Study of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension

PHASE3CompletedINTERVENTIONAL
Enrollment

742

Participants

Timeline

Start Date

May 31, 2008

Primary Completion Date

March 31, 2012

Study Completion Date

April 30, 2012

Conditions
Pulmonary Arterial Hypertension
Interventions
DRUG

macitentan (ACT-064992)

Tablet, 3 mg dosage, once daily

DRUG

macitentan (ACT-064992)

Tablet, 10 mg dosage, once daily

DRUG

placebo

Matching placebo, once daily

Trial Locations (153)

1309

Specialized Hospital for Active Treatment of Cardio-Vascular Diseases / Department of Pediatric Cardiology, Sofia

2000

Netcare Milpark Hospital,Center for Chest Disease, Johannesburg

2010

St. Vincent's Hospital, Darlinghurst, NSW

3181

The Alfred Hospital, Melbourne, VIC

4558

Royal Brisbane Hospital, Sunshine Coast

7130

Block 4, Vergelegen Medi-Clinic, Somerset West

7505

Tread Research, Parow

10400

Ramathibodi Hospital, Mahidol University, Cardiology Unit, Department of Medicine,, Bangkok

10700

Siriraj Hospital/ Department of Pediatrics, Faculty of Medicine, Siriraj Hospital, Mahidol University, Bangkok

11000

University Children's Hospital (UNIVERZITETSKA DEČJA KLINIKA), Belgrade

University Clinical Center of Serbia / Institute for Lung Diseases and Tuberculosis, Belgrade

11080

"Zemun Clinical Hospital (Kliničko-bolnički centar Zemun ) / Department of Cardiology", Belgrade

14080

'Instituto Nacional de Cardiología (INC) Ignacio Chávez, Mexico City

15006

Hospital Juan Canalejo Servicio de Neumología, A Coruña

20841

Hospital 12 Octubre/ Cardiology department Planta 5a., Madrid

21201

University of Maryland School of Medicine, Baltimore

23507

Sentara Hospital T/A Sentara Cardiovascular Research Institute, Norfolk

29010

Hospital Clínico Virgen de la Victoria / Pneumology Unit,, Málaga

30322

Emory University Hospital - McKelvey Center for Lung Transplantation & Pulmonary Vascular Disease, Atlanta

30342

Pulmonary & Critical Care of Atlanta, Atlanta

33604

Hopital Haut-Leveque - Maison du Haut-Leveque, Pessac

34295

Hôpital Arnaud de Villeneuve Service des Maladies Respiratoires, Montpellier

34362

Lady Davis Carmel Medical Center / Department of Cardiovascular Medicine, Pulmonary Division, Haifa

36771

Hospital Montecelo, Servicio de Neumología, Pontevedra

40002

Srinagarind Hospital/Division of Rheumatology, Department of Medicine, Faculty of Medicine, Khon Kaen University, Khon Kaen

40705

Taichung Veterans General Hospital / Division of Allergy, Immunology and Rheumatology, Taichung

43210

Ohio State University, Columbus

49060

Dnipropetrovsk State Medical Academy / Regional Diagnostic Center, Department of electrophysiologic researches and anaesthesiologic aid, Dnipro

49100

Rabin Medical Center - Belinson campus - Pulmonary Institute, Petach - Tikvah

50159

"Institutul de Pneumologie Marius Nasta / I. Clinica de Pneumoftiziologie", Bucharest

50400

Institut Jantung Negara (National Heart Institute), Kuala Lumpur

52621

The pulmonary institute Sheba Medical centre, Tel Litwinsky

63110

Washington University School of Medicine, St Louis

64020

Unidad de Investigación Clinica en Medicina, SC, Monterrey Nuevo León

64239

Sourasky Medical Center - Division of Pulmonary Medicine and Allergy, Tel Aviv

66160

University of Kansas Medical Center, Kansas City

75235

University of Texas Medical Center - St. Paul University, Dallas

76100

Pulmonary Institute, Kaplan Medical Center, Rehovot

77030

Baylor College of Medicine and the Methodist Hospital, Houston

79010

Danylo Halytskyi Lviv State Medical University, Lviv

85013

Arizona Pulmonary Specialists, Pheonix

92140

Hôpital Antoine Béclère / Service de Pneumologie, Clamart

93053

Universitätsklinikum Regensburg / Innere Medizin II, Regensburg

100029

Beijing Anzhen Hospital of the Capital University of Medical Sciences, Cardiology Department, Beijing

100032

Peking Union Medcical College Hospital, Rheumatology Department, Beijing

100853

Chinese PLA General Hospital (301 Hospital), Cardiology Department, Beijing

105077

"Federal State Institution Scientific Research Institute of Pulmonology of Roszdrav", Moscow

110049

G B Pant Hospital & Maulana Azad Medical College, Delhi

117049

"State Health Care Institution of Moscow City Clinical Hospital #1 named after N. I. Pirogov", Moscow

121552

"Federal State Institution Russian Cardiology Scientific and Production Complex of Rosmedtechnology", Moscow

168752

National University Hospital/ The Heart Institute, Singapore

Singapore General Hospital, Singapore

194156

"Federal State Institution Federal Center of Heart, Blood and Endocrinology named after V.A. Almazov of Rosmedtechnology", Saint Petersburg

200001

Renji Hospital, Rheumatology Dept, Shanghai

200032

Zhongshan Hospital Fudan University, Cardiology Dept, Shanghai

200127

Renji Hospital, Cardiology Dept, Shanghai

200433

Shanghai Pulmonary Hospital, Dept of Pulmonary Circulation, Shanghai

210029

Jiangsu Province Hospital - Pneumology Department, Nanjing

210037

Vitebsk Regional Clinical Hospital, Vitebsk

220036

Republican reserach - Pratical Centre of Cardilogy, Minsk

223040

Minsk Regional Clinical Hospital, Minsk

382428

Life Care Institute of Medical Science & Research, Ahmedabad, Ahmedabad

400016

P D Hinduja National Hospital and Medical Research Centre/ Pulmunory Medicine, Mumbai

500001

Care Hospital, Hyderabad

510080

Guangdong General Hospital, Cardiology Department, Guangzhou

620102

Sverdlovsk Regional Clinical Hospital # 1/ Cardiology Department (2nd Therapy Department), Yekaterinburg

634063

"State Institution Scientific Research Institute of Cardiology of Tomsk Scientific Center of RAMS, Siberian branch", Tomsk

Tomsk Regional Clinical Hospital / Pulmonology Unit, Tomsk

650002

"Municipal Health Care Institution Kemerovo Cardiology Dispensary", Kemerovo

35249-0001

University of Alabama at Birmingham, Birmingham

Unknown

GLVA Healthcare Center, Los Angeles

University of California, San Diego, San Diego

Santa Barbara Cottage Hospital, Santa Barbara

Liu Center for Pulmonary Hypertension, Torrance

University of Colorado Health Sciences Center, Denver

Mayo Clinic, Jacksonville, Jacksonville

Southeastern Lung Care, Decatur

University of Chicago Hospitals, Chicago

University of Iowa, Iowa City

Kentuckiana Pulmonary Associate, PLLC, Louisville

Medical Center of Louisiana at New Orleans, New Orleans

Boston University School of Medicine, Boston

Pulmonary/Critical Care Division/Tufts New England Medical Center, Boston

University of Michigan, Ann Arbor

University of NJ - Robert Wood Johnson Medical School, New Brunswick

Columbia University Medical Center - Pediatric Cardiology, New York

Duke University Medical Center, Durham

University of Cincinnati Ohio Heart Health Center, Cincinnati

Vanderbilt University Medical Center, Nashville

Dept. of Pulmonary Medicine - Latter Day Saints Hospital, Salt Lake City

Comprehensive Cardiovascular Care Group, Milwaukee

Hospital Britanico, Buenos Aires

Sanatorio MITRE, Buenos Aires

SANATORIO OTAMENDI y MIROLI, Buenos Aires

Instituto Cardiologia Corrientes, Corrientes

Htal Italiano Cordoba, Córdoba

Htla privado de Cordoba, Córdoba

'Hospital Italiano - Garibaldi de Rosario, Santa Fe

Medical University of Vienna/ Department of Internal Medicine II, Division of Cardiology, Vienna

University Hospital Gasthuisberg / Kliniekhoofd, Interne Geneeskunde - I.G. Pneumologie, Leuven

London Health Sciences Centre / Victoria Hospital, London

L'Hopital Laval, Saint-Foy

Peter Lougheed Centre, Calgary

Toronto General Hospital, Toronto

'Pontificia Universidad Catolica de Chile, Santiago

Hospital del Torax, Santiago

Hospital San Juan de Dios, Santiago

Fundación Clínica Shaio, Bogotá

'Fundacion Cardiovascular de Colombia, Floridablanca, Santander

Unfallkrankenhaus Berlin, Klinik für Innere Medizin, Berlin

Prince of Wales Hospital/ Division of Rheumatology, Department of Medicine & Therapeutics, Hong Kong

Queen Mary Hospital / Division of Cardiology, Department of Medicine, Hong Kong

University of Szeged Albert Szent-Györgyi Medical and Pharmaceutical Center, Faculty of General Medicine, II. Internal Medicine Clinic, Cardiology Center, Szeged

Hospital Alberto Sabogal Sologuren - EsSALUD, Lima

IInstituto de Enfermedades Respiratorias, Clinica San Gabriel, Lima

National Taiwan University Hospital/ Thoracic Surgical Division, Surgical Department, Taipei

Chiang Mai Hospital / Division of Rheumatology, Department of Medicine, Faculty of Medicine, Chiang Mai University, Chiang Mai

Istanbul University Cardiology Institure, Istanbul

04102

Maine Medical Center, Portland

C1093AAS

Fundacion Favaloro, Buenos Aires

V6Z 1Y6

Vancouver General Hospital, Vancouver

51 000

Clinical Hospital Center, Rijeka

D-50924

Universität zu Köln, Medizinische Klinik III, Abteilung Kardiologie, Cologne

D-01307

Medizinische Klinik und Poliklinik I Universitätsklinikum Carl Gustav Carus, Dresden

D-35392

Universitätsklinikums Gießen und Marburg GmbH / Medizinische Klinik und Poliklinik II, Innere Med., Giessen

D-17487

Universität Greifswald / Klinik für Innere Medizin B,, Greifswald

D-20246

Universitätsklinikum Hamburg-Eppendorf / Onkologie, Hämatologie und Knochenmarktransplantation mit Sektion Pneumologie, Hamburg

D-69126

Thoraxklinik am Universitätsklinikum Heidelberg, Heidelberg

D-66421

Universitätskliniken des Saarlandes / Medizinische Klinik und Poliklinik, Innere Medizin V, Homburg/Saar

04103

Universtätsklinik Leipzig, Leipzig

D-55131

Klinikum der Johannes Gutenberg-Universität / II. Medizinische Klinik und Poliklinik, Mainz

D-81377

Medizinische Klinik und Poliklinik I der Ludwig-Maximilians-Universität München / Klinikum Großhadern, Schwerpunkt Pneumologie, Munich

H-1096

Gottsegen György Országos Kardiológiai Intézet (Hungarian Institute of Cardiology), Budapest

H-1125

Semmelweis University, Pulmonolgy Clinic, Budapest

400 012

King Edward VII Memorial Hospital (KEM) Hospital, Mumbai

411 004

Deenanath Mangeshkar Hospital and Research Centre, Pune

00161

Policlinico Umberto I, Cardiologia, Roma

3435 CM

St. Antonius ziekenhuis, Nieuwegein

N0514

Aker University Dept of Cardilogy, Oslo

31-202

Klinika Chorob Serca i Naczyn Instytut Kardiologii Collegium Medicum UJ, Krakow

01-138

Klinika Chorób Wewnętrznych Klatki Piersiowej, Warsaw

41-800

III Katedra i Oddział Kliniczny Kardiologii Slaskiego Uniwersytetu Medycznego, Zabrze

022328

Institutul de boli cardiovasculare / Clinica de Cardiologie, Bucharest

197 022

State Educational Institution of High Professional Education, Saint Petersburg

150 003

"Municipal Health Care Institution Clinical Hospital of Emergency Care named after N.V. Soloviov", Yaroslavl

833 48

National Institute of Cardiovascular Diseases (Národný ústav srdcových a cievnych chorôb, a.s. - NÚSCH) / Department of Heart Transplantation, Bratislava

Slovak Medical University (Slovenská zdravotnícka univerzita) / Faculty of Medical Speciality Studies (Fakulta zdravotníckych špecializačných štúdií), Department of Cardiology and Angiology, Bratislava

27-11-033 8197

Chris Hani Baragwanath Hospital, Department of Cardiology, Johannesburg

08035

Hospital Universitario Vall d'Hebron, Pneumology Unit, Planta Baja Hospital General, Barcelona

08036

Hospital Clínico I Provincial, Servicio de Neumología., Barcelona

SE-221 85

University Hospital in Lund, Heart and Lung Division, Lund

751 85

Servicio de Medicina Interna, Unidad de Hipertensión Pulmonar, Uppsala

NW3 2QG

Royal Free Hospital, London

Sponsors

Lead Sponsor

All Listed Sponsors
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INDUSTRY

NCT00660179 - Study of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension | Biotech Hunter | Biotech Hunter