187
Participants
Start Date
July 29, 2019
Primary Completion Date
August 23, 2022
Study Completion Date
September 27, 2024
FDC macitentan/tadalafil
Film-coated tablet with 10 mg macitentan and 40 mg tadalafil, to be administered orally once daily.
Macitentan 10 mg
Film-coated tablet with 10 mg macitentan, to be administered orally once daily.
Tadalafil 40 mg
Film-coated tablet with 40 mg tadalafil (2 x 20 mg tablets), to be administered orally once daily.
Placebo FDC
Matching placebo not containing any active substance but otherwise identical in appearance to the respective active drug tablet, to be administered orally once daily.
Placebo macitentan
Matching placebo not containing any active substance but otherwise identical in appearance to the respective active drug tablet, to be administered orally once daily.
Placebo tadalafil
Matching placebo not containing any active substance but otherwise identical in appearance to the respective active drug tablet, to be administered orally once daily.
Taipei Veterans General Hospital, Taipei
Chang-Gung Memorial Hospital, LinKou Branch, Taoyuan District
National Cheng Kung University Hospital, Tainan City
Kaohsiung Veterans General Hospital, Kaohsiung City
Semmelweis Egyetem,Pulmonológiai Klinika, Budapest
Gottsegen György Országos Kardiológiai Intézet, Felnőtt kardiológiai osztály, Budapest
National Heart Hospital, Sofia
University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD, Sofia
Dr Kalla, Lenasia
Abdullah, IA, Durban
Core Research Group, Milton
Royal Adelaide Hospital, Adelaide
Hacettepe University Medical Faculty, Ankara
Ankara University Medical Faculty, Ankara
Szegedi Tudomanyegyetem, Szeged
Pulmonary Arterial Hypertension Clinic, Hobart
Pecsi Tudomanyegyetem Klinikai Kozpont, Pécs
Hosp Univ Vall D Hebron, Barcelona
National Taiwan University Hospital, Taipei
Mackay Memorial Hospital, Taipei
Instituto Nacional de Cardiologia Dr. Ignacio Chavez, México
University of Pittsburgh Medical Center, Pittsburgh
Bursa Yuksek Ihtisas Training and Research Hospital, Bursa
Universitat Greifswald, Greifswald
Thomas Jefferson University Hospital, Philadelphia
Azienda Ospedaliera San Gerardo, Monza
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Milan
Universitaetsklinikum Hamburg Eppendorf, Hamburg
Cardiologia c/o Spedali Civili, Brescia
WVU Health Sciences Center, Morgantown
Kardiologische Praxis Papenburg, Papenburg
IRCCS Policlinico San Matteo, Università degli studi di Pavi, Pavia
The University of North Carolina at Chapel Hill, Chapel Hill
Pitt County Memorial Hospital d/b/a Vidant Medical Center, Greenville
Hosp. Univ. Ramon Y Cajal, Madrid
Hosp Univ Fund Jimenez Diaz, Madrid
Hosp. Univ. La Paz, Madrid
WellStar Health System, Marietta
Piedmont Healthcare, Atlanta
Mersin University Medical Faculty, Mersin
Istanbul University - Cerrahpasa Cardiology Institution, Istanbul
Istanbul University Cerrahpasa Medical Faculty, Istanbul
Kartal Kosuyolu Yuksek Ihtisas Egitim Ve Arastirma Hastanesi, Kartal Istanbul
Marmara University Medical Faculty, Istanbul
Ege University School of Medicine, Izmir
Dokuz Eylul University Hospital, Izmir
Universitaetsklinikum Giessen, Giessen
Hosp Clinico Univ de Salamanca, Salamanca
Hosp. Univ. Marques de Valdecilla, Santander
Konya Selcuk University Medical Faculty, Konya
St. Elizabeth Hospital Mercy Bon Secors, Youngstown
Hosp. Virgen de La Salud, Toledo
University of Cincinnati, Cincinnati
Hosp. Gral. Univ. Valencia, Valencia
Sparrow Clinical Research Institute, Lansing
Institut Jantung Negara (National Heart Institute), Kuala Lumpur
University of Iowa Hospitals and Clinics, Iowa City
Universitatsklinikum Bonn, Bonn
Medical College of Wisconsin Froedtert Hospital, Milwaukee
University of Wisconsin At Madison, Madison
Minneapolis Heart Institute Foundation, Minneapolis
Sanford Health, Sioux Falls
Sanford Health, Fargo
OSF HealthCare Cardiovascular Institute, Peoria
Washington University School Of Medicine, St Louis
Unidad de Investigacion Clinica en Medicina S.C. (UDICEM), Monterrey
Thoraxklinik am Universitatsklinikum Heidelberg, Heidelberg
Azienda Ospedaliero Universitaria Consorziale Policlinico di Bari, Bari
Baylor Scott White - Plano, Plano
University of Texas Southwestern Medical Center, Dallas
VA Sierra Nevada Health Care System, Reno
University of Southern California, Los Angeles
Providence Medical Foundation, Fullerton
Universitaetsklinikum Regensburg, Regensburg
Sarawak Heart Center, Kuching
Klinikum Würzburg Mitte gGmbH Standort Missioklinik, Würzburg
Legacy Hospital, Portland
Oregon Health and Science University, Portland
Beijing Anzhen Hospital, Beijing
The General Hospital of Northern Theater Command, Shenyang
National Medical Research Center of Cardiology of MoH of Russian Federation, Moscow
GU Moscow Regional Research Clinical Institute n.a. M.F.Vla, Moscva
National medical Research Center n.a. V.A.Almazov of MoH of Russian Federation, Saint Petersburg
Shanghai Pulmonary Hospital, Shanghai
Tianjin Medical University General Hospital, Tianjin
The Second Xiangya Hospital of Central South Hospital, Changsha
Samara Regional Clinical Cardiological Dispensary, Samara
The First Affiliated Hospital of Guangzhou Medical University, Guangzhou
Scientific and Research Institution of Cardiovascular Diseases Complex Problems, Kemerovo
Altay Regional Cardiological Dispensary, Barnaul
The First Affiliated Hospital of Xian Jiaotong University, Xi'an
Norton Healthcare, Louisville
Universidade Federal De Minas Gerais - Hospital das Clínicas, Belo Horizonte
Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa, Belo Horizonte
Fundacao para o Desenvolvimento Medico Hospitalar (UNESP Botucatu), Botucatu
Secretaria da Saude do Estado do Ceara - Hospital Doutor Carlos Alberto Studart Gomes, Fortaleza
Universidade Federal de Goias - Hospital das Clinicas da UFG, Goiânia
Hospital das Clinicas de Porto Alegre, Porto Alegre
Irmandade Santa Casa de Misericordia de Porto Alegre, Porto Alegre
Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS, Porto Alegre
SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo, São Paulo
Hospital Das Clinicas Da Faculdade De Medicina Da USP, São Paulo
Alberta Health Services, Calgary
University of Alberta, Edmonton
Vancouver General Hospital, Vancouver
London Health Sciences Centre, London
Jiangsu Province Hospital, Nanjing
General University Hospital II.department of Internal Medicine-cardiology and angiology, Prague
Universitatsklinikum Carl Gustav Carus Dresden, Dresden
Ospedale San Francesco, Nuoro
Policlinico Umberto I, Roma
The University of Tokyo Hospital, Bunkyō City
Chiba University Hospital, Chiba
Kyushu University Hospital, Fukuoka
Fukushima Medical University Hospital, Fukushima
Gunma University Hospital, Gunma
Kure Kyosai Hospital, Hiroshima
Tokai University Hospital, Isehara
Kagoshima University Hospital, Kagoshima
Kanazawa University Hospital, Kanazawa
Kobe University Hospital, Kobe
Kumamoto University Hospital, Kumamoto
Kurume University Hospital, Kurume
University Hospital Kyoto Prefectural University of Medicine, Kyoto
Kyoto University Hospital, Kyoto
Shinshu University Hospital, Matsumoto
Kyorin University Hospital, Mitaka
Nagasaki University Hospital, Nagasaki
Okayama University Hospital, Okayama
National Hospital Organization Okayama Medical Center, Okayama
Sapporo Medical University Hospital, Sapporo
Hokkaido University Hospital, Sapporo
Tohoku University Hospital, Sendai
National Cerebral and Cardiovascular Center, Suita-Shi
Juntendo University Hospital, Tokyo
Mie University Hospital, Tsu
University of Tsukuba Hospital, Tsukuba
Klinika Kardiologii Z Oddzialem Intensywnego Nadzoru Kardiologicznego UM W Bialymstoku, Bialystok
Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy, Klinika Kardiologii, Bydgoszcz
Uniwersyteckie Centrum Kliniczne, Gdansk
GCM SUM I Oddzial Kardiologii, Katowice
Oddzial Kardiologii Wojewodzki Szpital Specjalistyczny im W Bieganskiego, Lodz
Wojewodzki Szpital Specjalistyczny im. Stefana Kardynala Wyszynskiego SPZOZ, Oddzial Kardiologii, Lublin
ECZ Otwock Klinika Kardiologii Klinika Krazenia Plucnego Chorob Zakrzepowo Zatorowych i Kardiologii, Otwock
Uniwersytecki Szpital Kliniczny nr 2 PUM Klinika Kardiologii, Szczecin
Wojewodzki Szpital Specjalistyczny Oddzial Kardiologiczny, Wroclaw
Hosp Clinic de Barcelona, Barcelona
Cukurova University Medical Faculty, Adana
Lead Sponsor
Actelion
INDUSTRY