AzTrials
AzTrials

Pulmonary Arterial HypertensionPhase 3UNISUSNCT04273945

Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension

A Phase 3 study testing Macitentan 10 mg, Macitentan 37.5 mg and Macitentan 75 mg in people with Pulmonary Arterial Hypertension, run by Actelion at 274 sites in 42 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pulmonary Arterial Hypertension
What is being tested?
Macitentan 10 mg, Macitentan 37.5 mg and Macitentan 75 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
935 participants
Where
274 sitesin 42 countries
Study dates
30 Jun 2020to 20 Feb 2029
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

  • 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

Who cannot join

  • 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

Trial locations and contacts

274 sites in 42 countries.

274 sites in 42 countries

United States43 sites

  • AnMed Health

    Anderson, South Carolina, 29621

  • University of Michigan

    Ann Arbor, Michigan, 48109-5000

  • Piedmont Healthcare

    Atlanta, Georgia, 30309

  • Northside Hospital

    Atlanta, Georgia, 30342

  • The Oregon Clinic Pulmonary West

    Beaverton, Oregon, 97008

  • The Robert Larner, M.D. College of Medicine at The University of Vermont

    Burlington, Vermont, 05405

  • Lindner Clinical Trial Center/Christ Hospital

    Cincinnati, Ohio, 45219

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • National Jewish Health

    Denver, Colorado, 80206

  • Duke

    Durham, North Carolina, 27710-4000

  • Baylor College of Medicine (BCM) - Baylor Heart Clinic

    Houston, Texas, 77030

  • Indiana University

    Indianapolis, Indiana, 46202

  • St. Vincent Medical Group, Inc.

    Indianapolis, Indiana, 46260

  • University Of Iowa - Hospitals & Clinics

    Iowa City, Iowa, 52242

  • Scripps Memorial Hospital

    La Jolla, California, 92037

  • USC Keck

    Los Angeles, California, 90033

  • Norton Pulmonary Specialists

    Louisville, Kentucky, 40202

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Medical College Of Wisconsin

    Milwaukee, Wisconsin, 53226

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Louisiana State University

    New Orleans, Louisiana, 70112 7021

  • Mount Sinai

    New York, New York, 10029

  • Columbia University

    New York, New York, 10032

  • Advocate Christ Medical Center

    Oak Lawn, Illinois, 60453

  • Integris Baptist Office

    Oklahoma City, Oklahoma, 73112

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-2265

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104-5545

  • Mayo Clinic

    Phoenix, Arizona, 85054

  • Allegheny General Hospital of Research

    Pittsburgh, Pennsylvania, 15212

  • Baylor Scott White - Plano

    Plano, Texas, 75093

  • The Oregon Clinic

    Portland, Oregon, 97220-9442

  • Oregon Health And Science University

    Portland, Oregon, 97239-3011

  • Reno Heart Institute

    Reno, Nevada, 89511

  • San Antonio Methodist TX Transplant Physicians Group

    San Antonio, Texas, 78229-3771

  • Jeffrey S. Sager, MD Medical Corporation

    Santa Barbara, California, 93105

  • Arizona Pulmonary Specialists, Ltd

    Scottsdale, Arizona, 85258

  • Washington University School Of Medicine

    St Louis, Missouri, 63110-1032

  • Saint Louis University Academic Pavillion

    St Louis, Missouri, 63110

  • Stony Brook University Medical Center

    Stony Brook, New York, 11794

  • Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

    Torrance, California, 90502-2006

  • Troy Beaumont

    Troy, Michigan, 53215

  • Cleveland Clinic

    Weston, Florida, 33331 3609

  • Lankenau Medical Center

    Wynnewood, Pennsylvania, 19096

Other trials in United States

Japan23 sites

  • The University of Tokyo Hospital

    Bunkyō City, 113-8655

  • Kyushu University Hospital

    Fukuoka, 812 8582

  • Kure Kyosai Hospital

    Hiroshima, 737-8505

  • Kagoshima University Hospital

    Kagoshima, 890 8520

  • St Marianna University Hospital

    Kanagawa, 216 8511

  • Kanazawa University Hospital

    Kanazawa, 920 8641

  • Kobe University Hospital

    Kobe, 650 0017

  • Kurume University Hospital

    Kurume, 830-0011

  • University Hospital Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • Kyoto University Hospital

    Kyoto, 606 8507

  • Shinshu University Hospital

    Matsumoto, 390 8621

  • Nagasaki University Hospital

    Nagasaki, 852-8501

  • Nagoya University Hospital

    Nagoya, 466 8560

  • Nagoya City University Hospital

    Nagoya, 467 8602

  • Niigata University Medical And Dental Hospital

    Niigata, 951 8520

  • Okayama University Hospital

    Okayama, 700 8558

  • National Hospital Organization Okayama Medical Center

    Okayama, 701-1192

  • Sapporo Medical University Hospital

    Sapporo, 060 8543

  • Hokkaido University Hospital

    Sapporo, 060-8648

  • National Cerebral and Cardiovascular Center

    Suita-Shi, 564-8565

  • Juntendo University Hospital

    Tokyo, 113-8431

  • Fujita Health University Hospital

    Toyoake, 470-1192

  • University of Tsukuba Hospital

    Tsukuba, 305 8576

Other trials in Japan

Turkey (Türkiye)16 sites

  • Adana City Hospital

    Adana, 01170

  • Cukurova University Medical Faculty

    Adana, 01790

  • Ankara Etlik Speciality Hospital

    Ankara, 06170

  • Hacettepe University Medical Faculty

    Ankara, 06230

  • Gazi University Medical Faculty

    Ankara, 06500

  • Ankara Bilkent Sehir Hastanesi

    Ankara, 06800

  • Akdeniz University Medical Faculty

    Antalya, 07059

  • Bursa Yuksek Ihtisas Training and Research Hospital

    Bursa, 16310

  • Pamukkale Universitesi Tip Fakultesi Hastanesi

    Denizli, 20160

  • Siyami Ersek Training and Research Hospital

    Istanbul, 34668

  • Marmara University Medical Faculty

    Istanbul, 34899

  • SBU Izmir Tepecik Egitim Ve Arastirma Hastanesi

    Izmir, 35020

  • Ege Universitesi Tip Fakultesi Hastanesi

    Izmir, 35100

  • Dokuz Eylul Universitesi Tip Fakültesi Hastanesi

    Izmir, 35330

  • Kartal Kosuyolu Yuksek Ihtisas Egitim Ve Arastirma Hastanesi

    Kartal Istanbul, 34865

  • Mersin University Medical Faculty

    Mersin, 33110

Other trials in Turkey (Türkiye)

China14 sites

  • Beijing Chaoyang Hospital

    Beijing, 100020

  • Beijing Anzhen Hospital

    Beijing, 100029

  • Peking Union Medical College Hospital

    Beijing, 100730

  • The Second Xiangya Hospital of Central South Hospital

    Changsha, 410011

  • West China Hospital Sichuan University

    Chengdu, 610041

  • The First Affiliated Hospital of Chongqing Medical University

    Chongqing, 400016

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, 510120

  • Shanghai Pulmonary Hospital

    Shanghai, 200433

  • Renji Hospital

    Shanghai, 201112

  • Zhongshan Hospital Fudan University

    Shanghai

  • The General Hospital of Northern Theater Command

    Shenyang, 110000

  • Shengjing Hospital Of China Medical University

    Shenyang, 110004

  • Tianjin Medical University General Hospital

    Tianjin, 300052

  • The First Affiliated Hospital of Xian Jiaotong University

    Xi'an, 710061

Other trials in China

Brazil13 sites

  • Universidade Federal De Minas Gerais - Hospital das Clínicas

    Belo Horizonte, 30130-100

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

    Belo Horizonte, 30441-070

  • Empresa Brasileira de Servicos Hospitalares-EBSERH-Hospital Universitario de Brasilia

    Brasília, 70840-901

  • Sociedade Hospitalar Angelina Caron - Hospital Angelina Caron

    Campina Grande do Sul, 83430-000

  • Ceti - Centro de Estudos Em Terapias Inovadoras

    Curitiba, 80060-240

  • Grupo ELORA Centro de Pesquisa e Ensino em Saude de Santa Catarina

    Florianópolis, 88020 210

  • Hospital das Clinicas - UFG

    Goiânia, 74605 020

  • Hospital De Clinicas De Porto Alegre

    Porto Alegre, 90035 903

  • Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

    Porto Alegre, 90610-000

  • Instituto de Medicina Integral Professor Fernando Figueira

    Recife, 50070-902

  • Instituto Dante Pazzanese de Cardiologia

    São Paulo, 04012-909

  • Hospital Das Clinicas Da Faculdade De Medicina Da USP

    São Paulo, 05403-000

  • Cepes - Fmabc

    São Paulo, 09060-870

Other trials in Brazil

India13 sites

  • NHL Medical College (SVP Hospital IMSR)

    Ahmedabad, 380006

  • Cims Hospital

    Ahmedabad, 381060

  • Narayana Hrudayalaya Limited

    Bangalore, 560099

  • SRM Medical College Hospital & Research Centre

    Chengalpetu, 603203

  • Govindaswamy Kuppuswamy Naidu Memorial Hospital

    Coimbatore, 64103

  • HealthWorld Hospitals

    Durgapur, 713216

  • Renova Century Hospitals

    Hyderabad, 500034

  • Care Hospitals

    Hyderbad, 500034

  • Rabindranath Tagore International Institute of Cardiac Sciences

    Kolkata, 700099

  • GB Pant Institute of Post Graduate Medical Education & Research

    New Delhi, 110002

  • Sir Ganga Ram Hospital

    New Delhi, 110060

  • Jawaharlal Institute of Postgraduate Medical Education and Research

    Puducherry, 605008

  • B.D. Mehta Mahavir Heart Institute

    Surat, 395001

Other trials in India

Russia10 sites

  • Altay Regional Cardiological Dispensary

    Barnaul, 656055

  • Chelyabinsk Regional Clinical Hospital

    Chelyabinsk, 454076

  • State Autonomous HealthCare Institution 'Interregional Clinical Diagnostic Center'

    Kazan', 420101

  • Scientific and Research Institution of Cardiovascular Diseases Complex Problems

    Kemerovo, 650002

  • Moscow City Clinical Hospital No.51

    Moscow, 121309

  • National Medical Research Center of Cardiology of MoH of Russian Federation

    Moscow, 121552

  • National medical Research Center n.a. V.A.Almazov of MoH of Russian Federation

    Saint Petersburg, 197341

  • Samara Regional Clinical Cardiological Dispensary

    Samara, 443070

  • State Autonomous Healthcare Institution of Tyumen Region 'Scientific and Practical Medical Center'

    Tyumen, 625032

  • Volgograd Regional Clinical Cardiology Center

    Volgograd, 400008

Other trials in Russia

Argentina8 sites

  • Sanatorio de la Trinidad Mitre

    Buenos Aires, C1039AAO

  • Sanatorio Guemes

    C.a.b.a., C1180AAX

  • Hospital Italiano de Buenos Aires

    Caba, 1199ABB

  • Sanatorio Ramon Cereijo

    Caba, C1048AAN

  • Centro Médico Dra. De Salvo

    Caba, C1426ABP

  • Instituto de Cardiologia de Corrientes

    Corrientes, W3400AMZ

  • Instituto Medico de La Fundacion Estudios Clinicos

    Rosario, 2000

  • Instituto Cardiovascular de Rosario

    Rosario, S2000DSR

Other trials in Argentina

France8 sites

  • CHU de Brest - Hopital de la Cavale Blanche

    Brest, 29200

  • Hôpital Côte de Nacre

    Caen

  • Hopital Bicetre Aphp Hopitaux Universitaires Paris Sud

    Le Kremlin-Bicêtre, 94270

  • CHRU de Lille Hopital Claude Huriez

    Lille

  • Aphm - Hopital Nord

    Marseille, 13915

  • Centre Hospitalier Universitaire - de Nice - Hopital Pasteur

    Nice, 06002

  • CHU Saint Etienne Hopital Nord

    Saint-Priest-en-Jarez, 42277

  • Hopital Larrey CHU de Toulouse

    Toulouse

Other trials in France

Poland8 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15 276

  • Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy, Klinika Kardiologii

    Bydgoszcz, 85-168

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, 80214

  • SPSK nr 7 SUM w Katowicach Gornoslaskie Centrum Medyczne im Prof Leszka Gieca

    Katowice, 40 635

  • Krakowski Szpital Specjalityczny im Jana Pawla II Oddzial Kliniczny Chorob Serca i Naczyn

    Krakow, 31 202

  • Uniwersytecki Szpital Kliniczny nr 2 PUM w Szczecinie

    Szczecin, 70 111

  • Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji

    Warsaw, 02 507

  • Wojewodzki Szpital Specjalistyczny we Wroclawiu Osrodek Badawczo Rozwojowy

    Wroclaw, 51 124

Other trials in Poland

Ukraine8 sites

  • CNE 'Cherkasy Regional Cardiological Center of Cherkasy Regional Council'

    Cherkassy, 18000

  • Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council

    Cherkasy, 18009

  • MI 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiac Surgery'

    Dnipro, 49070

  • CNE' City Clinical Hospital #8' of Kharkiv City Council

    Kharkiv, 61176

  • SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine

    Kyiv, 02000

  • State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine

    Kyiv, 03680

  • Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'

    Lviv, 79010

  • Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council

    Ternopil, 46002

Other trials in Ukraine

Australia7 sites

  • Flinders Medical Centre

    Bedford Park, 5042

  • Royal Prince Alfred Hospital

    Camperdown, 2050

  • The Prince Charles Hospital

    Chermside, 4032

  • St Vincent's hospital

    Darlinghurst, 2010

  • Royal Hobart Hospital

    Hobart, 7000

  • Fiona Stanley Hospital

    Murdoch, 6150

  • Westmead Hospital

    Westmead, 2145

Other trials in Australia

Spain7 sites

  • Hosp Univ Vall D Hebron

    Barcelona, 08035

  • Hosp. Del Mar

    Barcelona, 8003

  • Hosp. Univ. 12 de Octubre

    Madrid, 28041

  • Hosp. Univ. La Paz

    Madrid, 28046

  • Hosp. Univ. Pta. de Hierro Majadahonda

    Madrid, 28222

  • Hosp. Costa Del Sol

    Málaga, 29603

  • Hosp Clinico Univ de Salamanca

    Salamanca, 37007

Other trials in Spain

Italy6 sites

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • AOU Di Modena Policlinico Di Modena

    Modena, 41125

  • Ospedale San Francesco

    Nuoro, 08100

  • Fondazione IRCCS Policlinico San Matteo

    Pavia, 27100

  • Fondazione Toscana Gabriele Monasterio CNR

    Pisa, 56124

  • Policlinico Gemelli Universita Cattolica

    Roma, 00168

Other trials in Italy

Mexico6 sites

  • Consultorio Privado del Dr. Gabriel Arturo Ramos Lopez

    Guadalajara, 44657

  • Operadora de Hospitales Angeles SA de CV Hospital Angeles Lomas

    México, 52787

  • Instituto Nacional de Cardiologia Dr. Ignacio Chavez

    Mexico City, 14080

  • Hospital Universitario Dr Jose Eleuterio Gonzalez

    Monterrey, 64460

  • Unidad de Investigacion Clinica en Medicina S.C. (UDICEM)

    Monterrey, 64718

  • Centro de Investigacion Clinica Chapultepec

    Morelia, 58260

Other trials in Mexico

Thailand6 sites

  • Phramongkutklao Hospital and Medical College

    Bangkok, 10400

  • Ramathibodi Hospital Mahidol University

    Bangkok, 10400

  • Siriraj Hospital Mahidol University

    Bangkok, 10700

  • Maharaj Nakorn Chiang Mai hospital Faculty of Medicine

    Chiang Mai, 50020

  • Srinagarind Hospital, Khon Kaen University

    Khon Kaen, 40002

  • Songklanagarind hospital

    Songkhla, 90110

Other trials in Thailand

Colombia5 sites

  • Fundacion Neumologica Colombiana

    Bogotá, 1101131

  • Fundacion Cardiovascular de Colombia

    Bucaramanga - Piedecuesta - Valle de Menzuli, 6810002

  • Clínica Imbanaco S.A.S.

    Cali, 760042

  • Centro Cardiovascular Colombiano Clínica Santa María

    Medellín, 681004

  • Hospital Universidad del Norte

    Soledad, 0000000

Other trials in Colombia

Israel5 sites

  • Carmel Medical Center

    Haifa, 34362

  • Shaare Zedek Medical Center

    Jerusalem, 91031

  • Kaplan Medical Center

    Rehovot, 76100

  • The Chaim Sheba Medical Center

    Tel Litwinsky, 5265601

  • Yitzhak Shamir Medical Center

    Ẕerifin, 70300

Other trials in Israel

Vietnam5 sites

  • Hanoi Medical University Hospital

    Hanoi

  • Cho Ray Hospital

    Ho Chi Minh City, 700000

  • Tam Anh Hospital

    Ho Chi Minh City, 700000

  • Tam Duc Heart Hospital

    Ho Chi Minh City, 700000

  • University Medical Center Ho Chi Minh city

    Ho Chi Minh City, 700000

Other trials in Vietnam

Canada4 sites

  • St. Joseph's Health Centre

    Hamilton, Ontario, L8N 4A6

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • University of Ottawa Heart Institute

    Ottawa, Ontario, K1Y 4W7

  • University Health Network - Toronto General Hospital

    Toronto, Ontario, M5G2C4

Other trials in Canada

Germany4 sites

  • Ruhr Universitat Bochum Diabeteszentrum

    Bad Oeynhausen, 32545

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Medizinische Klinik und Poliklinik V Klinikum Grosshadern der LMU

    München, 81377

  • Universitaetsklinikum Regensburg

    Regensburg, 93053

Other trials in Germany

Greece4 sites

  • University Hospital of Alexandroupolis

    Alexandroupoli, 681 00

  • Alexandra General Hospital of Athens

    Athens, 11528

  • University Hospital Of Larissa

    Larissa, 41334

  • Ahepa University General Hospital of Thessaloniki

    Thessaloniki, 54636

Other trials in Greece

Hungary4 sites

  • Semmelweis Egyetem,Pulmonológiai Klinika

    Budapest, 1083

  • Gottsegen Gyorgy Orszagos Kardiovaszkularis Intezet Felnott kardiologiai osztaly

    Budapest, 1096

  • Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar

    Pécs, 7624

  • Szegedi Tudományegyetem, Általános Orvostudományi Kar, Családorvosi Intézet és rendelő

    Szeged, 6720

Other trials in Hungary

Malaysia4 sites

  • Hospital Pulau Pinang

    George Town, 10990

  • Hospital Serdang

    Kajang, 43000

  • Sarawak Heart Center

    Kota Samarahan, 94300

  • Institut Jantung Negara (National Heart Institute)

    Kuala Lumpur, 50400

Other trials in Malaysia

Netherlands4 sites

  • VUMC Amsterdam

    Amsterdam, 1081 HV

  • St. Antonius Ziekenhuis Nieuwegein

    Nieuwegein, 3435 CM

  • Radboud Umcn

    Nijmegen, 6525 GA

  • Erasmus MC

    Rotterdam, 3015 CN

Other trials in Netherlands

South Korea4 sites

  • Severance Hospital Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Samsung Medical Center

    Seoul, 06351

  • Seoul National University Hospital

    Seoul, 3080

Other trials in South Korea

Taiwan4 sites

  • National Cheng Kung University Hospital

    Tainan, 704

  • National Taiwan University Hospital

    Taipei, 10002

  • Mackay Memorial Hospital

    Taipei, 10449

  • Taipei Veterans General Hospital

    Taipei, 112

Other trials in Taiwan

Austria3 sites

  • LKH-Univ. Klinikum Graz

    Graz, 8036

  • Ordensklinikum Linz GmbH Elisabethinen

    Linz, 4020

  • Medical University Vienna

    Vienna, 1090

Other trials in Austria

Portugal3 sites

  • Uls Coimbra - Hosp. Univ. Coimbra

    Coimbra, 3004 561

  • Uls Sao Jose - Hosp. Santa Marta

    Lisbon, 1169-024

  • Uls Santa Maria - Hosp. Pulido Valente

    Lisbon, 1769-001

Other trials in Portugal

United Kingdom3 sites

  • Royal Free Hospital

    London, NW3 2QG

  • Freeman Hospital

    Newcastle upon Tyne, NE7 7DN

  • Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

    Sheffield, S10 2RX

Other trials in United Kingdom

Belarus2 sites

  • The Republican Scientific-Practical Center ''Cardiology''

    Minsk, 220036

  • Minsk Regional Clinical Hospital

    Minsk, 220143

Other trials in Belarus

Belgium2 sites

  • ULB Hôpital Erasme

    Brussels, 1070

  • UZ Leuven

    Leuven, 3000

Other trials in Belgium

Bulgaria2 sites

  • Multiprofile Hospital For Active Treatment National Cardiology Hospital, Ead

    Sofia, 1309

  • University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD

    Sofia, 1750

Other trials in Bulgaria

Norway2 sites

  • Akershus Universitetssykehus

    Nordbyhagen, 1478

  • Oslo University Hospital

    Oslo, 372

Other trials in Norway

Saudi Arabia2 sites

  • King Faisal Specialist Hospital & Research Center

    Riyadh, 11564

  • King Fahad Medical City

    Riyadh, 59046

Other trials in Saudi Arabia

Serbia2 sites

  • University Clinical Center of Serbia

    Belgrade, 11000

  • Institute for Pulmonary Disease of Vojvodina

    Kamenitz, 21204

Other trials in Serbia

Singapore2 sites

  • National University Heart Centre, Singapore

    Singapore, 119228

  • National Heart Centre (NHC) Singapore

    Singapore, 169609

Other trials in Singapore

Slovakia2 sites

  • Narodny ustav srdcovych a cievnych chorob

    Bratislava, 833 48

  • The Eastern Slovakia Institute of Cardiovascular Diseases

    Košice, 040 11

Other trials in Slovakia

South Africa2 sites

  • Milpark Hospital

    Johannesburg

  • Dr Kalla

    Lenasia, 1820

Other trials in South Africa

Sweden2 sites

  • Sahlgrenska Universitetsjukhuset

    Gothenburg, 413 45

  • Skanes universitetssjukhus

    Lund, 221 85

Other trials in Sweden

Czechia1 site

  • General University Hospital II.department of Internal Medicine-cardiology and angiology

    Prague, 128 08

Other trials in Czechia

Denmark1 site

  • Århus Universitetshospital, Skejby, Hjertemedicinsk Afdeling B

    Aarhus, 8200

Other trials in Denmark

About this study

Official title: 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

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.

Being tested
Macitentan 10 mg, Macitentan 37.5 mg, Macitentan 75 mg, Placebo
Medical subject headings
Pulmonary Arterial Hypertension

What participants receive

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

  • Macitentan 10 mgDrug

    Also called JNJ-67896062

    Participants will receive macitentan 10 mg film-coated tablets orally.

  • Macitentan 37.5 mgDrug

    Also called JNJ-67896062

    Participants will receive macitentan 37.5 mg film-coated tablets orally.

  • Macitentan 75 mgDrug

    Also called JNJ-67896062

    Participants will receive macitentan 75 mg film-coated tablets orally.

  • PlaceboDrug

    Participants will receive matching placebo film-coated tablets orally.

Study groups in NCT04273945
Study groupRoleWhat they receive
Macitentan 10 milligrams (mg) + PlaceboActive 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.
Receives: Drug: Macitentan 10 mg; Drug: Macitentan 37.5 mg; Drug: Macitentan 75 mg; Drug: Placebo
Macitentan 75 mg + PlaceboExperimentalRun-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.
Receives: Drug: Macitentan 10 mg; Drug: Macitentan 37.5 mg; Drug: Macitentan 75 mg; Drug: Placebo

What is being measured

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

  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.

    Measured: Up to 4 years

Secondary outcomes (6)

  1. Double-blind Treatment Period: Change From Baseline to Week 24 in 6MWD

    The 6MWT is a non-encouraged test performed to quantify exercise tolerance and capacity. This standardized test measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes.

    Measured: Baseline up to Week 24

  2. 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

    Number of Participants with CEC-adjudicated death or hospitalization due to PAH will be reported.

    Measured: Up to 4 years

  3. Double-blind Treatment Period: Change From Baseline to Week 24 in PAH Symptoms Based on PAH-SYMPACT Questionnaire- Cardiopulmonary Symptom Domain Score

    The Cardiopulmonary Symptoms domain consists of 6 items reported on a 5-point Likert scale (from 0 to 4). The value 0 means "no symptom" and value 4 corresponds to "very severe symptoms". The symptoms part of the PAH symptoms and impact questionnaire (PAH-SYMPACT) is completed daily for a 7-day period. The recall period of symptom items is the last 24 hours. An average Cardiopulmonary Symptoms domain score is determined based on the daily scores of the 6 items.

    Measured: Baseline up to Week 24

  4. Double-blind Treatment Period: Change From Baseline to Week 24 in PAH Symptoms Based on PAH-SYMPACT Questionnaire- Cardiovascular Symptom Domain Score

    The Cardiovascular Symptoms domain consists of 5 items reported on a 5-point Likert scale (from 0 to 4). The value 0 corresponds to "no symptoms" and value 4 corresponds to "very severe symptoms". The symptoms part of the PAH-SYMPACT is completed daily for a 7 day period. The recall period of symptom items is the last 24 hours. An average cardiovascular symptoms domain score is determined based on the daily scores of the 5 items.

    Measured: Baseline up to Week 24

  5. Double-blind Treatment Period: Time to Death Occurring Between Randomization and End of Double-blind Treatment (EDBT)

    Time to death occurring between randomization and EDBT will be reported.

    Measured: Up to 4 years

  6. Treatment Extension Period: Time to Death Occurring Between Randomization and End of Study (EOS)

    Time to death occurring between randomization and EOS will be reported.

    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 posted18 Feb 2020
  2. Study start30 Jun 2020
  3. Primary completion7 Oct 2025
  4. Study completion20 Feb 2029 (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
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
935 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04273945
Sponsor's protocol ID
CR108740
Other IDs
AC-055-315, 2019-002533-11, 2024-515669-32-00, 2019
Acronym
UNISUS
Status last verified
Oct 2026
First submitted
31 Jan 2020
Last updated
6 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Csonka D, Gargano C, Goyal N, De Meulder M, Yartsev V, Ruixo JJP. Effect of Once-Daily Macitentan 75 mg on the Pharmacokinetics of Sildenafil, Riociguat, or Rosuvastatin in Healthy Male Participants. J Clin Pharmacol. 2026 Apr;66(4):e70185. doi: 10.1002/jcph.70185.

    PubMed 42023995

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Macitentan 10 mg, Macitentan 37.5 mg and Macitentan 75 mg in people with Pulmonary Arterial Hypertension, run by Actelion at 274 sites in 42 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 5 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: under way, not looking for participants, 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 274 sites in United States, Japan, Turkey (Türkiye), China, Brazil and 37 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?

Double-blind Treatment Period: Time to First Clinical Events Committee (CEC)-adjudicated Morbidity or Mortality (M/M) Events (time frame: Up to 4 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 NCT04273945, which also lists 1 linked publication.

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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