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ACTIVE NOT RECRUITING
NCT04273945
PHASE3

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

Sponsor: Actelion

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

935

Start Date

2020-06-30

Completion Date

2029-02-20

Last Updated

2026-03-13

Healthy Volunteers

No

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.

Locations (274)

Mayo Clinic

Phoenix, Arizona, United States

Arizona Pulmonary Specialists, Ltd

Scottsdale, Arizona, United States

Scripps Memorial Hospital

La Jolla, California, United States

USC Keck

Los Angeles, California, United States

Jeffrey S. Sager, MD Medical Corporation

Santa Barbara, California, United States

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, United States

National Jewish Health

Denver, Colorado, United States

Cleveland Clinic

Weston, Florida, United States

Piedmont Healthcare

Atlanta, Georgia, United States

Northside Hospital

Atlanta, Georgia, United States

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

Indiana University

Indianapolis, Indiana, United States

St. Vincent Medical Group, Inc.

Indianapolis, Indiana, United States

University Of Iowa - Hospitals & Clinics

Iowa City, Iowa, United States

Norton Pulmonary Specialists

Louisville, Kentucky, United States

Louisiana State University

New Orleans, Louisiana, United States

University of Michigan

Ann Arbor, Michigan, United States

Troy Beaumont

Troy, Michigan, United States

Washington University School Of Medicine

St Louis, Missouri, United States

Saint Louis University Academic Pavillion

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Reno Heart Institute

Reno, Nevada, United States

Winthrop University Hospital

Mineola, New York, United States

Mount Sinai

New York, New York, United States

Columbia University

New York, New York, United States

Stony Brook University Medical Center

Stony Brook, New York, United States

Duke

Durham, North Carolina, United States

Lindner Clinical Trial Center/Christ Hospital

Cincinnati, Ohio, United States

Integris Baptist Office

Oklahoma City, Oklahoma, United States

The Oregon Clinic

Portland, Oregon, United States

Oregon Pulmonary Clinic

Portland, Oregon, United States

Oregon Health And Science University

Portland, Oregon, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Allegheny General Hospital of Research

Pittsburgh, Pennsylvania, United States

Lankenau Medical Center

Wynnewood, Pennsylvania, United States

AnMed Health

Anderson, South Carolina, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Baylor College of Medicine (BCM) - Baylor Heart Clinic

Houston, Texas, United States

Baylor Scott White - Plano

Plano, Texas, United States

San Antonio Methodist TX Transplant Physicians Group

San Antonio, Texas, United States

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

Burlington, Vermont, United States

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Medical College Of Wisconsin

Milwaukee, Wisconsin, United States

Sanatorio de la Trinidad Mitre

Buenos Aires, Argentina

Sanatorio Guemes

C.a.b.a., Argentina

Hospital Italiano de Buenos Aires

Caba, Argentina

Sanatorio Ramon Cereijo

Caba, Argentina

Centro Médico Dra. De Salvo

Caba, Argentina

Instituto de Cardiologia de Corrientes

Corrientes, Argentina

Instituto Medico de La Fundacion Estudios Clinicos

Rosario, Argentina

Instituto Cardiovascular de Rosario

Rosario, Argentina

Flinders Medical Centre

Bedford Park, Australia

Royal Prince Alfred Hospital

Camperdown, Australia

The Prince Charles Hospital

Chermside, Australia

St Vincent's hospital

Darlinghurst, Australia

Royal Hobart Hospital

Hobart, Australia

Fiona Stanley Hospital

Murdoch, Australia

Westmead Hospital

Westmead, Australia

LKH-Univ. Klinikum Graz

Graz, Austria

Ordensklinikum Linz GmbH Elisabethinen

Linz, Austria

Medical University Vienna

Vienna, Austria

The Republican Scientific-Practical Center ''Cardiology''

Minsk, Belarus

Minsk Regional Clinical Hospital

Minsk, Belarus

ULB Hôpital Erasme

Brussels, Belgium

UZ Leuven

Leuven, Belgium

Universidade Federal De Minas Gerais - Hospital das Clínicas

Belo Horizonte, Brazil

Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa

Belo Horizonte, Brazil

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

Brasília, Brazil

Sociedade Hospitalar Angelina Caron - Hospital Angelina Caron

Campina Grande do Sul, Brazil

Ceti - Centro de Estudos Em Terapias Inovadoras

Curitiba, Brazil

Ynova Pesquisa Clinica

Florianópolis, Brazil

Universidade Federal de Goias - Hospital das Clinicas da UFG

Goiânia, Brazil

Hospital das Clinicas de Porto Alegre

Porto Alegre, Brazil

Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS

Porto Alegre, Brazil

Instituto de Medicina Integral Professor Fernando Figueira

Recife, Brazil

Fundacao do ABC Centro Universitario FMABC

Santo André, Brazil

Secretaria de Estado da Saude Instituto Dante Pazzanese de Cardiologia

São Paulo, Brazil

Hospital Das Clinicas Da Faculdade De Medicina Da USP

São Paulo, Brazil

Multiprofile Hospital For Active Treatment National Cardiology Hospital, Ead

Sofia, Bulgaria

University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD

Sofia, Bulgaria

St. Joseph's Health Centre

Hamilton, Ontario, Canada

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

University Health Network - Toronto General Hospital

Toronto, Ontario, Canada

Jewish General Hospital

Montreal, Quebec, Canada

Beijing Chaoyang Hospital

Beijing, China

Beijing Anzhen Hospital

Beijing, China

Peking Union Medical College Hospital

Beijing, China

The Second Xiangya Hospital of Central South Hospital

Changsha, China

West China Hospital Sichuan University

Chengdu, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

The First Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Shanghai Pulmonary Hospital

Shanghai, China

Renji Hospital

Shanghai, China

Zhongshan Hospital Fudan University

Shanghai, China

The General Hospital of Northern Theater Command

Shenyang, China

Shengjing Hospital Of China Medical University

Shenyang, China

Tianjin Medical University General Hospital

Tianjin, China

The First Affiliated Hospital of Xian Jiaotong University

Xi'an, China

Fundacion Neumologica Colombiana

Bogotá, Colombia

Fundacion Cardiovascular de Colombia

Bucaramanga - Piedecuesta - Valle de Menzuli, Colombia

Clínica Imbanaco S.A.S.

Cali, Colombia

Centro Cardiovascular Colombiano Clínica Santa María

Medellín, Colombia

Hospital Universidad del Norte

Soledad, Colombia

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

Prague, Czechia

Århus Universitetshospital, Skejby, Hjertemedicinsk Afdeling B

Aarhus, Denmark

CHU de Brest - Hopital de la Cavale Blanche

Brest, France

Hôpital Côte de Nacre

Caen, France

Hopital Bicetre Aphp Hopitaux Universitaires Paris Sud

Le Kremlin-Bicêtre, France

CHRU de Lille Hopital Claude Huriez

Lille, France

Aphm - Hopital Nord

Marseille, France

Centre Hospitalier Universitaire - de Nice - Hopital Pasteur

Nice, France

CHU Saint Etienne Hopital Nord

Saint-Priest-en-Jarez, France

Hopital Larrey CHU de Toulouse

Toulouse, France

Ruhr Universitat Bochum Diabeteszentrum

Bad Oeynhausen, Germany

Medizinische Hochschule Hannover

Hanover, Germany

Medizinische Klinik und Poliklinik V Klinikum Grosshadern der LMU

München, Germany

Universitaetsklinikum Regensburg

Regensburg, Germany

University Hospital of Alexandroupolis

Alexandroupoli, Greece

Alexandra General Hospital of Athens

Athens, Greece

University Hospital Of Larissa

Larissa, Greece

Ahepa University General Hospital of Thessaloniki

Thessaloniki, Greece

Semmelweis Egyetem,Pulmonológiai Klinika

Budapest, Hungary

Gottsegen Gyorgy Orszagos Kardiovaszkularis Intezet Felnott kardiologiai osztaly

Budapest, Hungary

Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar

Pécs, Hungary

Szegedi Tudományegyetem, Általános Orvostudományi Kar, Családorvosi Intézet és rendelő

Szeged, Hungary

NHL Medical College (SVP Hospital IMSR)

Ahmedabad, India

Cims Hospital

Ahmedabad, India

Narayana Hrudayalaya Limited

Bangalore, India

SRM Medical College Hospital & Research Centre

Chengalpetu, India

Govindaswamy Kuppuswamy Naidu Memorial Hospital

Coimbatore, India

HealthWorld Hospitals

Durgapur, India

Renova Century Hospitals

Hyderabad, India

Care Hospitals

Hyderbad, India

Rabindranath Tagore International Institute of Cardiac Sciences

Kolkata, India

GB Pant Institute of Post Graduate Medical Education & Research

New Delhi, India

Sir Ganga Ram Hospital

New Delhi, India

Jawaharlal Institute of Postgraduate Medical Education and Research

Puducherry, India

B.D. Mehta Mahavir Heart Institute

Surat, India

Carmel Medical Center

Haifa, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Kaplan Medical Center

Rehovot, Israel

The Chaim Sheba Medical Center

Tel Litwinsky, Israel

Yitzhak Shamir Medical Center

Ẕerifin, Israel

ASST Grande Ospedale Metropolitano Niguarda

Milan, Italy

AOU Di Modena Policlinico Di Modena

Modena, Italy

Ospedale San Francesco

Nuoro, Italy

Fondazione IRCCS Policlinico San Matteo

Pavia, Italy

Fondazione Toscana Gabriele Monasterio CNR

Pisa, Italy

Policlinico Gemelli Universita Cattolica

Roma, Italy

The University of Tokyo Hospital

Bunkyō City, Japan

Kyushu University Hospital

Fukuoka, Japan

Kure Kyosai Hospital

Hiroshima, Japan

Kagoshima University Hospital

Kagoshima, Japan

St Marianna University Hospital

Kanagawa, Japan

Kanazawa University Hospital

Kanazawa, Japan

Kobe University Hospital

Kobe, Japan

Kurume University Hospital

Kurume, Japan

University Hospital Kyoto Prefectural University of Medicine

Kyoto, Japan

Kyoto University Hospital

Kyoto, Japan

Shinshu University Hospital

Matsumoto, Japan

Nagasaki University Hospital

Nagasaki, Japan

Nagoya University Hospital

Nagoya, Japan

Nagoya City University Hospital

Nagoya, Japan

Niigata University Medical And Dental Hospital

Niigata, Japan

Okayama University Hospital

Okayama, Japan

National Hospital Organization Okayama Medical Center

Okayama, Japan

Sapporo Medical University Hospital

Sapporo, Japan

Hokkaido University Hospital

Sapporo, Japan

National Cerebral and Cardiovascular Center

Suita-Shi, Japan

Juntendo University Hospital

Tokyo, Japan

Fujita Health University Hospital

Toyoake, Japan

University of Tsukuba Hospital

Tsukuba, Japan

Hospital Pulau Pinang

George Town, Malaysia

Hospital Serdang

Kajang, Malaysia

Sarawak Heart Center

Kota Samarahan, Malaysia

Institut Jantung Negara (National Heart Institute)

Kuala Lumpur, Malaysia

Consultorio Privado del Dr. Gabriel Arturo Ramos Lopez

Guadalajara, Mexico

Instituto Nacional de Cardiologia Dr. Ignacio Chavez

Mexico City, Mexico

Operadora de Hospitales Angeles SA de CV Hospital Angeles Lomas

México, Mexico

Hospital Universitario Dr Jose Eleuterio Gonzalez

Monterrey, Mexico

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

Monterrey, Mexico

Centro de Investigacion Clinica Chapultepec

Morelia, Mexico

VUMC Amsterdam

Amsterdam, Netherlands

St. Antonius Ziekenhuis Nieuwegein

Nieuwegein, Netherlands

Radboud Umcn

Nijmegen, Netherlands

Erasmus MC

Rotterdam, Netherlands

Akershus Universitetssykehus

Nordbyhagen, Norway

Oslo University Hospital

Oslo, Norway

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, Poland

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

Bydgoszcz, Poland

Uniwersyteckie Centrum Kliniczne

Gdansk, Poland

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

Katowice, Poland

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

Krakow, Poland

Uniwersytecki Szpital Kliniczny nr 2 PUM w Szczecinie

Szczecin, Poland

Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji

Warsaw, Poland

Wojewodzki Szpital Specjalistyczny we Wroclawiu Osrodek Badawczo Rozwojowy

Wroclaw, Poland

Uls Coimbra - Hosp. Univ. Coimbra

Coimbra, Portugal

Uls Sao Jose - Hosp. Santa Marta

Lisbon, Portugal

Uls Santa Maria - Hosp. Pulido Valente

Lisbon, Portugal

Altay Regional Cardiological Dispensary

Barnaul, Russia

Chelyabinsk Regional Clinical Hospital

Chelyabinsk, Russia

State Autonomous HealthCare Institution 'Interregional Clinical Diagnostic Center'

Kazan', Russia

Scientific and Research Institution of Cardiovascular Diseases Complex Problems

Kemerovo, Russia

Moscow City Clinical Hospital No.51

Moscow, Russia

National Medical Research Center of Cardiology of MoH of Russian Federation

Moscow, Russia

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

Saint Petersburg, Russia

Samara Regional Clinical Cardiological Dispensary

Samara, Russia

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

Tyumen, Russia

Volgograd Regional Clinical Cardiology Center

Volgograd, Russia

King Faisal Specialist Hospital & Research Center

Riyadh, Saudi Arabia

King Fahad Medical City

Riyadh, Saudi Arabia

University Clinical Center of Serbia

Belgrade, Serbia

Institute for Pulmonary Disease of Vojvodina

Kamenitz, Serbia

National University Heart Centre, Singapore

Singapore, Singapore

National Heart Centre (NHC) Singapore

Singapore, Singapore

Narodny ustav srdcovych a cievnych chorob

Bratislava, Slovakia

The Eastern Slovakia Institute of Cardiovascular Diseases

Košice, Slovakia

Milpark Hospital

Johannesburg, South Africa

Dr Kalla

Lenasia, South Africa

Severance Hospital Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National University Hospital

Seoul, South Korea

Hosp Univ Vall D Hebron

Barcelona, Spain

Hosp. Del Mar

Barcelona, Spain

Hosp. Univ. 12 de Octubre

Madrid, Spain

Hosp. Univ. La Paz

Madrid, Spain

Hosp. Univ. Pta. de Hierro Majadahonda

Madrid, Spain

Hosp. Costa Del Sol

Málaga, Spain

Hosp Clinico Univ de Salamanca

Salamanca, Spain

Sahlgrenska Universitetsjukhuset

Gothenburg, Sweden

Skanes universitetssjukhus

Lund, Sweden

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Mackay Memorial Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Phramongkutklao Hospital and Medical College

Bangkok, Thailand

Ramathibodi Hospital Mahidol University

Bangkok, Thailand

Siriraj Hospital Mahidol University

Bangkok, Thailand

Maharaj Nakorn Chiang Mai hospital Faculty of Medicine

Chiang Mai, Thailand

Srinagarind Hospital, Khon Kaen University

Khon Kaen, Thailand

Songklanagarind hospital

Songkhla, Thailand

Adana City Hospital

Adana, Turkey (Türkiye)

Cukurova University Medical Faculty

Adana, Turkey (Türkiye)

Ankara Etlik Speciality Hospital

Ankara, Turkey (Türkiye)

Hacettepe University Medical Faculty

Ankara, Turkey (Türkiye)

Gazi University Medical Faculty

Ankara, Turkey (Türkiye)

Ankara Bilkent Sehir Hastanesi

Ankara, Turkey (Türkiye)

Akdeniz University Medical Faculty

Antalya, Turkey (Türkiye)

Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, Turkey (Türkiye)

Pamukkale Universitesi Tip Fakultesi Hastanesi

Denizli, Turkey (Türkiye)

Siyami Ersek Training and Research Hospital

Istanbul, Turkey (Türkiye)

Marmara University Medical Faculty

Istanbul, Turkey (Türkiye)

SBU Izmir Tepecik Egitim Ve Arastirma Hastanesi

Izmir, Turkey (Türkiye)

Ege Universitesi Tip Fakultesi Hastanesi

Izmir, Turkey (Türkiye)

Dokuz Eylul Universitesi Tip Fakültesi Hastanesi

Izmir, Turkey (Türkiye)

Kartal Kosuyolu Yuksek Ihtisas Egitim Ve Arastirma Hastanesi

Kartal Istanbul, Turkey (Türkiye)

Mersin University Medical Faculty

Mersin, Turkey (Türkiye)

CNE 'Cherkasy Regional Cardiological Center of Cherkasy Regional Council'

Cherkassy, Ukraine

Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council

Cherkasy, Ukraine

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

Dnipro, Ukraine

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

Kharkiv, Ukraine

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

Kyiv, Ukraine

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

Kyiv, Ukraine

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

Lviv, Ukraine

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

Ternopil, Ukraine

Royal Free Hospital

London, United Kingdom

Freeman Hospital

Newcastle upon Tyne, United Kingdom

Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital

Sheffield, United Kingdom

Hanoi Medical University Hospital

Hanoi, Vietnam

Cho Ray Hospital

Ho Chi Minh City, Vietnam

Tam Anh Hospital

Ho Chi Minh City, Vietnam

Tam Duc Heart Hospital

Ho Chi Minh City, Vietnam

University Medical Center Ho Chi Minh city

Ho Chi Minh City, Vietnam