165
Participants
Start Date
October 24, 2017
Primary Completion Date
August 28, 2024
Study Completion Date
November 30, 2025
Macitentan
Dispersible tablet; Oral use
Standard-of-care
Standard-of-care as per site's clinical practice which may comprise treatment with PAH non-specific treatment and/or up to two PAH-specific medications excluding macitentan and IV/SC prostanoids.
Gottsegen Gyorgy Orszagos Kardiologiai Intezet, Budapest
Makati Medical Center, Makati City
Children's Hospital at Westmead, Westmead
Royal Children's Hospital Melbourne - PIN, Parkville
Inkosi Albert Luthuli Central Hospital, Durban
Landes Frauen Und Kinderklinik Linz, Linz
Medizinische Universitat Wien, Linz
Lady Cilento Children's Hospital, South Brisbane
Medizinische Universität Graz, Graz
University of The Free State, Bloemfontein
Columbia University Medical Center - PIN, New York
Montefiore Medical Center, The Bronx
Hôpital de la Timone Enfants, Marseille
C.H. Regional Reina Sofia, Córdoba
Instituto Nacional de Cardiologia Dr. Ignacio Chavez, Mexico City
University of Virginia Health System, Charlottesville
Children's National Medical Center, Washington D.C.
Qingdao Women and Children's Hospital, Qingdao
Duke University Medical Center, Durham
East Carolina University, Greenville
Hospital General Universitario Gregorio Marañon, Madrid
Hospital Universitario Ramon y Cajal, Madrid
Hospital Universitario 12 de Octubre, Madrid
Hospital Universitario La Paz, Madrid
Hôpital Des Enfants, Toulouse
Rambam Medical Center - PPDS, Haifa
Hôpital Haut-Lévêque - Hôpital cardiologique, Pessac
Nationwide Children's Hospital, Columbus
University Hospitals Cleveland Medical Center, Rainbow Babies and Childrens Hospital, Cleveland
CICUM San Miguel, Guadalajara
Cincinnati Children's Hospital Medical Center, Cincinnati
Hospital Universitari i Politecnic La Fe de Valencia, Valencia
Riley Hospital For Children, Indianapolis
Detroit Medical Center, Detroit
MI Dnipropetrovsk Specialized Clin. Med. Center of Mother and Child n.a. prof. M.F. Rudnev of DRC, Dnipro
Schneider Children's Medical Center of Israel - PIN, Petah Tikva
Maharaj Nakorn Chiang Mai Chiang Mai University, Chiang Mai
Institut Jantung Negara, Kuala Lumpur
Chaim Sheba Medical Center, Ramat Gan
Operadora de Hospitales Angeles SA de CV Hospital Angeles Lomas, México
Childrens Hospital of Wisconsin, Milwaukee
Mayo Clinic - PPDS, Rochester
University Malaya Medical Centre, Kuala Lumpur
Municipal Institution of Health Care Regional Children's Clinical Hospital, Kharkiv
Unidad de Investigación Clínica En Medicina SC, Monterrey
Groupe Hospitalier Necker Enfants Malades, Paris
Childrens Hospital Colorado, Aurora
Primary Children's Medical Center, Salt Lake City
Phoenix Childrens Hospital, Phoenix
Children's Heart Center, Las Vegas
UCLA Children's Heart Center, Los Angeles
Hanoi Heart Hospital, Hanoi
Hanoi Medical University Hospital, Hanoi
Beijing Anzhen Hospital of The Capital University of Medical Sciences, Beijing
GBUZ Children's Hospital named after Bashlyaeva Z.A. Moscow, Moscow
Russian National Research Medical University n.a. N.I.Pirogov, Moscow
Saint Petersburg State Pediatric Medical Academy, Saint Petersburg
Childrens Hospital of Shanghai, Shanghai
Shanghai Children's Medical Center, Shanghai
Fundacion Santa Fe de Bogota, Bogotá
Bashkiria State Medical University, Ufa
Clinical Hospital №1, Tyumen
Novosibirsk Research Institue of Blood Circulation Pathology n.a. E.N. Meshalkin, Novosibirsk
Research Institute of Complex Cardiovascular Pathology, Kemerovo
Children's Hospital 1, Ho Chi Minh City
Tam Duc Hospital, Ho Chi Minh City
Centro Medico Imbanaco de Cali SA, Santiago de Cali
UCSF Medical Center, San Francisco
Boston Children's Hospital, Boston
Irmandade Da Santa Casa de Misericórdia de São Paulo, São Paulo
Sainte Justine Hospital, Montreal
Stollery Children's Hospital, Toronto
HUS Uusi lastensairaala, Helsinki
Instituto Nacional de Pediatría, Mexico City
Philippine Heart Center, Quezon City
Szpital Kliniczny im. Karola Jonschera Uniwersytetu Medycznego im. Karola Marcinkowskiego w Poznaniu, Poznan
Instytut Pomnik - Centrum Zdrowia Dziecka, Warsaw
Wojewodzki Szpital Specjalistyczny we Wroclawiu Osrodek Badawczo-Rozwojowy, Wroclaw
Centro Hospitalar de Lisboa Ocidental, EPE - Hospital de Santa Cruz, Carnaxide
Centro Hospitalar E Universitário de Coimbra EPE, Coimbra
Hospital Santa Marta, Lisbon
Centro Hospitalar de Sao Joao EPE, Porto
Seoul National University Hospital, Seoul
Severance Hospital Yonsei University Health System - PPDS, Seoul
Hospital Universitario Vall d'Hebron - PPDS, Barcelona
MI Scientific Practical Medical Center for Children Cardiology and Cardiosurgery of MOH of Ukraine, Kyiv
Lead Sponsor
Actelion
INDUSTRY