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

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

935

Participants

Timeline

Start Date

June 30, 2020

Primary Completion Date

October 7, 2025

Study Completion Date

February 20, 2029

Conditions
Pulmonary Arterial Hypertension
Interventions
DRUG

Macitentan 10 mg

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

DRUG

Macitentan 37.5 mg

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

DRUG

Macitentan 75 mg

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

DRUG

Placebo

Participants will receive matching placebo film-coated tablets orally.

Trial Locations (274)

112

Taipei Veterans General Hospital, Taipei

372

Oslo University Hospital, Oslo

704

National Cheng Kung University Hospital, Tainan City

1070

ULB Hôpital Erasme, Brussels

1083

Semmelweis Egyetem,Pulmonológiai Klinika, Budapest

1090

Medical University Vienna, Vienna

1096

Gottsegen Gyorgy Orszagos Kardiovaszkularis Intezet Felnott kardiologiai osztaly, Budapest

1309

Multiprofile Hospital For Active Treatment National Cardiology Hospital, Ead, Sofia

1478

Akershus Universitetssykehus, Nordbyhagen

1750

University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD, Sofia

1820

Dr Kalla, Lenasia

2000

Instituto Medico de La Fundacion Estudios Clinicos, Rosario

2010

St Vincent's hospital, Darlinghurst

2050

Royal Prince Alfred Hospital, Camperdown

2145

Westmead Hospital, Westmead

3000

UZ Leuven, Leuven

3080

Seoul National University Hospital, Seoul

4020

Ordensklinikum Linz GmbH Elisabethinen, Linz

4032

The Prince Charles Hospital, Chermside

5042

Flinders Medical Centre, Bedford Park

6150

Fiona Stanley Hospital, Murdoch

6720

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

7000

Royal Hobart Hospital, Hobart

7624

Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar, Pécs

8003

Hosp. Del Mar, Barcelona

8036

LKH-Univ. Klinikum Graz, Graz

8200

Århus Universitetshospital, Skejby, Hjertemedicinsk Afdeling B, Aarhus

10002

National Taiwan University Hospital, Taipei

10029

Mount Sinai, New York

10032

Columbia University, New York

10400

Phramongkutklao Hospital and Medical College, Bangkok

Ramathibodi Hospital Mahidol University, Bangkok

10449

Mackay Memorial Hospital, Taipei

10700

Siriraj Hospital Mahidol University, Bangkok

10990

Hospital Pulau Pinang, George Town

11000

University Clinical Center of Serbia, Belgrade

11501

Winthrop University Hospital, Mineola

11528

Alexandra General Hospital of Athens, Athens

11564

King Faisal Specialist Hospital & Research Center, Riyadh

11794

Stony Brook University Medical Center, Stony Brook

13915

Aphm - Hopital Nord, Marseille

14080

Instituto Nacional de Cardiologia Dr. Ignacio Chavez, Mexico City

15212

Allegheny General Hospital of Research, Pittsburgh

16310

Bursa Yuksek Ihtisas Training and Research Hospital, Bursa

18000

CNE 'Cherkasy Regional Cardiological Center of Cherkasy Regional Council', Cherkassy

18009

Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council, Cherkasy

19096

Lankenau Medical Center, Wynnewood

20070

Pamukkale University Medical Faculty, Denizli

20162

ASST Grande Ospedale Metropolitano Niguarda, Milan

21204

Institute for Pulmonary Disease of Vojvodina, Kamenitz

27100

Fondazione IRCCS Policlinico San Matteo, Pavia

28041

Hosp. Univ. 12 de Octubre, Madrid

28046

Hosp. Univ. La Paz, Madrid

28222

Hosp. Univ. Pta. de Hierro Majadahonda, Madrid

29200

CHU de Brest - Hopital de la Cavale Blanche, Brest

29603

Hosp. Costa Del Sol, Málaga

29621

AnMed Health, Anderson

30309

Piedmont Healthcare, Atlanta

30342

Northside Hospital, Atlanta

30625

Medizinische Hochschule Hannover, Hanover

32545

Ruhr Universitat Bochum Diabeteszentrum, Bad Oeynhausen

33110

Mersin University Medical Faculty, Mersin

34362

Carmel Medical Center, Haifa

34668

Siyami Ersek Training and Research Hospital, Istanbul

34865

Kartal Kosuyolu Yuksek Ihtisas Egitim Ve Arastirma Hastanesi, Kartal Istanbul

34899

Marmara University Medical Faculty, Istanbul

35100

Ege University Medical Faculty, Izmir

35120

Tepecik Training and Research Hospital, Izmir

35330

Dokuz Eylul University Medical Faculty, Izmir

37007

Hosp Clinico Univ de Salamanca, Salamanca

40002

Srinagarind Hospital, Khon Kaen University, Khon Kaen

40202

Norton Pulmonary Specialists, Louisville

41125

AOU Di Modena Policlinico Di Modena, Modena

41334

University Hospital Of Larissa, Larissa

42277

CHU Saint Etienne Hopital Nord, Saint-Priest-en-Jarez

43000

Hospital Serdang, Kajang

44657

Consultorio Privado del Dr. Gabriel Arturo Ramos Lopez, Guadalajara

45219

Lindner Clinical Trial Center/Christ Hospital, Cincinnati

46002

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

46202

Indiana University, Indianapolis

46260

St. Vincent Medical Group, Inc., Indianapolis

49070

MI 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiac Surgery', Dnipro

50020

Maharaj Nakorn Chiang Mai hospital Faculty of Medicine, Chiang Mai

50400

Institut Jantung Negara (National Heart Institute), Kuala Lumpur

52242

University Of Iowa - Hospitals & Clinics, Iowa City

52787

Operadora de Hospitales Angeles SA de CV Hospital Angeles Lomas, México

53215

Troy Beaumont, Troy

53226

Medical College Of Wisconsin, Milwaukee

53792

University of Wisconsin Hospital and Clinics, Madison

54636

Ahepa University General Hospital of Thessaloniki, Thessaloniki

56124

Fondazione Toscana Gabriele Monasterio CNR, Pisa

58260

Centro de Investigacion Clinica Chapultepec, Morelia

59046

King Fahad Medical City, Riyadh

60453

Advocate Christ Medical Center, Oak Lawn

61176

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

63110

Saint Louis University Academic Pavillion, St Louis

64103

Govindaswamy Kuppuswamy Naidu Memorial Hospital, Coimbatore

64460

Hospital Universitario Dr Jose Eleuterio Gonzalez, Monterrey

64718

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

70300

Yitzhak Shamir Medical Center, Ẕerifin

73112

Integris Baptist Office, Oklahoma City

75093

Baylor Scott White - Plano, Plano

75390

UT Southwestern Medical Center, Dallas

76100

Kaplan Medical Center, Rehovot

77030

Baylor College of Medicine (BCM) - Baylor Heart Clinic, Houston

79010

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

80206

National Jewish Health, Denver

80214

Uniwersyteckie Centrum Kliniczne, Gdansk

81377

Medizinische Klinik und Poliklinik V Klinikum Grosshadern der LMU, München

85054

Mayo Clinic, Phoenix

85258

Arizona Pulmonary Specialists, Ltd, Scottsdale

89511

Reno Heart Institute, Reno

90033

USC Keck, Los Angeles

90110

Songklanagarind hospital, Songkhla

91031

Shaare Zedek Medical Center, Jerusalem

92037

Scripps Memorial Hospital, La Jolla

93053

Universitaetsklinikum Regensburg, Regensburg

93105

Jeffrey S. Sager, MD Medical Corporation, Santa Barbara

94270

Hopital Bicetre Aphp Hopitaux Universitaires Paris Sud, Le Kremlin-Bicêtre

94300

Sarawak Heart Center, Kota Samarahan

100020

Beijing Chaoyang Hospital, Beijing

100029

Beijing Anzhen Hospital, Beijing

100730

Peking Union Medical College Hospital, Beijing

110000

The General Hospital of Northern Theater Command, Shenyang

110002

GB Pant Institute of Post Graduate Medical Education & Research, New Delhi

110004

Shengjing Hospital Of China Medical University, Shenyang

110060

Sir Ganga Ram Hospital, New Delhi

119228

National University Heart Centre, Singapore, Singapore

121309

Moscow City Clinical Hospital No.51, Moscow

121552

National Medical Research Center of Cardiology of MoH of Russian Federation, Moscow

169609

National Heart Centre (NHC) Singapore, Singapore

197341

National medical Research Center n.a. V.A.Almazov of MoH of Russian Federation, Saint Petersburg

200433

Shanghai Pulmonary Hospital, Shanghai

201112

Renji Hospital, Shanghai

220036

The Republican Scientific-Practical Center ''Cardiology'', Minsk

220143

Minsk Regional Clinical Hospital, Minsk

300052

Tianjin Medical University General Hospital, Tianjin

380006

NHL Medical College (SVP Hospital IMSR), Ahmedabad

381060

Cims Hospital, Ahmedabad

395001

B.D. Mehta Mahavir Heart Institute, Surat

400008

Volgograd Regional Clinical Cardiology Center, Volgograd

400016

The First Affiliated Hospital of Chongqing Medical University, Chongqing

410011

The Second Xiangya Hospital of Central South Hospital, Changsha

420101

State Autonomous HealthCare Institution 'Interregional Clinical Diagnostic Center', Kazan'

443070

Samara Regional Clinical Cardiological Dispensary, Samara

454076

Chelyabinsk Regional Clinical Hospital, Chelyabinsk

500034

Renova Century Hospitals, Hyderabad

Care Hospitals, Hyderbad

510120

The First Affiliated Hospital of Guangzhou Medical University, Guangzhou

560099

Narayana Hrudayalaya Limited, Bangalore

603203

SRM Medical College Hospital & Research Centre, Chengalpetu

605008

Jawaharlal Institute of Postgraduate Medical Education and Research, Puducherry

610041

West China Hospital Sichuan University, Chengdu

625032

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

650002

Scientific and Research Institution of Cardiovascular Diseases Complex Problems, Kemerovo

656055

Altay Regional Cardiological Dispensary, Barnaul

681004

Centro Cardiovascular Colombiano Clínica Santa María, Medellín

700000

Cho Ray Hospital, Ho Chi Minh City

Tam Anh Hospital, Ho Chi Minh City

Tam Duc Heart Hospital, Ho Chi Minh City

University Medical Center Ho Chi Minh city, Ho Chi Minh City

700099

Rabindranath Tagore International Institute of Cardiac Sciences, Kolkata

710061

The First Affiliated Hospital of Xian Jiaotong University, Xi'an

713216

HealthWorld Hospitals, Durgapur

760042

Clínica Imbanaco S.A.S., Santiago de Cali

1101131

Fundacion Neumologica Colombiana, Bogotá

5265601

The Chaim Sheba Medical Center, Tel Litwinsky

6810002

Fundacion Cardiovascular de Colombia, Bucaramanga - Piedecuesta - Valle de Menzuli

90502-2006

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Torrance

33331 3609

Cleveland Clinic, Weston

70112 7021

Louisiana State University, New Orleans

48109-5000

University of Michigan, Ann Arbor

63110-1032

Washington University School Of Medicine, St Louis

68198-2265

University of Nebraska Medical Center, Omaha

27710-4000

Duke, Durham

97220-9442

The Oregon Clinic, Portland

97225-6652

Oregon Pulmonary Clinic, Portland

97239-3011

Oregon Health And Science University, Portland

19104-5545

University of Pennsylvania, Philadelphia

78229-3771

San Antonio Methodist TX Transplant Physicians Group, San Antonio

05405

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

C1039AAO

Sanatorio de la Trinidad Mitre, Buenos Aires

C1180AAX

Sanatorio Guemes, C.a.b.a.

1199ABB

Hospital Italiano de Buenos Aires, Caba

C1048AAN

Sanatorio Ramon Cereijo, Caba

C1426ABP

Centro Médico Dra. De Salvo, Caba

W3400AMZ

Instituto de Cardiologia de Corrientes, Corrientes

S2000DSR

Instituto Cardiovascular de Rosario, Rosario

30130-100

Universidade Federal De Minas Gerais - Hospital das Clínicas, Belo Horizonte

30441-070

Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa, Belo Horizonte

70840-901

Empresa Brasileira de Servicos Hospitalares-EBSERH-Hospital Universitario de Brasilia, Brasília

83430-000

Sociedade Hospitalar Angelina Caron - Hospital Angelina Caron, Campina Grande do Sul

80060-240

Ceti - Centro de Estudos Em Terapias Inovadoras, Curitiba

88020-210

Ynova Pesquisa Clinica, Florianópolis

74605-020

Universidade Federal de Goias - Hospital das Clinicas da UFG, Goiânia

90035-003

Hospital das Clinicas de Porto Alegre, Porto Alegre

90610-000

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS, Porto Alegre

50070-902

Instituto de Medicina Integral Professor Fernando Figueira, Recife

09060 870

Fundacao do ABC Centro Universitario FMABC, Santo André

04012-909

Secretaria de Estado da Saude Instituto Dante Pazzanese de Cardiologia, São Paulo

05403-000

Hospital Das Clinicas Da Faculdade De Medicina Da USP, São Paulo

L8N 4A6

St. Joseph's Health Centre, Hamilton

K1Y 4W7

University of Ottawa Heart Institute, Ottawa

M5G2C4

University Health Network - Toronto General Hospital, Toronto

H3T 1E2

Jewish General Hospital, Montreal

Unknown

Zhongshan Hospital Fudan University, Shanghai

Hôpital Côte de Nacre, Caen

CHRU de Lille Hopital Claude Huriez, Lille

Hopital Larrey CHU de Toulouse, Toulouse

Milpark Hospital, Johannesburg

Hanoi Medical University Hospital, Hanoi

0000000

Hospital Universidad del Norte, Soledad

128 08

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

06001

Centre Hospitalier Universitaire - de Nice - Hopital Pasteur, Nice

681 00

University Hospital of Alexandroupolis, Alexandroupoli

08100

Ospedale San Francesco, Nuoro

00168

Policlinico Gemelli Universita Cattolica, Roma

113-8655

The University of Tokyo Hospital, Bunkyō City

812 8582

Kyushu University Hospital, Fukuoka

737-8505

Kure Kyosai Hospital, Hiroshima

890-8544

Kagoshima University Hospital, Kagoshima

216 8511

St Marianna University Hospital, Kanagawa

920 8641

Kanazawa University Hospital, Kanazawa

650 0017

Kobe University Hospital, Kobe

830-0011

Kurume University Hospital, Kurume

602-8566

University Hospital Kyoto Prefectural University of Medicine, Kyoto

606 8507

Kyoto University Hospital, Kyoto

390 8621

Shinshu University Hospital, Matsumoto

852-8501

Nagasaki University Hospital, Nagasaki

466 8560

Nagoya University Hospital, Nagoya

467 8602

Nagoya City University Hospital, Nagoya

951 8520

Niigata University Medical And Dental Hospital, Niigata

700 8558

Okayama University Hospital, Okayama

701-1192

National Hospital Organization Okayama Medical Center, Okayama

060-8543

Sapporo Medical University Hospital, Sapporo

060-8648

Hokkaido University Hospital, Sapporo

564-8565

National Cerebral and Cardiovascular Center, Suita-Shi

113-8431

Juntendo University Hospital, Tokyo

470-1192

Fujita Health University Hospital, Toyoake

305 8576

University of Tsukuba Hospital, Tsukuba

1081 HV

VUMC Amsterdam, Amsterdam

3435 CM

St. Antonius Ziekenhuis Nieuwegein, Nieuwegein

6525 GA

Radboud Umcn, Nijmegen

3015 CN

Erasmus MC, Rotterdam

15 276

Uniwersytecki Szpital Kliniczny w Bialymstoku, Bialystok

85-168

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

40 635

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

31 202

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

70 111

Uniwersytecki Szpital Kliniczny nr 2 PUM w Szczecinie, Szczecin

02 507

Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji, Warsaw

51 124

Wojewodzki Szpital Specjalistyczny we Wroclawiu Osrodek Badawczo Rozwojowy, Wroclaw

3004-561

Uls Coimbra - Hosp. Univ. Coimbra, Coimbra

1169-024

Uls Sao Jose - Hosp. Santa Marta, Lisbon

1769-001

Uls Santa Maria - Hosp. Pulido Valente, Lisbon

833 48

Narodny ustav srdcovych a cievnych chorob, Bratislava

040 11

The Eastern Slovakia Institute of Cardiovascular Diseases, Košice

03722

Severance Hospital Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

08035

Hosp Univ Vall D Hebron, Barcelona

413 45

Sahlgrenska Universitetsjukhuset, Gothenburg

221 85

Skanes universitetssjukhus, Lund

01170

Adana City Hospital, Adana

01790

Cukurova University Medical Faculty, Adana

06170

Ankara Etlik Speciality Hospital, Ankara

06230

Hacettepe University Medical Faculty, Ankara

06500

Gazi University Medical Faculty, Ankara

06800

Ankara Bilkent Sehir Hastanesi, Ankara

07059

Akdeniz University Medical Faculty, Antalya

02000

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

03680

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

NW3 2QG

Royal Free Hospital, London

NE7 7DN

Freeman Hospital, Newcastle upon Tyne

S10 2RX

Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital, Sheffield

Sponsors

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INDUSTRY

NCT04273945 - Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension | Biotech Hunter | Biotech Hunter