A Study Evaluating the Efficacy and Safety of Ralinepag to Improve Treatment Outcomes in PAH Patients
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
2 other identifiers
interventional
687
31 countries
203
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Aug 2018
Longer than P75 for phase_3
203 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 27, 2018
CompletedFirst Posted
Study publicly available on registry
August 13, 2018
CompletedStudy Start
First participant enrolled
August 30, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedApril 14, 2026
April 1, 2026
7.3 years
July 27, 2018
April 13, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time from randomization to the first adjudicated protocol-defined clinical worsening event
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 Outcomes (11)
Change from Baseline in N-terminal pro-brain natriuretic peptide (NT-proBNP)
Baseline to Week 28
Change from Baseline in 6-minute walk distance (6MWD)
Baseline to Week 28
Change from Baseline in WHO/New York Heart Association (NYHA) Functional Class
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
Baseline to Week 28
Registry to Evaluate Early and Long-term PAH Disease Management (REVEAL) risk score
Baseline to Week 28
- +6 more secondary outcomes
Study Arms (2)
Ralinepag
EXPERIMENTALRalinepag once daily extended-release tablets (oral) 50, 250, and 400 mcg titrated to the highest tolerated dose.
Placebo
PLACEBO COMPARATORMatching placebo tablets (oral)
Interventions
Eligibility Criteria
You may qualify if:
- At least 18 years of age.
- 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
- Primary diagnosis of symptomatic PAH.
- 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.
- Has WHO/ NYHA functional class II to IV symptoms.
- 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.
- Has a 6MWD of ≥150 meters.
- 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.
- 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.
You may not qualify if:
- For subjects with known HIV-associated PAH, a cluster designation 4 (CD4+) T-cell count \<200/mm3 within 90 days of Baseline.
- Must not have 3 or more left ventricular dysfunction risk factors as defined in the study protocol.
- Has evidence of more than mild lung disease on pulmonary function tests performed within 180 days prior to, or during Screening.
- 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.
- Current diagnosis of ongoing and clinically significant sleep apnea as defined by the Investigator.
- 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.
- Severe chronic liver disease (ie, Child-Pugh Class C), portal hypertension, cirrhosis or complications of cirrhosis/portal hypertension (eg, history of variceal hemorrhage, encephalopathy).
- Confirmed active infection with hepatitis B virus (HBV) or hepatitis C virus (HCV).
- Subjects with alanine aminotransferase or aspartate aminotransferase ≥3 times the upper limit of normal (ULN) or total bilirubin ≥2 × ULN at Screening.
- Chronic renal insufficiency as defined by serum creatinine \>2.5 mg/dL or requiring dialysis at Screening.
- Hemoglobin concentration \<9 g/dL at Screening.
- Subjects treated with an IV or SC prostacyclin pathway agent (eg, epoprostenol, treprostinil, or iloprost) or activin signaling inhibitor for PAH at any time prior to Baseline (use in vasoreactive testing is permitted).
- 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.
- Subject has pulmonary veno-occlusive disease.
- 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.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (209)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
St. Joseph's Hospital and Medical Center
Phoenix, Arizona, 85013, United States
University of Arizona
Tucson, Arizona, 85724, United States
UCSD Health Sciences
La Jolla, California, 92037, United States
Loma Linda University Medical Center
Loma Linda, California, 92354, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, 90024, United States
Kaiser Permanente Los Angeles Medical Center
Los Angeles, California, 90027, United States
Keck Hospital of USC
Los Angeles, California, 90033, United States
Cedars-Sinai Medical Center
Los Angeles, California, 90048, United States
VA Greater Los Angeles Healthcare System
Los Angeles, California, 90073, United States
University of California, Irvine
Orange, California, 19103, United States
University of California Davis Medical Center
Sacramento, California, 95817, United States
SBPA Research LLC
Santa Barbara, California, 93105, United States
Stanford Healthcare
Stanford, California, 94305, United States
LA Biomedical Research Institute Harbor-UCLA Medical Center
Torrance, California, 90502, United States
University of Colorado Hospital
Aurora, Colorado, 80045, United States
National Jewish Health
Denver, Colorado, 80206, United States
University of Florida
Gainesville, Florida, 32610, United States
University of Miami
Miami, Florida, 33136, United States
Central Florida Pulmonary Group
Orlando, Florida, 32803, United States
Cleveland Clinic Florida
Weston, Florida, 33331, United States
Emory University Hospital
Atlanta, Georgia, 30322, United States
Piedmont Healthcare Pulmonary and Critical Care Research
Austell, Georgia, 30106, United States
University of Chicago Medical Center
Chicago, Illinois, 60637, United States
Ascension Alexian Brothers
Elk Grove Village, Illinois, 60007, United States
Indiana University School of Medicine
Indianapolis, Indiana, 46202, United States
Community Health Network Cancer Center North
Indianapolis, Indiana, 46250, United States
St. Vincent Medical Group, Inc.
Indianapolis, Indiana, 46260, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Kentuckiana Pulmonary Research Center
Louisville, Kentucky, 40202, United States
Ochsner Medical Center
New Orleans, Louisiana, 70121, United States
Chest Medicine Associates
South Portland, Maine, 04106, United States
University of Maryland Medical Center
Baltimore, Maryland, 21201, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
Boston University Medical Center
Boston, Massachusetts, 02118, United States
Spectrum Health Medical Group
Grand Rapids, Michigan, 49546, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Nebraska Medical Center
Omaha, Nebraska, 68198, United States
University of New Mexico
Albuquerque, New Mexico, 87131, United States
Winthrop Hospital
Mineola, New York, 11501, United States
NYU Langone Medical Center
New York, New York, 10016, United States
Weill-Cornell-New York Presbyterian Hospital
New York, New York, 10021, United States
Mount Sinai School of Medicine
New York, New York, 10029, United States
University of Rochester
Rochester, New York, 14642, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
East Carolina University
Greenville, North Carolina, 27834, United States
University of Cincinnati-Medical Science Building
Cincinnati, Ohio, 45267, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
Integris Baptist Medical Center
Oklahoma City, Oklahoma, 73112, United States
Oregon Clinic-Pulmonary West
Portland, Oregon, 97225, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, 19107, United States
Temple University
Philadelphia, Pennsylvania, 19140, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
Statcare Pulmonary Consultants
Knoxville, Tennessee, 37919, United States
Ascension Texas Cardiovascular
Austin, Texas, 78705, United States
Baylor University Medical Center
Dallas, Texas, 75246, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Memorial Hermann Hospital
Houston, Texas, 77030, United States
The Methodist Hospital Research Institute
Houston, Texas, 77030, United States
Vermont Lung Center
Colchester, Vermont, 05446, United States
University of Virginia Medical Center
Charlottesville, Virginia, 22908, United States
Sentara Cardiovascular Research Institute
Norfolk, Virginia, 23507, United States
Carilion Clinic Pulmonary and Sleep Medicine
Roanoke, Virginia, 24014, United States
Medical College of Wisconsin/Froedtert Hospital
Milwaukee, Wisconsin, 53226, United States
Hospital Italiano
Ciudad Autonoma Buenos Aires, Buenos Aires, C1181ACH, Argentina
Instituto de Investigaciones Clinicas Mar del Plata
Mar del Plata, Buenos Aires, 7600, Argentina
Sanatorio Parque
Rosario, Santa Fe Province, 2000, Argentina
Sanatorio de la Trinidad Mitre
Buenos Aires, C1039AAO, Argentina
Cardiologia Palmero
Caba, 1425, Argentina
Hospital Britanico de Buenos Aires
Ciudad Autonoma Buenos Aires, 1280, Argentina
Fundacion Respirar
Ciudad Autonoma Buenos Aires, 1426, Argentina
Fundacion Favaloro
Ciudad Autonoma Buenos Aires, C1093AAS, Argentina
Instituto de Cardiologia de Corrientes
Corrientes, Argentina
Hospital Italiano de Cordoba
Córdoba, X5004BAL, Argentina
Hospital Privado Centro Medico de Cordoba S.A
Córdoba, X5016KEH, Argentina
Hospital PROVINCIAL "Dr. Jose Maria Cullen"
Santa Fe, 3000, Argentina
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050, Australia
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010, Australia
Nepean Hospital
Kingswood, New South Wales, 2751, Australia
Macquarie University
Macquarie, New South Wales, 2109, Australia
Westmead Hospital
Sydney, New South Wales, 2145, Australia
The Prince Charles Hospital
Chermside, Queensland, 4032, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102, Australia
Royal Hobart Hospital
Hobart, Tasmania, 7000, Australia
St Vincent's Hospital Melbourne
Fitzroy, Victoria, 3065, Australia
The Alfred Hospital
Melbourne, Victoria, 3004, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Medizinische Universität Innsbruck
Innsbruck, 6020, Austria
Ordensklinikum Linz GmbH - Elisabethinen, Fadingerstrasse 1
Linz, 4020, Austria
AKH Wien, Innere Med. II, Kardiologie, Währingergürtel 18-20
Vienna, 1090, Austria
Cliniques Universitaires de Bruxelles Hopital Erasme
Brussels, 1070, Belgium
UZ Leuven, UZ Leuven Campus Gasthuisberg, Herestraat 49
Leuven, 3000, Belgium
HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
Goiânia, Goiás, 74605-020, Brazil
Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa
Belo Horizonte, Minas Gerais, 30441-070, Brazil
Hospital Sao Lucas da PUC-RS
Porto Alegre, R.S, 90610-000, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-074, Brazil
UNESP-Faculdade de Medicina da Universidade Estadual Paulista Campus Botucatu
Botucatu, São Paulo, 18618-687, Brazil
Hospital Sao Paulo
São Paulo, São Paulo, 04037-002, Brazil
Instituto do Coracao
São Paulo, São Paulo, 05403-000, Brazil
MHAT - "National Heart Hospital" EAD, 65, Konyovitza Str.
Sofia, 1309, Bulgaria
MHAT "Sveta Anna" Sofia AD
Sofia, 1750, Bulgaria
Peter Lougheed Centre
Calgary, Alberta, T1Y 6J4, Canada
LHSC - Victoria Hospital
London, Ontario, N6A 5W9, Canada
University Health Network-Toronto General Hospital
Toronto, Ontario, M5G 2N2, Canada
SMBD Jewish General Hospital d/b/a Jewish General Hospital
Montreal, Quebec, H3T1E2, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Québec, Quebec, G1V 4G5, Canada
Instiuto Nacional del Torax
Providencia, Santiago de Chile, 7500691, Chile
Beijing Shijitan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100038, China
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, 510080, China
Xiangya Hospital Central South University
Changsha, Hunan, 410008, China
Shanghai Pulmonary Hospital
Shanghai, Shanghai Municipality, 200443, China
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, 100037, China
Clinical Hospital Dubrava Zagreb, Avenija G.Šuška 6
Zagreb, 10000, Croatia
University Clinic for Pulmonary Diseases, Jordanovac 104
Zagreb, 10000, Croatia
Vseobecna fakultni nemocnice v Praze, II. interni klinika kardiologie a angiologie VFN a 1. LF UK, U nemocnice 2
Prague, 128 08, Czechia
Århus Universitetshospital
Aarhus, 8200, Denmark
Copenhagen University Hospital (Rigshospitalet)
Copenhagen, 2100, Denmark
CHU de Strasbourg - Nouvel Hôpital Civil, Ctre de competence Hypertension Arterielle Pulmona, 1 place de l Hopital
Strasbourg, Bas Rhin, 67091, France
CHU de Grenoble - Hôpital Albert Michallon, Clinique de Cardiologie, Boulevrad de la Chantourne
Grenoble, Isere, 38048, France
CHU Nancy - Hôpital de Brabois Adultes, Pneumologie- Oncologie Médicale, Rue du Morvan
Vandœuvre-lès-Nancy, Meurthe Et Moselle, 54511, France
CHU de Saint-Etienne - Hopital Nord, Service de Medecine vasculaire et therapeutique, 81 Avenue A. Raimond
Saint-Étienne-de-Montluc, Pays de la Loire Region, 42005, France
CHU Lyon - Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel, Service de Pneumologie, 59 Boulevard Pinel
Bron, Rhone, 69677, France
CHU de Rouen - Hôpital Charles Nicolle
Rouen, Seine Maritime, 76031, France
Groupement Hospitalier Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre, Val De Marne, 94275, France
CHU Besançon - Hôpital Jean Minjoz
Besançon, 25030, France
CHU de Brest - Hôpital de la Cavale Blanche
Brest, 29609, France
CHRU de Lille - Hopital Cardiologique
Lille, 59037, France
Hôpital Nord - CHU Marseille
Marseille, 13015, France
Thoraxklinik-Heidelberg Zentrum für Pulmonale Hypertonie
Heidelberg, Baden-Wurttemberg, 69126, Germany
Universitätsmedizin Greifswald
Greifswald, Mecklenburg-Vorpommern, 17475, Germany
Universitaetsmedizin der Johannes-Gutenberg-Universitaet Mainz, Zentrum für Kardiologie I, Centrum für Thrombose und Hämostase (CTH), Langenbeckstrasse 1
Mainz, Rhineland-Palatinate, 55131, Germany
Universitaetsklinikum des Saarlandes, Innere Medizin V, IMED, Kirrberger Strasse 100, Gebäude 41
Homburg, Saarland, 66424, Germany
Universitätsklinikum Leipzig, Medizinische Klinik II, Pneumologie
Leipzig, Saxony, 04103, Germany
Schwarzwald-Baar Klinikum
Donaueschingen, 78166, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden, 01307, Germany
Universitaetsklinikum Hamburg-Eppendorf
Hamburg, 20246, Germany
"Onasseio" Cardiosurgery Hospital, Hemodynamic Research and Interventional Cardiology Dept., 356, Syggrou Avenue
Athens, Kallithea, 17674, Greece
University General Hospital of Alexandroupolis
Alexandroupoli, 68100, Greece
University General Hospital Attikon
Chaïdári, 12462, Greece
AHEPA General Hospital of Thessaloniki, A' Cardiology Clinic, 1 St. Kyriakidi Street
Thessaloniki, 54636, Greece
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ Családorvosi Intézet és Rendelő
Szeged, Csongrád-Csanád, Hungary, Hungary
Gottsegen György Országos Kardiovaszkuláris Intézet
Budapest, 1096, Hungary
Pecsi Tudomanyegyetem, Szivgyogyaszati Klinika, Ifjusag u. 13.
Pécs, 7624, Hungary
The Lady Davis Carmel Medical Center, 7 Michal st.
Haifa, 3436212, Israel
Hadassah Ein Kerem Medical Center, Kiryat Hadassah
Jerusalem, 9112001, Israel
Meir Medical Center, 59 Tshernichovski st.
Kfar Saba, 4428164, Israel
Rabin Medical Center-Beilinson Campus, Pulmonary Institute, 39 Jabotinsky St Ground floor
Petah Tikva, 4941492, Israel
Tel Aviv Sourasky Medical Center, 6 Weizmann St.
Tel Aviv, 6423906, Israel
Istituto Mediterraneo Trapianti e Terapie a Alta Specializzazione (IRCCS-ISMETT)
Palermo, PA, 90127, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia, S.C. di Cardiologia, Viale Luigi Pinto, 1
Foggia, 71100, Italy
IRCC Ospedale Policlinico San Martino
Genova, 16132, Italy
Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico, Via Francesco Sforza 35
Milan, 20122, Italy
Azienda Socio Sanitaria Territoriale di Monza (Presidio San Gerardo)
Monza, 20900, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100, Italy
Azienda Ospedaliera Universitaria Policlinico Umberto I - Università di Roma La Sapienza, Viale del Policlinico, 155
Roma, 00161, Italy
CICUM San Miguel
Guadalajara, Jalisco, 44160, Mexico
Instituto Nacional de Cardiologia Dr Ignacio Chavez Rivera
Mexico City, Mexico City, 14080, Mexico
Instituto Nacional de Ciencias Médicas y Nutricion Dr. Salvador Zubiran
Mexico City, Mexico City, 14080, Mexico
Unidad de Investigacion Clinica en Medicina, S.C.
Monterrey, N.L., 64718, Mexico
VU Medisch Centrum, De Boelelaan 1117
Amsterdam, 1081 HV, Netherlands
Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Kardiologii z Oddzialem Intensywnego Nazdoru Kardiologicznego, M. Sklodowskiej 24a
Bialystok, 15-276, Poland
Krakowski Szpital Specjalistyczny im. Jana Pawla II, Oddział Kliniczny Chorób Serca i Naczyń z Pododdziałem Intensywnego Nadzoru Kardiologicznego, Pradnicka 80
Krakow, 31-202, Poland
NZOZ Europejskie Centrum Zdrowia, ul. Borowa 14/18
Otwock, 05-400, Poland
Szpital Kliniczny Przemienienia Panskiego Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Oddzial Kardiologii - F, ul. Dluga 1/2
Poznan, 61-848, Poland
Premium Clinic Wrocław CM, Podwale 83/17
Wroclaw, 50-414, Poland
Hospital Garcia de Orta, E.P.E
Almada, 2805-267, Portugal
Centro Hospitalar e Universitário de Coimbra, E.P.E.
Coimbra, 3000-075, Portugal
Centro Hospitalar Universitário Lisboa Norte, E.P.E. Hospital Pulido Valente
Lisbon, 1769-001, Portugal
Centro Hospitalar de Santo António E.P.E.
Porto, 4099-001, Portugal
Institutul de Urgenta pentru Boli Cardiovasculare "Prof. Dr. C.C. Iliescu", Sos. Fundeni nr. 258
Bucharest, 022328, Romania
Institutul de Pneumoftiziologie "Marius Nasta", Sos. Viilor nr. 90, Sector 5
Bucharest, 050159, Romania
Institutul Inimii "Niculae Stancioiu" Cluj-Napoca, Cardiologie, Str. Motilor nr. 19-21
Cluj-Napoca, 400001, Romania
Spitalul Clinic de Boli Infectioase si Pneumoftiziologie "Dr. Victor Babes" Timisoara, Str. Gheorghe Adam nr. 13
Timișoara, 300310, Romania
Clinical Center of Serbia, Koste Todorovica 8
Belgrade, 11000, Serbia
Clinical Center Zemun. Clinic for internal medicine, Department of Cardiology
Belgrade, 11080, Serbia
Institute for Pulmonary Diseases of Vojvodina, Put Dr Goldmana 4
Kamenitz, 21204, Serbia
National University Hospital
Singapore, 119074, Singapore
National Heart Centre
Singapore, 169609, Singapore
Samsung Medical Center
Seoul, Gangnam-gu, 06351, South Korea
Seoul National University Hospital
Seoul, Jongno-gu, 03080, South Korea
Gachon University Hospital Gil Medical Center
Incheon, Namdong-gu, 21565, South Korea
Hospital Universitari Vall d'Hebron, Respiratory Dept., Passeig Vall d'Hebron,119-129, Neumologia
Barcelona, 08035, Spain
Hospital Clinic de Barcelona, C/ Villarroel, 170
Barcelona, 08036, Spain
Hospital Universitario 12 de Octubre
Madrid, 28041, Spain
Hospoital Universitari i Politecnic La Fe
Valencia, 46026, Spain
Sahlgrenska Universitetssjukhuset
Gothenburg, 41345, Sweden
Linköping Universitetssjukhuset
Linköping, 58185, Sweden
Norrlands Universitetssjukhus, Hjärtcentrum
Umeå, 90185, Sweden
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Osmangazi Uni Medical Faculty
Eskişehir, Odunpazari, 26040, Turkey (Türkiye)
Balcalı, Çukurova Üniversitesi Kardiyoloji ABD
Adana, Saricam, 01330, Turkey (Türkiye)
Mersin Üniversitesi Tip Fakültesi Ciftlikköy Kampüsü
Mersin, Yenisehir, 33343, Turkey (Türkiye)
Gazi University Medical Faculty Hospital
Ankara, 06560, Turkey (Türkiye)
Uludag Universitesi Tip Fakültesi, Gorukle Kampusu
Bursa, 16059, Turkey (Türkiye)
Marmara Universitesi Istanbul Pendik Egitim ve Arastirma Hastanesi
Istanbul, 34899, Turkey (Türkiye)
Dokuz Eylul Universitesi Tip Fakultesi, Mithatpasa caddesi Inciralti Balcova
Izmir, 35340, Turkey (Türkiye)
CE Dniprop RCC&C Center of Dniprop RC Dept of Card SI DMA of MOHU, Chair of Internal Medicine 3, 28, Knyazya Volodymyra Velykogo St.
Dnipro, 49070, Ukraine
SI F.H.Yanovskyi National Institute of Phthisiology and Pulmonology of NAMSU, Clinical and Functional Dept, 10, Amosova St.
Kyiv, 03680, Ukraine
Communal Noncommercial Enterprise of Lviv Regional Council Lviv Clinical Hospital, Dept of Cardiology, D.Halytskyi Lviv NMU, Ch of Internal Medicine #1, 7, Chernihivska str.
Lviv, 79010, Ukraine
Royal Free London NHS Foundation Trust, Pond Street
London, Greater London, NW3 2QG, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust, Sir William Leech Lung Research Centre
Newcastle upon Tyne, Tyne and Wear, NE7 7DN, United Kingdom
Golden Jubilee National Hospital
Glasgow, West Dunbartonshire, G81 4DY, United Kingdom
Royal Brompton Hospital
London, SW3 6NP, United Kingdom
Imperial College Healthcare NHS Trust
London, W12 0HS, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 27, 2018
First Posted
August 13, 2018
Study Start
August 30, 2018
Primary Completion
December 31, 2025
Study Completion
December 31, 2025
Last Updated
April 14, 2026
Record last verified: 2026-04