Clinical trial NCT04273945: Outcome Study Assessing a 75 Milligrams (mg) Dose of Macitentan in Patients With Pulmonary Arterial Hypertension
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Pulmonary Arterial Hypertension
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2020-02-18
Enrollment: 935
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Double-blind Treatment Period: Time to First Clinical Events Committee (CEC)-adjudicated Morbidity or Mortality (M/M) Events
timeFrame: Up to 4 years
Secondary outcomes:
measure: Double-blind Treatment Period: Change From Baseline to Week 24 in 6MWD
timeFrame: Baseline up to Week 24
measure: 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
timeFrame: Up to 4 years
measure: Double-blind Treatment Period: Change From Baseline to Week 24 in PAH Symptoms Based on PAH-SYMPACT Questionnaire- Cardiopulmonary Symptom Domain Score
timeFrame: Baseline up to Week 24
measure: Double-blind Treatment Period: Change From Baseline to Week 24 in PAH Symptoms Based on PAH-SYMPACT Questionnaire- Cardiovascular Symptom Domain Score
timeFrame: Baseline up to Week 24
measure: Double-blind Treatment Period: Time to Death Occurring Between Randomization and End of Double-blind Treatment (EDBT)
timeFrame: Up to 4 years
measure: Treatment Extension Period: Time to Death Occurring Between Randomization and End of Study (EOS)
timeFrame: Up to 6 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
city: Scottsdale
country: United States
facility: Arizona Pulmonary Specialists, Ltd
state: Arizona
city: La Jolla
country: United States
facility: Scripps Memorial Hospital
state: California
city: Los Angeles
country: United States
facility: USC Keck
state: California
city: Santa Barbara
country: United States
facility: Jeffrey S. Sager, MD Medical Corporation
state: California
city: Torrance
country: United States
facility: Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
state: California
city: Denver
country: United States
facility: National Jewish Health
state: Colorado
city: Weston
country: United States
facility: Cleveland Clinic
state: Florida
city: Atlanta
country: United States
facility: Piedmont Healthcare
state: Georgia
city: Atlanta
country: United States
facility: Northside Hospital
state: Georgia
city: Oak Lawn
country: United States
facility: Advocate Christ Medical Center
state: Illinois
city: Indianapolis
country: United States
facility: Indiana University
state: Indiana
city: Indianapolis
country: United States
facility: St. Vincent Medical Group, Inc.
state: Indiana
city: Iowa City
country: United States
facility: University Of Iowa - Hospitals & Clinics
state: Iowa
city: Louisville
country: United States
facility: Norton Pulmonary Specialists
state: Kentucky
city: New Orleans
country: United States
facility: Louisiana State University
state: Louisiana
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Troy
country: United States
facility: Troy Beaumont
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School Of Medicine
state: Missouri
city: Saint Louis
country: United States
facility: Saint Louis University Academic Pavillion
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Reno
country: United States
facility: Reno Heart Institute
state: Nevada
city: Mineola
country: United States
facility: Winthrop University Hospital
state: New York
city: New York
country: United States
facility: Mount Sinai
state: New York
city: New York
country: United States
facility: Columbia University
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Medical Center
state: New York
city: Durham
country: United States
facility: Duke
state: North Carolina
city: Cincinnati
country: United States
facility: Lindner Clinical Trial Center/Christ Hospital
state: Ohio
city: Oklahoma City
country: United States
facility: Integris Baptist Office
state: Oklahoma
city: Portland
country: United States
facility: The Oregon Clinic
state: Oregon
city: Portland
country: United States
facility: Oregon Pulmonary Clinic
state: Oregon
city: Portland
country: United States
facility: Oregon Health And Science University
state: Oregon
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Allegheny General Hospital of Research
state: Pennsylvania
city: Wynnewood
country: United States
facility: Lankenau Medical Center
state: Pennsylvania
city: Anderson
country: United States
facility: AnMed Health
state: South Carolina
city: Dallas
country: United States
facility: UT Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine (BCM) - Baylor Heart Clinic
state: Texas
city: Plano
country: United States
facility: Baylor Scott White - Plano
state: Texas
city: San Antonio
country: United States
facility: San Antonio Methodist TX Transplant Physicians Group
state: Texas
city: Burlington
country: United States
facility: The Robert Larner, M.D. College of Medicine at The University of Vermont
state: Vermont
city: Madison
country: United States
facility: University of Wisconsin Hospital and Clinics
state: Wisconsin
city: Milwaukee
country: United States
facility: Medical College Of Wisconsin
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Sanatorio de la Trinidad Mitre
city: C.a.b.a.
country: Argentina
facility: Sanatorio Guemes
city: Caba
country: Argentina
facility: Hospital Italiano de Buenos Aires
city: Caba
country: Argentina
facility: Sanatorio Ramon Cereijo
city: Caba
country: Argentina
facility: Centro Médico Dra. De Salvo
city: Corrientes
country: Argentina
facility: Instituto de Cardiologia de Corrientes
city: Rosario
country: Argentina
facility: Instituto Medico de La Fundacion Estudios Clinicos
city: Rosario
country: Argentina
facility: Instituto Cardiovascular de Rosario
city: Bedford Park
country: Australia
facility: Flinders Medical Centre
city: Camperdown
country: Australia
facility: Royal Prince Alfred Hospital
city: Chermside
country: Australia
facility: The Prince Charles Hospital
city: Darlinghurst
country: Australia
facility: St Vincent's hospital
city: Hobart
country: Australia
facility: Royal Hobart Hospital
city: Murdoch
country: Australia
facility: Fiona Stanley Hospital
city: Westmead
country: Australia
facility: Westmead Hospital
city: Graz
country: Austria
facility: LKH-Univ. Klinikum Graz
city: Linz
country: Austria
facility: Ordensklinikum Linz GmbH Elisabethinen
city: Vienna
country: Austria
facility: Medical University Vienna
city: Minsk
country: Belarus
facility: The Republican Scientific-Practical Center ''Cardiology''
city: Minsk
country: Belarus
facility: Minsk Regional Clinical Hospital
city: Brussels
country: Belgium
facility: ULB Hôpital Erasme
city: Leuven
country: Belgium
facility: UZ Leuven
city: Belo Horizonte
country: Brazil
facility: Universidade Federal De Minas Gerais - Hospital das Clínicas
city: Belo Horizonte
country: Brazil
facility: Instituto das Pequenas Missionárias de Maria Imaculada - Hospital Madre Teresa
city: Brasilia
country: Brazil
facility: Empresa Brasileira de Servicos Hospitalares-EBSERH-Hospital Universitario de Brasilia
city: Campina Grande do Sul
country: Brazil
facility: Sociedade Hospitalar Angelina Caron - Hospital Angelina Caron
city: Curitiba
country: Brazil
facility: Ceti - Centro de Estudos Em Terapias Inovadoras
city: Florianopolis
country: Brazil
facility: Ynova Pesquisa Clinica
city: Goiania
country: Brazil
facility: Universidade Federal de Goias - Hospital das Clinicas da UFG
city: Porto Alegre
country: Brazil
facility: Hospital das Clinicas de Porto Alegre
city: Porto Alegre
country: Brazil
facility: Uniao Brasileira de Educacao e Assistencia Hospital Sao Lucas da PUCRS
city: Recife
country: Brazil
facility: Instituto de Medicina Integral Professor Fernando Figueira
city: Santo Andre
country: Brazil
facility: Fundacao do ABC Centro Universitario FMABC
city: Sao Paulo
country: Brazil
facility: Secretaria de Estado da Saude Instituto Dante Pazzanese de Cardiologia
city: Sao Paulo
country: Brazil
facility: Hospital Das Clinicas Da Faculdade De Medicina Da USP
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital For Active Treatment National Cardiology Hospital, Ead
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatment- UMHAT Sveta Anna AD
city: Hamilton
country: Canada
facility: St. Joseph's Health Centre
state: Ontario
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: University Health Network - Toronto General Hospital
state: Ontario
city: Montreal
country: Canada
facility: Jewish General Hospital
state: Quebec
city: Beijing
country: China
facility: Beijing Chaoyang Hospital
city: Beijing
country: China
facility: Beijing Anzhen Hospital
city: Beijing
country: China
facility: Peking Union Medical College Hospital
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South Hospital
city: Chengdu
country: China
facility: West China Hospital Sichuan University
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
city: Guangzhou
country: China
facility: The First Affiliated Hospital of Guangzhou Medical University
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital
city: Shanghai
country: China
facility: Renji Hospital
city: Shanghai
country: China
facility: Zhongshan Hospital Fudan University
city: Shenyang
country: China
facility: The General Hospital of Northern Theater Command
city: Shenyang
country: China
facility: Shengjing Hospital Of China Medical University
city: Tianjin
country: China
facility: Tianjin Medical University General Hospital
city: Xi'An
country: China
facility: The First Affiliated Hospital of Xian Jiaotong University
city: Bogota
country: Colombia
facility: Fundacion Neumologica Colombiana
city: Bucaramanga - Piedecuesta - Valle De Menzuli
country: Colombia
facility: Fundacion Cardiovascular de Colombia
city: Cali
country: Colombia
facility: Clínica Imbanaco S.A.S.
city: Medellin
country: Colombia
facility: Centro Cardiovascular Colombiano Clínica Santa María
city: Soledad
country: Colombia
facility: Hospital Universidad del Norte
city: Praha 2
country: Czechia
facility: General University Hospital II.department of Internal Medicine-cardiology and angiology
city: Arhus
country: Denmark
facility: Århus Universitetshospital, Skejby, Hjertemedicinsk Afdeling B
city: Brest
country: France
facility: CHU de Brest - Hopital de la Cavale Blanche
city: Caen Cedex
country: France
facility: Hôpital Côte de Nacre
city: Le Kremlin Bicêtre cedex
country: France
facility: Hopital Bicetre Aphp Hopitaux Universitaires Paris Sud
city: Lille Cedex
country: France
facility: CHRU de Lille Hopital Claude Huriez
city: Marseille Cedex 20
country: France
facility: Aphm - Hopital Nord
city: Nice
country: France
facility: Centre Hospitalier Universitaire - de Nice - Hopital Pasteur
city: St Priest en Jarez Cedex
country: France
facility: CHU Saint Etienne Hopital Nord
city: Toulouse Cedex 9
country: France
facility: Hopital Larrey CHU de Toulouse
city: Bad Oeynhausen
country: Germany
facility: Ruhr Universitat Bochum Diabeteszentrum
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: München
country: Germany
facility: Medizinische Klinik und Poliklinik V Klinikum Grosshadern der LMU
city: Regensburg
country: Germany
facility: Universitaetsklinikum Regensburg
city: Alexandroupoli
country: Greece
facility: University Hospital of Alexandroupolis
city: Athens
country: Greece
facility: Alexandra General Hospital of Athens
city: Larisa
country: Greece
facility: University Hospital Of Larissa
city: Thessaloniki
country: Greece
facility: Ahepa University General Hospital of Thessaloniki
city: Budapest
country: Hungary
facility: Semmelweis Egyetem,Pulmonológiai Klinika
city: Budapest
country: Hungary
facility: Gottsegen Gyorgy Orszagos Kardiovaszkularis Intezet Felnott kardiologiai osztaly
city: Pecs
country: Hungary
facility: Pecsi Tudomanyegyetem Altalanos Orvostudomanyi Kar
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem, Általános Orvostudományi Kar, Családorvosi Intézet és rendelő
city: Ahmedabad
country: India
facility: NHL Medical College (SVP Hospital IMSR)
city: Ahmedabad
country: India
facility: Cims Hospital
city: Bangalore
country: India
facility: Narayana Hrudayalaya Limited
city: Chengalpetu
country: India
facility: SRM Medical College Hospital & Research Centre
city: Coimbatore
country: India
facility: Govindaswamy Kuppuswamy Naidu Memorial Hospital
city: Durgapur
country: India
facility: HealthWorld Hospitals
city: Hyderabad
country: India
facility: Renova Century Hospitals
city: Hyderbad
country: India
facility: Care Hospitals
city: Kolkata
country: India
facility: Rabindranath Tagore International Institute of Cardiac Sciences
city: New Delhi
country: India
facility: GB Pant Institute of Post Graduate Medical Education & Research
city: New Delhi
country: India
facility: Sir Ganga Ram Hospital
city: Pondicherry
country: India
facility: Jawaharlal Institute of Postgraduate Medical Education and Research
city: Surat
country: India
facility: B.D. Mehta Mahavir Heart Institute
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tel-Hashomer
country: Israel
facility: The Chaim Sheba Medical Center
city: Zerifin
country: Israel
facility: Yitzhak Shamir Medical Center
city: Milano
country: Italy
facility: ASST Grande Ospedale Metropolitano Niguarda
city: Modena
country: Italy
facility: AOU Di Modena Policlinico Di Modena
city: Nuoro
country: Italy
facility: Ospedale San Francesco
city: Pavia
country: Italy
facility: Fondazione IRCCS Policlinico San Matteo
city: Pisa
country: Italy
facility: Fondazione Toscana Gabriele Monasterio CNR
city: Roma
country: Italy
facility: Policlinico Gemelli Universita Cattolica
city: Bunkyo
country: Japan
facility: The University of Tokyo Hospital
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
city: Hiroshima
country: Japan
facility: Kure Kyosai Hospital
city: Kagoshima City
country: Japan
facility: Kagoshima University Hospital
city: Kanagawa
country: Japan
facility: St Marianna University Hospital
city: Kanazawa
country: Japan
facility: Kanazawa University Hospital
city: Kobe
country: Japan
facility: Kobe University Hospital
city: Kurume
country: Japan
facility: Kurume University Hospital
city: Kyoto
country: Japan
facility: University Hospital Kyoto Prefectural University of Medicine
city: Kyoto
country: Japan
facility: Kyoto University Hospital
city: Matsumoto
country: Japan
facility: Shinshu University Hospital
city: Nagasaki-shi
country: Japan
facility: Nagasaki University Hospital
city: Nagoya
country: Japan
facility: Nagoya University Hospital
city: Nagoya
country: Japan
facility: Nagoya City University Hospital
city: Niigata
country: Japan
facility: Niigata University Medical And Dental Hospital
city: Okayama
country: Japan
facility: Okayama University Hospital
city: Okayama
country: Japan
facility: National Hospital Organization Okayama Medical Center
city: Sapporo-shi
country: Japan
facility: Hokkaido University Hospital
city: Sapporo
country: Japan
facility: Sapporo Medical University Hospital
city: Suita-Shi
country: Japan
facility: National Cerebral and Cardiovascular Center
city: Tokyo
country: Japan
facility: Juntendo University Hospital
city: Toyoake
country: Japan
facility: Fujita Health University Hospital
city: Tsukuba City
country: Japan
facility: University of Tsukuba Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: George Town
country: Malaysia
facility: Hospital Pulau Pinang
city: Kajang
country: Malaysia
facility: Hospital Serdang
city: Kota Samarahan
country: Malaysia
facility: Sarawak Heart Center
city: Kuala Lumpur
country: Malaysia
facility: Institut Jantung Negara (National Heart Institute)
city: Ciudad De México
country: Mexico
facility: Instituto Nacional de Cardiologia Dr. Ignacio Chavez
city: Guadalajara
country: Mexico
facility: Consultorio Privado del Dr. Gabriel Arturo Ramos Lopez
city: Mexico
country: Mexico
facility: Operadora de Hospitales Angeles SA de CV Hospital Angeles Lomas
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr Jose Eleuterio Gonzalez
city: Monterrey
country: Mexico
facility: Unidad de Investigacion Clinica en Medicina S.C. (UDICEM)
city: Morelia
country: Mexico
facility: Centro de Investigacion Clinica Chapultepec
city: Amsterdam
country: Netherlands
facility: VUMC Amsterdam
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis Nieuwegein
city: Nijmegen
country: Netherlands
facility: Radboud Umcn
city: Rotterdam
country: Netherlands
facility: Erasmus MC
city: Nordbyhagen
country: Norway
facility: Akershus Universitetssykehus
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Bialystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 im dr Jana Biziela w Bydgoszczy, Klinika Kardiologii
city: Gdansk
country: Poland
facility: Uniwersyteckie Centrum Kliniczne
city: Katowice
country: Poland
facility: SPSK nr 7 SUM w Katowicach Gornoslaskie Centrum Medyczne im Prof Leszka Gieca
city: Krakow
country: Poland
facility: Krakowski Szpital Specjalityczny im Jana Pawla II Oddzial Kliniczny Chorob Serca i Naczyn
city: Szczecin
country: Poland
facility: Uniwersytecki Szpital Kliniczny nr 2 PUM w Szczecinie
city: Warszawa
country: Poland
facility: Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
city: Wroclaw
country: Poland
facility: Wojewodzki Szpital Specjalistyczny we Wroclawiu Osrodek Badawczo Rozwojowy
city: Coimbra
country: Portugal
facility: Uls Coimbra - Hosp. Univ. Coimbra
city: Lisboa
country: Portugal
facility: Uls Santa Maria - Hosp. Pulido Valente
city: Lisbon
country: Portugal
facility: Uls Sao Jose - Hosp. Santa Marta
city: Barnaul
country: Russian Federation
facility: Altay Regional Cardiological Dispensary
city: Chelyabinsk
country: Russian Federation
facility: Chelyabinsk Regional Clinical Hospital
city: Kazan
country: Russian Federation
facility: State Autonomous HealthCare Institution 'Interregional Clinical Diagnostic Center'
city: Kemerovo
country: Russian Federation
facility: Scientific and Research Institution of Cardiovascular Diseases Complex Problems
city: Moscow
country: Russian Federation
facility: Moscow City Clinical Hospital No.51
city: Moscow
country: Russian Federation
facility: National Medical Research Center of Cardiology of MoH of Russian Federation
city: Saint-Petersburg
country: Russian Federation
facility: National medical Research Center n.a. V.A.Almazov of MoH of Russian Federation
city: Samara
country: Russian Federation
facility: Samara Regional Clinical Cardiological Dispensary
city: Tumen
country: Russian Federation
facility: State Autonomous Healthcare Institution of Tyumen Region 'Scientific and Practical Medical Center'
city: Volgograd
country: Russian Federation
facility: Volgograd Regional Clinical Cardiology Center
city: Riyadh
country: Saudi Arabia
facility: King Faisal Specialist Hospital & Research Center
city: Riyadh
country: Saudi Arabia
facility: King Fahad Medical City
city: Belgrade
country: Serbia
facility: University Clinical Center of Serbia
city: Sremska Kamenica
country: Serbia
facility: Institute for Pulmonary Disease of Vojvodina
city: Singapore
country: Singapore
facility: National University Heart Centre, Singapore
city: Singapore
country: Singapore
facility: National Heart Centre (NHC) Singapore
city: Bratislava
country: Slovakia
facility: Narodny ustav srdcovych a cievnych chorob
city: Kosice
country: Slovakia
facility: The Eastern Slovakia Institute of Cardiovascular Diseases
city: Johannesburg
country: South Africa
facility: Milpark Hospital
city: Lenasia
country: South Africa
facility: Dr Kalla
city: Barcelona
country: Spain
facility: Hosp Univ Vall D Hebron
city: Barcelona
country: Spain
facility: Hosp. Del Mar
city: Madrid
country: Spain
facility: Hosp. Univ. 12 de Octubre
city: Madrid
country: Spain
facility: Hosp. Univ. La Paz
city: Madrid
country: Spain
facility: Hosp. Univ. Pta. de Hierro Majadahonda
city: Malaga
country: Spain
facility: Hosp. Costa Del Sol
city: Salamanca
country: Spain
facility: Hosp Clinico Univ de Salamanca
city: Goteborg
country: Sweden
facility: Sahlgrenska Universitetsjukhuset
city: Lund
country: Sweden
facility: Skanes universitetssjukhus
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: Taipei Veterans General Hospital
city: Bangkok
country: Thailand
facility: Phramongkutklao Hospital and Medical College
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital Mahidol University
city: Bangkok
country: Thailand
facility: Siriraj Hospital Mahidol University
city: Chiang Mai
country: Thailand
facility: Maharaj Nakorn Chiang Mai hospital Faculty of Medicine
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital, Khon Kaen University
city: Songkhla
country: Thailand
facility: Songklanagarind hospital
city: Adana
country: Turkey
facility: Adana City Hospital
city: Adana
country: Turkey
facility: Cukurova University Medical Faculty
city: Ankara
country: Turkey
facility: Ankara Etlik Speciality Hospital
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty
city: Ankara
country: Turkey
facility: Ankara Bilkent Sehir Hastanesi
city: Antalya
country: Turkey
facility: Akdeniz University Medical Faculty
city: Bursa
country: Turkey
facility: Bursa Yuksek Ihtisas Training and Research Hospital
city: Denizli
country: Turkey
facility: Pamukkale University Medical Faculty
city: Istanbul
country: Turkey
facility: Siyami Ersek Training and Research Hospital
city: Istanbul
country: Turkey
facility: Marmara University Medical Faculty
city: Izmir
country: Turkey
facility: Ege University Medical Faculty
city: Izmir
country: Turkey
facility: Tepecik Training and Research Hospital
city: Izmir
country: Turkey
facility: Dokuz Eylul University Medical Faculty
city: Kartal Istanbul
country: Turkey
facility: Kartal Kosuyolu Yuksek Ihtisas Egitim Ve Arastirma Hastanesi
city: Mersin
country: Turkey
facility: Mersin University Medical Faculty
city: Cherkassy
country: Ukraine
facility: CNE 'Cherkasy Regional Cardiological Center of Cherkasy Regional Council'
city: Cherkasy
country: Ukraine
facility: Communal Noncommercial Enterprise Cherkasy Regional Hospital of Cherkasy Regional Council
city: Dnipro
country: Ukraine
facility: MI 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiac Surgery'
city: Kharkiv
country: Ukraine
facility: CNE' City Clinical Hospital #8' of Kharkiv City Council
city: Kyiv
country: Ukraine
facility: SI National Scientific Center Institute of Cardiology of M.D. Strazhesko of NAMS of Ukraine
city: Kyiv
country: Ukraine
facility: State Institute Of Phthisiology And Pulmonology N.A. F.G. Yanovskiy Of Ams Ukraine
city: Lviv
country: Ukraine
facility: Communal Noncommercial Enterprise of Lviv Regional Council 'Lviv Regional Clinical Hospital'
city: Ternopil
country: Ukraine
facility: Municipal Non-commercial Enterprise Ternopil University Hospital of Ternopil Regional Council
city: London
country: United Kingdom
facility: Royal Free Hospital
city: Newcastle Upon Tyne
country: United Kingdom
facility: Freeman Hospital
city: Sheffield
country: United Kingdom
facility: Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital
city: Hanoi
country: Vietnam
facility: Hanoi Medical University Hospital
city: Ho Chi Minh
country: Vietnam
facility: Cho Ray Hospital
city: Ho Chi Minh
country: Vietnam
facility: Tam Anh Hospital
city: Ho Chi Minh
country: Vietnam
facility: Tam Duc Heart Hospital
city: Ho Chi Minh
country: Vietnam
facility: University Medical Center Ho Chi Minh city
Study officials:
affiliation: Actelion
name: Actelion Clinical Trials
role: STUDY_DIRECTOR
References: