Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension
UNISUS
A Phase 3, Prospective, Multicenter, Double-blind, Double-dummy, Randomized, Active-controlled, Parallel-group, Group-sequential, Adaptive, Event-driven Study to Compare Efficacy, Safety, and Tolerability of Macitentan 75 mg Versus Macitentan 10 mg in Patients With Pulmonary Arterial Hypertension, Followed by an Open-label Treatment Period With Macitentan 75 mg
4 other identifiers
interventional
935
39 countries
263
Brief Summary
The purpose of this study is to demonstrate superiority of macitentan 75 milligrams (mg) in prolonging the time to the first clinical events committee (CEC)-adjudicated morbidity or mortality (M/M) event in participants with symptomatic pulmonary arterial hypertension (PAH) compared to macitentan 10 mg.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2020
Longer than P75 for phase_3
263 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
January 31, 2020
CompletedFirst Posted
Study publicly available on registry
February 18, 2020
CompletedStudy Start
First participant enrolled
June 30, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 7, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2029
ExpectedApril 13, 2026
April 1, 2026
5.3 years
January 31, 2020
April 9, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Double-blind Treatment Period: Time to First Clinical Events Committee (CEC)-adjudicated Morbidity or Mortality (M/M) Events
Time to first CEC-adjudicated M/M event on-treatment (ie.,up to 7 days after last dose of DB study intervention) is defined as time from randomization to first of following events: All-cause death, including death caused by on-treatment adverse event that occur within 4 weeks of study DB treatment discontinuation;non-planned Pulmonary Arterial Hypertension(PAH)-related hospitalization(including for worsening of PAH, atrial septostomy, lung transplantation with or without heart transplantation, or initiation of parenteral prostacyclins);PAH-related disease progression, defined as worsening of World Health Organization(WHO) Functional Class(FC) from baseline or deterioration by at least 15% in exercise capacity, as measured by 6-minute walk distance(6MWD), from baseline and confirmed by second 6MWD test performed on different day within 2 week of initial test or appearance or worsening of signs or symptoms of right-sided heart failure that require initiation of intravenous diuretics.
Up to 4 years
Secondary Outcomes (6)
Double-blind Treatment Period: Change From Baseline to Week 24 in 6MWD
Baseline up to Week 24
Double-blind Treatment Period: Number of Participants with CEC-adjudicated Death due to PAH and/or Hospitalizations for PAH (First and Recurrent) Events on-treatment
Up to 4 years
Double-blind Treatment Period: Change From Baseline to Week 24 in PAH Symptoms Based on PAH-SYMPACT Questionnaire- Cardiopulmonary Symptom Domain Score
Baseline up to Week 24
Double-blind Treatment Period: Change From Baseline to Week 24 in PAH Symptoms Based on PAH-SYMPACT Questionnaire- Cardiovascular Symptom Domain Score
Baseline up to Week 24
Double-blind Treatment Period: Time to Death Occurring Between Randomization and End of Double-blind Treatment (EDBT)
Up to 4 years
- +1 more secondary outcomes
Study Arms (2)
Macitentan 10 milligrams (mg) + Placebo
ACTIVE COMPARATORRun-in period:Participants who are either endothelin receptor antagonist (ERA)-naïve or who are receiving daily dose of macitentan or ambrisentan less (\<) 10 milligrams (mg), or daily dose of bosentan \<250 mg, will enter 4-week open-label run-in period with macitentan 10 mg prior to randomization. ERA-pre-treated participants will bypass run-in period and will be randomized to either macitentan 75 mg or macitentan 10 mg directly.Double-blind Treatment (DBT) Period:Participants will receive macitentan 10 mg orally up to End of DBT.To maintain blind, participants will receive macitentan 37.5 mg-matching placebo for 4 weeks and macitentan 75 mg-matching placebo thereafter up to DBT.Treatment Extension Period:After EDBT, participants will receive macitentan 37.5 mg once a day (qd) orally for 4 weeks, prior to receiving open-label macitentan 75 mg qd orally for 2 years. To maintain blind, participants will receive macitentan 75 mg-matching placebo during 4-week uptitration.
Macitentan 75 mg + Placebo
EXPERIMENTALRun-in period:Participants who are either ERA-naive or who are receiving a daily dose of macitentan or ambrisentan \<10 mg, or a daily dose of bosentan \<250 mg, will enter 4-week open-label run-in period with macitentan 10 mg prior to randomization. ERA-pre-treated patients will bypass the run-in period and will be randomized to either macitentan 75 mg or macitentan 10 mg directly.DBT Period: participants will receive macitentan 37.5 mg orally for 4 weeks and macitentan 75 mg thereafter up to End of DBT. To maintain the blind, participants will receive macitentan 10 mg-matching placebo up to End of DBT.Treatment Extension Period: After EDBT, participants will continue to receive macitentan 75 mg orally for 2 years. To maintain the blind, participants will receive macitentan 37.5 mg-matching placebo during the 4-week up-titration period.
Interventions
Participants will receive macitentan 10 mg film-coated tablets orally.
Participants will receive macitentan 37.5 mg film-coated tablets orally.
Participants will receive macitentan 75 mg film-coated tablets orally.
Participants will receive matching placebo film-coated tablets orally.
Eligibility Criteria
You may qualify if:
- Target population: greater than or equal to (\>=) 18 (or the legal age of consent in the jurisdiction in which the study is taking place) years of age
- Target population: Symptomatic Pulmonary Arterial Hypertension (PAH) in World Health Organization Functional Class (WHO FC) II, III, or IV
- Target population: PAH subtype falling in one of the below classifications: Idiopathic; Heritable; Drug- or toxin-induced; Related to: Connective tissue disease, HIV infection, Portal hypertension, and Congenital heart disease with small/coincidental cardiac defect with systemic-to-pulmonary shunt (for example atrial septal defect, ventricular septal defect, patent ductus arteriosus, atrioventricular septal defect) which does not account for the elevated pulmonary vascular resistance (PVR) or persistent PAH documented by an Right heart catheterization (RHC) \>= 1 year after simple systemic-to pulmonary shunt repair
- PAH diagnosis confirmed by hemodynamic evaluation at rest at any time prior to screening: Mean pulmonary artery pressure (mPAP) greater than (\>) 20 millimeters of mercury (mm Hg), and; Pulmonary artery wedge pressure (PAWP) or left ventricular end diastolic pressure (LVEDP) less than or equal to (\<=) 15 mm Hg, and PVR \>= 3 Wood Units (that is, \>= 240 dyn\*sec/cm\^5)
- Able to perform the 6-minute walking test (6MWT) with a minimum distance of 50 meters (m) and maximum distance of 440m at screening. Participants able to walk more than 440m at screening are eligible if they are in WHO FC III or IV and n-terminal prohormone of brain natriuretic peptide or n-terminal pro B-type natriuretic peptide (NT-proBNP) level is \>=300 nanograms per liter (ng/L) at screening, based on central laboratory results
You may not qualify if:
- Known presence of three or more of the following risk factors for heart failure with preserved ejection fraction at screening, based on records that confirm documented medical history: Body mass index (BMI) \> 30 kilograms per meter square (kg/m\^2), Diabetes mellitus of any type, Essential hypertension (even if well controlled); Coronary artery disease, that is, any of the following: history of stable angina, or known more than 50 percent (%) stenosis in a coronary artery, or history of myocardial infarction, or history of or planned coronary artery bypass grafting and/or coronary artery stenting
- Presence of moderate or severe obstructive lung disease (forced expiratory volume in 1 second \[FEV1\] / forced vital capacity \[FVC\] \< 70%; and FEV1 \< 60% of predicted after bronchodilator administration) ) in participants with a known or suspected history of significant lung disease as documented by a spirometry test performed within 1 year prior to screening
- Known moderate to severe hepatic impairment, defined as Child-Pugh Class B or C, based on records that confirm documented medical history
- Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 1.5\*upper limit of normal (ULN) at screening
- Hemoglobin \< 100 gram per liter (g/L) (\< 10 gram per deciliter \[g/dL\]) at screening
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Actelionlead
Study Sites (274)
Mayo Clinic
Phoenix, Arizona, 85054, United States
Arizona Pulmonary Specialists, Ltd
Scottsdale, Arizona, 85258, United States
Scripps Memorial Hospital
La Jolla, California, 92037, United States
USC Keck
Los Angeles, California, 90033, United States
Jeffrey S. Sager, MD Medical Corporation
Santa Barbara, California, 93105, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
Torrance, California, 90502-2006, United States
National Jewish Health
Denver, Colorado, 80206, United States
Cleveland Clinic
Weston, Florida, 33331 3609, United States
Piedmont Healthcare
Atlanta, Georgia, 30309, United States
Northside Hospital
Atlanta, Georgia, 30342, United States
Advocate Christ Medical Center
Oak Lawn, Illinois, 60453, United States
Indiana University
Indianapolis, Indiana, 46202, United States
St. Vincent Medical Group, Inc.
Indianapolis, Indiana, 46260, United States
University Of Iowa - Hospitals & Clinics
Iowa City, Iowa, 52242, United States
Norton Pulmonary Specialists
Louisville, Kentucky, 40202, United States
Louisiana State University
New Orleans, Louisiana, 70112 7021, United States
University of Michigan
Ann Arbor, Michigan, 48109-5000, United States
Troy Beaumont
Troy, Michigan, 53215, United States
Washington University School Of Medicine
St Louis, Missouri, 63110-1032, United States
Saint Louis University Academic Pavillion
St Louis, Missouri, 63110, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198-2265, United States
Reno Heart Institute
Reno, Nevada, 89511, United States
Winthrop University Hospital
Mineola, New York, 11501, United States
Mount Sinai
New York, New York, 10029, United States
Columbia University
New York, New York, 10032, United States
Stony Brook University Medical Center
Stony Brook, New York, 11794, United States
Duke
Durham, North Carolina, 27710-4000, United States
Lindner Clinical Trial Center/Christ Hospital
Cincinnati, Ohio, 45219, United States
Integris Baptist Office
Oklahoma City, Oklahoma, 73112, United States
The Oregon Clinic
Portland, Oregon, 97220-9442, United States
Oregon Pulmonary Clinic
Portland, Oregon, 97225-6652, United States
Oregon Health And Science University
Portland, Oregon, 97239-3011, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104-5545, United States
Allegheny General Hospital of Research
Pittsburgh, Pennsylvania, 15212, United States
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096, United States
AnMed Health
Anderson, South Carolina, 29621, United States
UT Southwestern Medical Center
Dallas, Texas, 75390, United States
Baylor College of Medicine (BCM) - Baylor Heart Clinic
Houston, Texas, 77030, United States
Baylor Scott White - Plano
Plano, Texas, 75093, United States
San Antonio Methodist TX Transplant Physicians Group
San Antonio, Texas, 78229-3771, United States
The Robert Larner, M.D. College of Medicine at The University of Vermont
Burlington, Vermont, 05405, United States
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, 53792, United States
Medical College Of Wisconsin
Milwaukee, Wisconsin, 53226, United States
Sanatorio de la Trinidad Mitre
Buenos Aires, C1039AAO, Argentina
Sanatorio Guemes
C.a.b.a., C1180AAX, Argentina
Hospital Italiano de Buenos Aires
Caba, 1199ABB, Argentina
Sanatorio Ramon Cereijo
Caba, C1048AAN, Argentina
Centro Médico Dra. De Salvo
Caba, C1426ABP, Argentina
Instituto de Cardiologia de Corrientes
Corrientes, W3400AMZ, Argentina
Instituto Medico de La Fundacion Estudios Clinicos
Rosario, 2000, Argentina
Instituto Cardiovascular de Rosario
Rosario, S2000DSR, Argentina
Flinders Medical Centre
Bedford Park, 5042, Australia
Royal Prince Alfred Hospital
Camperdown, 2050, Australia
The Prince Charles Hospital
Chermside, 4032, Australia
St Vincent's hospital
Darlinghurst, 2010, Australia
Royal Hobart Hospital
Hobart, 7000, Australia
Fiona Stanley Hospital
Murdoch, 6150, Australia
Westmead Hospital
Westmead, 2145, Australia
LKH-Univ. Klinikum Graz
Graz, 8036, Austria
Ordensklinikum Linz GmbH Elisabethinen
Linz, 4020, Austria
Medical University Vienna
Vienna, 1090, Austria
The Republican Scientific-Practical Center ''Cardiology''
Minsk, 220036, Belarus
Minsk Regional Clinical Hospital
Minsk, 220143, Belarus
ULB Hôpital Erasme
Brussels, 1070, Belgium
UZ Leuven
Leuven, 3000, Belgium
Universidade Federal De Minas Gerais - Hospital das Clínicas
Belo Horizonte, 30130-100, Brazil
Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa
Belo Horizonte, 30441-070, Brazil
Empresa Brasileira de Servicos Hospitalares-EBSERH-Hospital Universitario de Brasilia
Brasília, 70840-901, Brazil
Sociedade Hospitalar Angelina Caron - Hospital Angelina Caron
Campina Grande do Sul, 83430-000, Brazil
Ceti - Centro de Estudos Em Terapias Inovadoras
Curitiba, 80060-240, Brazil
Ynova Pesquisa Clinica
Florianópolis, 88020-210, Brazil
Universidade Federal de Goias - Hospital das Clinicas da UFG
Goiânia, 74605-020, Brazil
Hospital das Clinicas de Porto Alegre
Porto Alegre, 90035-003, Brazil
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
Porto Alegre, 90610-000, Brazil
Instituto de Medicina Integral Professor Fernando Figueira
Recife, 50070-902, Brazil
Fundacao do ABC Centro Universitario FMABC
Santo André, 09060 870, Brazil
Secretaria de Estado da Saude Instituto Dante Pazzanese de Cardiologia
São Paulo, 04012-909, Brazil
Hospital Das Clinicas Da Faculdade De Medicina Da USP
São Paulo, 05403-000, Brazil
Multiprofile Hospital For Active Treatment National Cardiology Hospital, Ead
Sofia, 1309, Bulgaria
University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD
Sofia, 1750, Bulgaria
St. Joseph's Health Centre
Hamilton, Ontario, L8N 4A6, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7, Canada
University Health Network - Toronto General Hospital
Toronto, Ontario, M5G2C4, Canada
Jewish General Hospital
Montreal, Quebec, H3T 1E2, Canada
Beijing Chaoyang Hospital
Beijing, 100020, China
Beijing Anzhen Hospital
Beijing, 100029, China
Peking Union Medical College Hospital
Beijing, 100730, China
The Second Xiangya Hospital of Central South Hospital
Changsha, 410011, China
West China Hospital Sichuan University
Chengdu, 610041, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, 400016, China
The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, 510120, China
Shanghai Pulmonary Hospital
Shanghai, 200433, China
Renji Hospital
Shanghai, 201112, China
Zhongshan Hospital Fudan University
Shanghai, China
The General Hospital of Northern Theater Command
Shenyang, 110000, China
Shengjing Hospital Of China Medical University
Shenyang, 110004, China
Tianjin Medical University General Hospital
Tianjin, 300052, China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, 710061, China
Fundacion Neumologica Colombiana
Bogotá, 1101131, Colombia
Fundacion Cardiovascular de Colombia
Bucaramanga - Piedecuesta - Valle de Menzuli, 6810002, Colombia
Clínica Imbanaco S.A.S.
Cali, 760042, Colombia
Centro Cardiovascular Colombiano Clínica Santa María
Medellín, 681004, Colombia
Hospital Universidad del Norte
Soledad, 0000000, Colombia
General University Hospital II.department of Internal Medicine-cardiology and angiology
Prague, 128 08, Czechia
Århus Universitetshospital, Skejby, Hjertemedicinsk Afdeling B
Aarhus, 8200, Denmark
CHU de Brest - Hopital de la Cavale Blanche
Brest, 29200, France
Hôpital Côte de Nacre
Caen, France
Hopital Bicetre Aphp Hopitaux Universitaires Paris Sud
Le Kremlin-Bicêtre, 94270, France
CHRU de Lille Hopital Claude Huriez
Lille, France
Aphm - Hopital Nord
Marseille, 13915, France
Centre Hospitalier Universitaire - de Nice - Hopital Pasteur
Nice, 06002, France
CHU Saint Etienne Hopital Nord
Saint-Priest-en-Jarez, 42277, France
Hopital Larrey CHU de Toulouse
Toulouse, France
Ruhr Universitat Bochum Diabeteszentrum
Bad Oeynhausen, 32545, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Medizinische Klinik und Poliklinik V Klinikum Grosshadern der LMU
München, 81377, Germany
Universitaetsklinikum Regensburg
Regensburg, 93053, Germany
University Hospital of Alexandroupolis
Alexandroupoli, 681 00, Greece
Alexandra General Hospital of Athens
Athens, 11528, Greece
University Hospital Of Larissa
Larissa, 41334, Greece
Ahepa University General Hospital of Thessaloniki
Thessaloniki, 54636, Greece
Semmelweis Egyetem,Pulmonológiai Klinika
Budapest, 1083, Hungary
Gottsegen Gyorgy Orszagos Kardiovaszkularis Intezet Felnott kardiologiai osztaly
Budapest, 1096, Hungary
Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar
Pécs, 7624, Hungary
Szegedi Tudományegyetem, Általános Orvostudományi Kar, Családorvosi Intézet és rendelő
Szeged, 6720, Hungary
NHL Medical College (SVP Hospital IMSR)
Ahmedabad, 380006, India
Cims Hospital
Ahmedabad, 381060, India
Narayana Hrudayalaya Limited
Bangalore, 560099, India
SRM Medical College Hospital & Research Centre
Chengalpetu, 603203, India
Govindaswamy Kuppuswamy Naidu Memorial Hospital
Coimbatore, 64103, India
HealthWorld Hospitals
Durgapur, 713216, India
Renova Century Hospitals
Hyderabad, 500034, India
Care Hospitals
Hyderbad, 500034, India
Rabindranath Tagore International Institute of Cardiac Sciences
Kolkata, 700099, India
GB Pant Institute of Post Graduate Medical Education & Research
New Delhi, 110002, India
Sir Ganga Ram Hospital
New Delhi, 110060, India
Jawaharlal Institute of Postgraduate Medical Education and Research
Puducherry, 605008, India
B.D. Mehta Mahavir Heart Institute
Surat, 395001, India
Carmel Medical Center
Haifa, 34362, Israel
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
Kaplan Medical Center
Rehovot, 76100, Israel
The Chaim Sheba Medical Center
Tel Litwinsky, 5265601, Israel
Yitzhak Shamir Medical Center
Ẕerifin, 70300, Israel
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162, Italy
AOU Di Modena Policlinico Di Modena
Modena, 41125, Italy
Ospedale San Francesco
Nuoro, 08100, Italy
Fondazione IRCCS Policlinico San Matteo
Pavia, 27100, Italy
Fondazione Toscana Gabriele Monasterio CNR
Pisa, 56124, Italy
Policlinico Gemelli Universita Cattolica
Roma, 00168, Italy
The University of Tokyo Hospital
Bunkyō City, 113-8655, Japan
Kyushu University Hospital
Fukuoka, 812 8582, Japan
Kure Kyosai Hospital
Hiroshima, 737-8505, Japan
Kagoshima University Hospital
Kagoshima, 890 8520, Japan
St Marianna University Hospital
Kanagawa, 216 8511, Japan
Kanazawa University Hospital
Kanazawa, 920 8641, Japan
Kobe University Hospital
Kobe, 650 0017, Japan
Kurume University Hospital
Kurume, 830-0011, Japan
University Hospital Kyoto Prefectural University of Medicine
Kyoto, 602-8566, Japan
Kyoto University Hospital
Kyoto, 606 8507, Japan
Shinshu University Hospital
Matsumoto, 390 8621, Japan
Nagasaki University Hospital
Nagasaki, 852-8501, Japan
Nagoya University Hospital
Nagoya, 466 8560, Japan
Nagoya City University Hospital
Nagoya, 467 8602, Japan
Niigata University Medical And Dental Hospital
Niigata, 951 8520, Japan
Okayama University Hospital
Okayama, 700 8558, Japan
National Hospital Organization Okayama Medical Center
Okayama, 701-1192, Japan
Sapporo Medical University Hospital
Sapporo, 060 8543, Japan
Hokkaido University Hospital
Sapporo, 060-8648, Japan
National Cerebral and Cardiovascular Center
Suita-Shi, 564-8565, Japan
Juntendo University Hospital
Tokyo, 113-8431, Japan
Fujita Health University Hospital
Toyoake, 470-1192, Japan
University of Tsukuba Hospital
Tsukuba, 305 8576, Japan
Hospital Pulau Pinang
George Town, 10990, Malaysia
Hospital Serdang
Kajang, 43000, Malaysia
Sarawak Heart Center
Kota Samarahan, 94300, Malaysia
Institut Jantung Negara (National Heart Institute)
Kuala Lumpur, 50400, Malaysia
Consultorio Privado del Dr. Gabriel Arturo Ramos Lopez
Guadalajara, 44657, Mexico
Instituto Nacional de Cardiologia Dr. Ignacio Chavez
Mexico City, 14080, Mexico
Operadora de Hospitales Angeles SA de CV Hospital Angeles Lomas
México, 52787, Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, 64460, Mexico
Unidad de Investigacion Clinica en Medicina S.C. (UDICEM)
Monterrey, 64718, Mexico
Centro de Investigacion Clinica Chapultepec
Morelia, 58260, Mexico
VUMC Amsterdam
Amsterdam, 1081 HV, Netherlands
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein, 3435 CM, Netherlands
Radboud Umcn
Nijmegen, 6525 GA, Netherlands
Erasmus MC
Rotterdam, 3015 CN, Netherlands
Akershus Universitetssykehus
Nordbyhagen, 1478, Norway
Oslo University Hospital
Oslo, 372, Norway
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, 15 276, Poland
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy, Klinika Kardiologii
Bydgoszcz, 85-168, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, 80214, Poland
SPSK nr 7 SUM w Katowicach Gornoslaskie Centrum Medyczne im Prof Leszka Gieca
Katowice, 40 635, Poland
Krakowski Szpital Specjalityczny im Jana Pawla II Oddzial Kliniczny Chorob Serca i Naczyn
Krakow, 31 202, Poland
Uniwersytecki Szpital Kliniczny nr 2 PUM w Szczecinie
Szczecin, 70 111, Poland
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
Warsaw, 02 507, Poland
Wojewodzki Szpital Specjalistyczny we Wroclawiu Osrodek Badawczo Rozwojowy
Wroclaw, 51 124, Poland
Uls Coimbra - Hosp. Univ. Coimbra
Coimbra, 3004 561, Portugal
Uls Sao Jose - Hosp. Santa Marta
Lisbon, 1169-024, Portugal
Uls Santa Maria - Hosp. Pulido Valente
Lisbon, 1769-001, Portugal
Altay Regional Cardiological Dispensary
Barnaul, 656055, Russia
Chelyabinsk Regional Clinical Hospital
Chelyabinsk, 454076, Russia
State Autonomous HealthCare Institution 'Interregional Clinical Diagnostic Center'
Kazan', 420101, Russia
Scientific and Research Institution of Cardiovascular Diseases Complex Problems
Kemerovo, 650002, Russia
Moscow City Clinical Hospital No.51
Moscow, 121309, Russia
National Medical Research Center of Cardiology of MoH of Russian Federation
Moscow, 121552, Russia
National medical Research Center n.a. V.A.Almazov of MoH of Russian Federation
Saint Petersburg, 197341, Russia
Samara Regional Clinical Cardiological Dispensary
Samara, 443070, Russia
State Autonomous Healthcare Institution of Tyumen Region 'Scientific and Practical Medical Center'
Tyumen, 625032, Russia
Volgograd Regional Clinical Cardiology Center
Volgograd, 400008, Russia
King Faisal Specialist Hospital & Research Center
Riyadh, 11564, Saudi Arabia
King Fahad Medical City
Riyadh, 59046, Saudi Arabia
University Clinical Center of Serbia
Belgrade, 11000, Serbia
Institute for Pulmonary Disease of Vojvodina
Kamenitz, 21204, Serbia
National University Heart Centre, Singapore
Singapore, 119228, Singapore
National Heart Centre (NHC) Singapore
Singapore, 169609, Singapore
Narodny ustav srdcovych a cievnych chorob
Bratislava, 833 48, Slovakia
The Eastern Slovakia Institute of Cardiovascular Diseases
Košice, 040 11, Slovakia
Milpark Hospital
Johannesburg, South Africa
Dr Kalla
Lenasia, 1820, South Africa
Severance Hospital Yonsei University Health System
Seoul, 03722, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Seoul National University Hospital
Seoul, 3080, South Korea
Hosp Univ Vall D Hebron
Barcelona, 08035, Spain
Hosp. Del Mar
Barcelona, 8003, Spain
Hosp. Univ. 12 de Octubre
Madrid, 28041, Spain
Hosp. Univ. La Paz
Madrid, 28046, Spain
Hosp. Univ. Pta. de Hierro Majadahonda
Madrid, 28222, Spain
Hosp. Costa Del Sol
Málaga, 29603, Spain
Hosp Clinico Univ de Salamanca
Salamanca, 37007, Spain
Sahlgrenska Universitetsjukhuset
Gothenburg, 413 45, Sweden
Skanes universitetssjukhus
Lund, 221 85, Sweden
National Cheng Kung University Hospital
Tainan, 704, Taiwan
National Taiwan University Hospital
Taipei, 10002, Taiwan
Mackay Memorial Hospital
Taipei, 10449, Taiwan
Taipei Veterans General Hospital
Taipei, 112, Taiwan
Phramongkutklao Hospital and Medical College
Bangkok, 10400, Thailand
Ramathibodi Hospital Mahidol University
Bangkok, 10400, Thailand
Siriraj Hospital Mahidol University
Bangkok, 10700, Thailand
Maharaj Nakorn Chiang Mai hospital Faculty of Medicine
Chiang Mai, 50020, Thailand
Srinagarind Hospital, Khon Kaen University
Khon Kaen, 40002, Thailand
Songklanagarind hospital
Songkhla, 90110, Thailand
Adana City Hospital
Adana, 01170, Turkey (Türkiye)
Cukurova University Medical Faculty
Adana, 01790, Turkey (Türkiye)
Ankara Etlik Speciality Hospital
Ankara, 06170, Turkey (Türkiye)
Hacettepe University Medical Faculty
Ankara, 06230, Turkey (Türkiye)
Gazi University Medical Faculty
Ankara, 06500, Turkey (Türkiye)
Ankara Bilkent Sehir Hastanesi
Ankara, 06800, Turkey (Türkiye)
Akdeniz University Medical Faculty
Antalya, 07059, Turkey (Türkiye)
Bursa Yuksek Ihtisas Training and Research Hospital
Bursa, 16310, Turkey (Türkiye)
Pamukkale Universitesi Tip Fakultesi Hastanesi
Denizli, 20160, Turkey (Türkiye)
Siyami Ersek Training and Research Hospital
Istanbul, 34668, Turkey (Türkiye)
Marmara University Medical Faculty
Istanbul, 34899, Turkey (Türkiye)
SBU Izmir Tepecik Egitim Ve Arastirma Hastanesi
Izmir, 35020, Turkey (Türkiye)
Ege Universitesi Tip Fakultesi Hastanesi
Izmir, 35100, Turkey (Türkiye)
Dokuz Eylul Universitesi Tip Fakültesi Hastanesi
Izmir, 35330, Turkey (Türkiye)
Kartal Kosuyolu Yuksek Ihtisas Egitim Ve Arastirma Hastanesi
Kartal Istanbul, 34865, Turkey (Türkiye)
Mersin University Medical Faculty
Mersin, 33110, Turkey (Türkiye)
CNE 'Cherkasy Regional Cardiological Center of Cherkasy Regional Council'
Cherkassy, 18000, Ukraine
Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
Cherkasy, 18009, Ukraine
MI 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiac Surgery'
Dnipro, 49070, Ukraine
CNE' City Clinical Hospital #8' of Kharkiv City Council
Kharkiv, 61176, Ukraine
SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
Kyiv, 02000, Ukraine
State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine
Kyiv, 03680, Ukraine
Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'
Lviv, 79010, Ukraine
Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council
Ternopil, 46002, Ukraine
Royal Free Hospital
London, NW3 2QG, United Kingdom
Freeman Hospital
Newcastle upon Tyne, NE7 7DN, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital
Sheffield, S10 2RX, United Kingdom
Hanoi Medical University Hospital
Hanoi, Vietnam
Cho Ray Hospital
Ho Chi Minh City, 700000, Vietnam
Tam Anh Hospital
Ho Chi Minh City, 700000, Vietnam
Tam Duc Heart Hospital
Ho Chi Minh City, 700000, Vietnam
University Medical Center Ho Chi Minh city
Ho Chi Minh City, 700000, Vietnam
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Actelion Clinical Trials
Actelion
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2020
First Posted
February 18, 2020
Study Start
June 30, 2020
Primary Completion
October 7, 2025
Study Completion (Estimated)
February 20, 2029
Last Updated
April 13, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson \& Johnson is available at www.janssen.com/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu.