hospital

    Singapore, 119074

  • National Heart Centre

    Singapore, 169609

Other trials in Singapore

Taiwan2 sites

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 10002

Other trials in Taiwan

Chile1 site

  • Instiuto Nacional del Torax

    Providencia, Santiago de Chile, 7500691

Other trials in Chile

Czechia1 site

  • Vseobecna fakultni nemocnice v Praze, II. interni klinika kardiologie a angiologie VFN a 1. LF UK, U nemocnice 2

    Prague, 128 08

Other trials in Czechia

Netherlands1 site

  • VU Medisch Centrum, De Boelelaan 1117

    Amsterdam, 1081 HV

Other trials in Netherlands

About this study

Official title: A Phase 3 Open-label Extension (OLE) Study to Evaluate the Long-term Safety and Efficacy of Ralinepag in Subjects With World Health Organization (WHO) Group 1 Pulmonary Arterial Hypertension (PAH)

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.

Read the 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.

Being tested
Ralinepag
Keywords
Prostacyclin, Connective Tissue Disease-Associated, 6 Minute Walk Test, 6 Minute Walk Distance, Pulmonary Vascular Resistance, Right Ventricular Function
Medical subject headings
Hypertension, Pulmonary, Pulmonary Arterial Hypertension, Hypertension, Connective Tissue Diseases, Familial Primary Pulmonary Hypertension, Vascular Diseases, Cardiovascular Diseases, Lung Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RalinepagDrug

    Also called APD811

    Active

Study groups in NCT03683186
Study groupRoleWhat they receive
RalinepagExperimentalRalinepag once daily extended-release tablets (oral) 50, 250, and 400 mcg titrated to the highest tolerated dose.
Receives: Drug: Ralinepag

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Up to 6 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2018
  2. Study start23 Sep 2019
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03683186
Sponsor's protocol ID
ROR-PH-303
Other IDs
APD811-303
Status last verified
Oct 2026
First submitted
19 Sep 2018
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ralinepag in people with PAH and Pulmonary Hypertension, run by United Therapeutics at 190 sites in 33 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 190 sites in United States, Argentina, Australia, France, Germany and 28 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of subjects with treatment-emergent adverse events [Safety and Tolerability] (time frame: Up to 6 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03683186.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.

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