A Study to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension

PHASE3TerminatedINTERVENTIONAL
Enrollment

127

Participants

Timeline

Start Date

July 7, 2020

Primary Completion Date

December 21, 2023

Study Completion Date

December 21, 2023

Conditions
Chronic Thromboembolic Pulmonary Hypertension
Interventions
DRUG

Macitentan

Participants will receive Macitentan film-coated tablets orally od.

DRUG

Placebo

Participant will receive matching placebo tablets orally od.

Trial Locations (168)

112

Taipei Veterans General Hospital, Taipei

333

Chang-Gung Memorial Hospital, LinKou Branch, Taoyuan District

813

Kaohsiung Veterans General Hospital, Kaohsiung City

1090

Medizinische Universitaet Wien, Vienna

1096

Gottsegen Gyorgy Orszagos Kardiovaszkularis Intezet Felnott kardiologiai osztaly, Budapest

1606

Military Medical Academy, Sofia

1750

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

2010

St Vincent's hospital, Darlinghurst

4020

Ordensklinikum Linz GmbH Elisabethinen, Linz

4032

Queensland Lung Transplant Service, Chermside

6720

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

8036

LKH-Univ. Klinikum Graz, Graz

8200

Århus Universitetshospital, Skejby, Hjertemedicinsk Afdeling B, Aarhus N

10002

National Taiwan University Hospital, Taipei

10126

A.O.U. Città della Salute e della Scienza, Torino

11000

University Clinical Center of Serbia, Belgrade

12120

Thammasat Hospital, Pathum Thani

12713

King Faisal Specialist Hospital & Research Center, Riyadh

13210

Syracuse VA Medical Center, Syracuse

14080

Instituto Nacional de Cardiologia Dr. Ignacio Chavez, Mexico City

15213

University of Pittsburgh Medical Center, Pittsburgh

18009

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

20070

Pamukkale University Medical Faculty, Denizli

20246

Universitaetsklinikum Hamburg Eppendorf, Hamburg

21118

Tufts Medical Center, Boston

21201

University of Maryland, Baltimore

21204

Institute for Pulmonary Disease of Vojvodina, Kamenitz

26040

Eskisehir Osmangazi University Medical Faculty Hospital, Eskişehir

27100

Fondazione IRCCS Policlinico San Matteo, Pavia

28041

Hosp. Univ. 12 de Octubre, Madrid

28046

Hosp. Univ. La Paz, Madrid

29010

Hosp Virgen de La Victoria, Málaga

29200

CHU de Brest - Hopital de la Cavale Blanche, Brest

29603

Hosp. Costa Del Sol, Málaga

30309

Piedmont Healthcare, Atlanta

30625

Medizinische Hochschule Hannover Zentrum Innere Medizin Klinik für Pneumologie, Hanover

32608

University of Florida Health Jacksonville, Gainesville

33110

Mersin University Medical Faculty, Mersin

34096

Istanbul University - Cerrahpasa Cardiology Institution, Istanbul

34295

CHU de Montpellier - Arnaud de Villeneuve, Montpellier

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

35340

Dokuz Eylul University Medical Faculty, Izmir

35392

Universitaetsklinikum Giessen, Giessen

38043

CHU de Grenoble Hopital Albert Michallon, Grenoble

40002

Srinagarind Hospital, Khon Kaen University, Khon Kaen

42277

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

44195

Cleveland Clinic, Cleveland

45007

Hosp. Gral. Univ. de Toledo, Toledo

46002

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

46202

Indiana University, Indianapolis

49059

CE 'Dnipropetrovsk Regional Clinical Center of Cardiology and Cardiosurgery', Dnipro

49241

Pusan National University Hospital, Busan

50161

Lietuvos sveikatos mokslų universiteto ligoninė Kauno klinik, Kaunas

50200

Maharaj Nakorn Chiang Mai Hospital, Chiang Mai

52787

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

53127

Universitatsklinikum Bonn, Bonn

54511

CHU de Nancy - Hopital de Brabois, Vandœuvre-lès-Nancy

56124

Fondazione Toscana Gabriele Monasterio CNR, Pisa

58260

Centro de Investigacion Clinica Chapultepec, Morelia

59037

Hôpital Cardiologique - Chru Lille, Lille

59046

King Fahad Medical City, Riyadh

60611

Northwestern University Feinberg School of Medicine, Chicago

64060

CRI Centro Regiomontano de Investigacion SC, Nuevo León

64718

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

66100

Ospedale SS. Annunziata, Chieti

66160

University of Kansas Medical Center, Kansas City

66421

Universitaetsklinikum des Saarlandes, Homburg

69126

Thoraxklinik Heidelberg, Heidelberg

75093

Baylor Scott White - Plano, Plano

79010

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

80045

University of Colorado Anschutz Medical Campus, Aurora

80639

Krankenhaus Neuwittelsbach, München

84107

Intermountain Medical Center, Murray

84132

University of Utah Cardiovascular Center, Salt Lake City

85369

Fundación Abood Shaio, Bogotá

87131

University of New Mexico School of Medicine, Albuquerque

89509

VA Sierra Nevada Health Care System, Reno

90033

Keck School of Medicine of USC, Los Angeles

92037

University of California San Diego Medical Center, La Jolla

94275

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

97210

Legacy Hospital, Portland

100020

Beijing Chaoyang Hospital, Beijing

100029

Beijing Anzhen Hospital, Beijing

China Japan Friendship Hospital, Beijing

100038

Beijing Shijitan Hospital, Beijing

110000

The General Hospital of Northern Theater Command, Shenyang

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

200040

Huashan Hospital of Fudan University, Shanghai

200433

Shanghai Pulmonary Hospital, Shanghai

210009

Zhongda Hospital Southeast University, Nanjing

266003

The Affiliated Hospital of Medical College Qingdao University, Qingdao

300052

Tianjin Medical University General Hospital, Tianjin

310016

Sir Run Run Shaw Hospital Zhejiang University School of Medicine, Hangzhou

400008

Volgograd Regional Clinical Cardiology Center, Volgograd

400016

The First Affiliated Hospital of Chongqing Medical University, Chongqing

420101

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

510140

The First Affiliated Hospital of Guangzhou Medical University, Guangzhou

540136

Spitalul Clinic Judetean de Urgenta, Tg. Mures

681004

Centro Cardiovascular Colombiano Clínica Santa María, Medellín

710061

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

760042

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

1101131

Fundacion Neumologica Colombiana, Bogotá

5265601

The Chaim Sheba Medical Center, Tel Litwinsky

6423906

Tel Aviv Medical Center, Tel Aviv

95817-2201

UC Davis Medical Center, Sacramento

06519

Yale University School Of Medicine, New Haven

02114

Massachusetts General Hospital, Boston

68198-2265

University of Nebraska Medical Center, Omaha

53792-2442

University of Wisconsin Hospital and Clinics, Madison

C1006ACC

Nexo Salud Investigacion Clinica, Buenos Aires

C1039AAO

Sanatorio de la Trinidad Mitre, Buenos Aires

C1180AAX

Sanatorio Guemes, C.a.b.a.

T1Y 6J4

University Of Calgary - Peter Lougheed Centre, Calgary

T6G 2B7

University of Alberta Hospital, Edmonton

M5G 2N2

University Health Network - Toronto General Hospital, Toronto

Unknown

Zhongshan Hospital Fudan University, Shanghai

Hopital Larrey CHU de Toulouse, Toulouse

128 08

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

01307

Medizinische Fakultaet Carl Gustav Carus Technische Universitaet Dresden, Dresden

07747

Universitatsklinikum Jena, Jena

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

216 8511

St Marianna University Hospital, Kanagawa

650 0017

Kobe University Hospital, Kobe

602-8566

University Hospital Kyoto Prefectural University of Medicine, Kyoto

606 8507

Kyoto University Hospital, Kyoto

390 8621

Shinshu University Hospital, Matsumoto

153-8515

Toho University Medical Center, Ohashi Hospital, Meguro-ku

181-8611

Kyorin University Hospital, Mitaka

466 8560

Nagoya University Hospital, Nagoya

701-1192

National Hospital Organization Okayama Medical Center, Okayama

060-8648

Hokkaido University Hospital, Sapporo

564-8565

National Cerebral and Cardiovascular Center, Suita-Shi

113-8431

Juntendo University Hospital, Tokyo

305 8576

University of Tsukuba Hospital, Tsukuba

LT-08661

Vilnius University Hospital Santariskiu Klinikos, Vilnius

31 202

Krakowski Szpital Specjalistyczny im Jana Pawla II, Krakow

20 708

Wojewodzki Szpital Specjalistyczny im Stefana Kardynala Wyszynskiego PZOZ, Lublin

05 400

Europejskie Centrum Zdrowia Otwock Sp z o o, Otwock

2805 267

Uls Almada Seixal - Hosp. Garcia de Orta, Almada

022328

Institutul de urgenta pentru Boli Cardiovasculare Prof. Dr. C.C. Iliescu, Bucharest

833 48

Narodny ustav srdcovych a cievnych chorob, Bratislava

03080

Seoul National University Hospital, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

06591

The Catholic University of Korea Seoul St Marys Hospital, Seoul

08036

Hosp Clinic de Barcelona, Barcelona

01170

Adana City Hospital, Adana

01250

Cukurova University Medical Faculty, Adana

06230

Hacettepe University Medical Faculty, Ankara

06800

Ankara Bilkent Sehir Hastanesi, Ankara

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

CB2 0AY

Papworth Hospital NHS Trust, Cambridge

G81 4DY

National Waiting Times Centre Board Golden Jubilee National Hospital, Glasgow

NW3 2QG

Royal Free Hospital, London

W12 0HS

Hammersmith Hospital, London

NE7 7DN

Freeman Hospital, Newcastle upon Tyne

S10 2RX

Sheffield Teaching Hospitals NHS Foundation Trust Royal Hallamshire Hospital, Sheffield

Sponsors

Lead Sponsor

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INDUSTRY

NCT04271475 - A Study to Evaluate Efficacy and Safety of Macitentan 75 mg in Inoperable or Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension | Biotech Hunter | Biotech Hunter