Study of Macitentan (ACT-064992) on Morbidity and Mortality in Patients With Symptomatic Pulmonary Arterial Hypertension
NCT ID: NCT00660179
Last Updated: 2015-09-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
742 participants
INTERVENTIONAL
2008-05-31
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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1
Macitentan (ACT-064992) tablet, 3 mg, once daily
macitentan (ACT-064992)
Tablet, 3 mg dosage, once daily
2
Macitentan (ACT-064992) tablet, 10 mg, once daily
macitentan (ACT-064992)
Tablet, 10 mg dosage, once daily
3
Matching placebo, once daily
placebo
Matching placebo, once daily
Interventions
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macitentan (ACT-064992)
Tablet, 3 mg dosage, once daily
macitentan (ACT-064992)
Tablet, 10 mg dosage, once daily
placebo
Matching placebo, once daily
Eligibility Criteria
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Inclusion Criteria
2. Patients with symptomatic pulmonary arterial hypertension (PAH) in modified World Health Organization (WHO) functional class II to IV.
3. Patients with the following types of pulmonary arterial hypertension (PAH) belonging to groups 1.1 to 1.3 of the Venice classification:
* Idiopathic (IPAH);
* Familial (FPAH); or
* Related to:
* Collagen vascular disease;
* Simple, congenital systemic-to-pulmonary shunts at least 1 year post surgical repair;
* Human immunodeficiency virus (HIV) infection; or
* Drugs and toxins.
4. PAH diagnosis confirmed by hemodynamic evaluation performed prior to randomization and showing all of the following:
* Mean pulmonary artery pressure (mPAP) \> 25 mmHg at rest;
* Pulmonary capillary wedge pressure (PCWP) or left ventricular end diastolic pressure (LVEDP) \< 15 mmHg; and
* Pulmonary vascular resistance (PVR) at rest \>= 320 dyn×sec/cm\^5.
5. 6-minute walk distance (6MWD) \>= 50 m.
6. Men or women \> 12 years of age (women of childbearing potential must have a negative pre-treatment serum pregnancy test and must use a reliable method of contraception).
Exclusion Criteria
2. PAH associated with non corrected simple congenital systemic-to-pulmonary shunts, and combined and complex systemic-to-pulmonary shunts, corrected or non corrected.
3. PAH associated with significant venous or capillary involvement (PCWP \> 15 mmHg), known pulmonary veno-occlusive disease, and pulmonary capillary hemangiomatosis.
4. Persistent pulmonary hypertension of the newborn.
5. Pulmonary Hypertension belonging to groups 2 to 5 of the Venice classification.
6. Moderate to severe obstructive lung disease: forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) \< 70% and FEV1 \< 65% of predicted value after bronchodilator administration.
7. Moderate to severe restrictive lung disease: total lung capacity (TLC) \< 60% of predicted value.
8. Moderate to severe hepatic impairment, i.e., Child-Pugh Class B or C.
9. Estimated creatinine clearance \< 30 mL/min
10. Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \> 1.5 times the upper limit of normal.
11. Hemoglobin \< 75% of the lower limit of the normal range.
12. Systolic blood pressure \< 100 mmHg.
13. Acute or chronic physical impairment (other than dyspnea), limiting the ability to comply with study requirements.
14. Pregnant or breast-feeding.
15. Known concomitant life-threatening disease with a life expectancy \< 12 months.
16. Body weight \< 40 kg.
17. Any condition that prevents compliance with the protocol or adherence to therapy.
18. Recently started (\< 8 weeks prior to randomization) or planned cardio-pulmonary rehabilitation program based on exercise.
19. Treatment with endothelin receptor antagonists (ERAs) within 3 months prior to randomization.
20. Systemic treatment within 4 week prior to randomization with cyclosporine A or tacrolimus, everolimus, sirolimus (calcineurin or mammalian target of rapamycin (mTOR) inhibitors).
21. Treatment with cytochrome P3A (CYP3A) inducers within 4 weeks prior to randomization
22. Known hypersensitivity to drugs of the same class as the study drug, or any of their excipients.
23. Planned treatment, or treatment, with another investigational drug within 1 month prior to randomization.
12 Years
ALL
No
Sponsors
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Actelion
INDUSTRY
Responsible Party
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Principal Investigators
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Loic Perchenet, PhD
Role: STUDY_CHAIR
Actelion
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Arizona Pulmonary Specialists
Pheonix, Arizona, United States
GLVA Healthcare Center
Los Angeles, California, United States
University of California, San Diego
San Diego, California, United States
Santa Barbara Cottage Hospital
Santa Barbara, California, United States
Liu Center for Pulmonary Hypertension
Torrance, California, United States
University of Colorado Health Sciences Center
Denver, Colorado, United States
Mayo Clinic, Jacksonville
Jacksonville, Florida, United States
Emory University Hospital - McKelvey Center for Lung Transplantation & Pulmonary Vascular Disease
Atlanta, Georgia, United States
Pulmonary & Critical Care of Atlanta
Atlanta, Georgia, United States
Southeastern Lung Care
Decatur, Georgia, United States
University of Chicago Hospitals
Chicago, Illinois, United States
University of Iowa
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Kentuckiana Pulmonary Associate, PLLC
Louisville, Kentucky, United States
Medical Center of Louisiana at New Orleans
New Orleans, Louisiana, United States
Maine Medical Center
Portland, Maine, United States
University of Maryland School of Medicine
Baltimore, Maryland, United States
Boston University School of Medicine
Boston, Massachusetts, United States
Pulmonary/Critical Care Division/Tufts New England Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
University of NJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Columbia University Medical Center - Pediatric Cardiology
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati Ohio Heart Health Center
Cincinnati, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Medical Center - St. Paul University
Dallas, Texas, United States
Baylor College of Medicine and the Methodist Hospital
Houston, Texas, United States
Dept. of Pulmonary Medicine - Latter Day Saints Hospital
Salt Lake City, Utah, United States
Sentara Hospital T/A Sentara Cardiovascular Research Institute
Norfolk, Virginia, United States
Comprehensive Cardiovascular Care Group
Milwaukee, Wisconsin, United States
Fundacion Favaloro
Buenos Aires, , Argentina
Hospital Britanico
Buenos Aires, , Argentina
Sanatorio MITRE
Buenos Aires, , Argentina
SANATORIO OTAMENDI y MIROLI
Buenos Aires, , Argentina
Instituto Cardiologia Corrientes
Corrientes, , Argentina
Htal Italiano Cordoba
Córdoba, , Argentina
Htla privado de Cordoba
Córdoba, , Argentina
'Hospital Italiano - Garibaldi de Rosario
Santa Fe, , Argentina
St. Vincent's Hospital
Darlinghurst, NSW, , Australia
The Alfred Hospital
Melbourne, VIC, , Australia
Royal Brisbane Hospital
Sunshine Coast, , Australia
Medical University of Vienna/ Department of Internal Medicine II, Division of Cardiology
Vienna, , Austria
Republican reserach - Pratical Centre of Cardilogy
Minsk, , Belarus
Minsk Regional Clinical Hospital
Minsk, , Belarus
Vitebsk Regional Clinical Hospital
Vitebsk, , Belarus
University Hospital Gasthuisberg / Kliniekhoofd, Interne Geneeskunde - I.G. Pneumologie
Leuven, , Belgium
Specialized Hospital for Active Treatment of Cardio-Vascular Diseases / Department of Pediatric Cardiology
Sofia, , Bulgaria
London Health Sciences Centre / Victoria Hospital
London, Ontario, Canada
L'Hopital Laval
Saint-Foy, Quebec, Canada
Peter Lougheed Centre
Calgary, , Canada
Toronto General Hospital
Toronto, , Canada
Vancouver General Hospital
Vancouver, , Canada
'Pontificia Universidad Catolica de Chile
Santiago, Chile, Chile
Hospital del Torax
Santiago, Chile, Chile
Hospital San Juan de Dios
Santiago, Chile, Chile
Guangdong General Hospital, Cardiology Department
Guangzhou, Guangdong, China
Jiangsu Province Hospital - Pneumology Department
Nanjing, Jiangsu, China
Beijing Anzhen Hospital of the Capital University of Medical Sciences, Cardiology Department
Beijing, , China
Peking Union Medcical College Hospital, Rheumatology Department
Beijing, , China
Chinese PLA General Hospital (301 Hospital), Cardiology Department
Beijing, , China
Renji Hospital, Rheumatology Dept
Shanghai, , China
Zhongshan Hospital Fudan University, Cardiology Dept
Shanghai, , China
Renji Hospital, Cardiology Dept
Shanghai, , China
Shanghai Pulmonary Hospital, Dept of Pulmonary Circulation
Shanghai, , China
Fundación Clínica Shaio
Bogotá, , Colombia
'Fundacion Cardiovascular de Colombia
Floridablanca, Santander, , Colombia
Clinical Hospital Center
Rijeka, , Croatia
Hôpital Antoine Béclère / Service de Pneumologie
Clamart, , France
Hôpital Arnaud de Villeneuve Service des Maladies Respiratoires
Montpellier, , France
Hopital Haut-Leveque - Maison du Haut-Leveque
Pessac, , France
Unfallkrankenhaus Berlin, Klinik für Innere Medizin
Berlin, , Germany
Universität zu Köln, Medizinische Klinik III, Abteilung Kardiologie
Cologne, , Germany
Medizinische Klinik und Poliklinik I Universitätsklinikum Carl Gustav Carus
Dresden, , Germany
Universitätsklinikums Gießen und Marburg GmbH / Medizinische Klinik und Poliklinik II, Innere Med.
Giessen, , Germany
Universität Greifswald / Klinik für Innere Medizin B,
Greifswald, , Germany
Universitätsklinikum Hamburg-Eppendorf / Onkologie, Hämatologie und Knochenmarktransplantation mit Sektion Pneumologie
Hamburg, , Germany
Thoraxklinik am Universitätsklinikum Heidelberg
Heidelberg, , Germany
Universitätskliniken des Saarlandes / Medizinische Klinik und Poliklinik, Innere Medizin V
Homburg/Saar, , Germany
Universtätsklinik Leipzig
Leipzig, , Germany
Klinikum der Johannes Gutenberg-Universität / II. Medizinische Klinik und Poliklinik
Mainz, , Germany
Medizinische Klinik und Poliklinik I der Ludwig-Maximilians-Universität München / Klinikum Großhadern, Schwerpunkt Pneumologie
Munich, , Germany
Universitätsklinikum Regensburg / Innere Medizin II
Regensburg, , Germany
Prince of Wales Hospital/ Division of Rheumatology, Department of Medicine & Therapeutics
Hong Kong, , Hong Kong
Queen Mary Hospital / Division of Cardiology, Department of Medicine
Hong Kong, , Hong Kong
Gottsegen György Országos Kardiológiai Intézet (Hungarian Institute of Cardiology)
Budapest, , Hungary
Semmelweis University, Pulmonolgy Clinic
Budapest, , Hungary
University of Szeged Albert Szent-Györgyi Medical and Pharmaceutical Center, Faculty of General Medicine, II. Internal Medicine Clinic, Cardiology Center
Szeged, , Hungary
Life Care Institute of Medical Science & Research, Ahmedabad
Ahmedabad, , India
G B Pant Hospital & Maulana Azad Medical College
Delhi, , India
Care Hospital
Hyderabad, , India
King Edward VII Memorial Hospital (KEM) Hospital
Mumbai, , India
P D Hinduja National Hospital and Medical Research Centre/ Pulmunory Medicine
Mumbai, , India
Deenanath Mangeshkar Hospital and Research Centre
Pune, , India
Lady Davis Carmel Medical Center / Department of Cardiovascular Medicine, Pulmonary Division
Haifa, , Israel
Rabin Medical Center - Belinson campus - Pulmonary Institute
Petach - Tikvah, , Israel
Pulmonary Institute, Kaplan Medical Center
Rehovot, , Israel
Sourasky Medical Center - Division of Pulmonary Medicine and Allergy
Tel Aviv, , Israel
The pulmonary institute Sheba Medical centre
Tel Litwinsky, , Israel
Policlinico Umberto I, Cardiologia
Roma, , Italy
Institut Jantung Negara (National Heart Institute)
Kuala Lumpur, , Malaysia
'Instituto Nacional de Cardiología (INC) Ignacio Chávez
Mexico City, , Mexico
Unidad de Investigación Clinica en Medicina, SC
Monterrey Nuevo León, , Mexico
St. Antonius ziekenhuis
Nieuwegein, , Netherlands
Aker University Dept of Cardilogy
Oslo, , Norway
Hospital Alberto Sabogal Sologuren - EsSALUD
Lima, , Peru
IInstituto de Enfermedades Respiratorias, Clinica San Gabriel
Lima, , Peru
Klinika Chorob Serca i Naczyn Instytut Kardiologii Collegium Medicum UJ
Krakow, , Poland
Klinika Chorób Wewnętrznych Klatki Piersiowej
Warsaw, , Poland
III Katedra i Oddział Kliniczny Kardiologii Slaskiego Uniwersytetu Medycznego
Zabrze, , Poland
Institutul de boli cardiovasculare / Clinica de Cardiologie
Bucharest, , Romania
Institutul de Pneumologie "Marius Nasta" / I. Clinica de Pneumoftiziologie
Bucharest, , Romania
Municipal Health Care Institution "Kemerovo Cardiology Dispensary"
Kemerovo, , Russia
Federal State Institution "Scientific Research Institute of Pulmonology of Roszdrav"
Moscow, , Russia
State Health Care Institution of Moscow "City Clinical Hospital #1 named after N. I. Pirogov"
Moscow, , Russia
Federal State Institution "Russian Cardiology Scientific and Production Complex of Rosmedtechnology"
Moscow, , Russia
Federal State Institution "Federal Center of Heart, Blood and Endocrinology named after V.A. Almazov" of Rosmedtechnology
Saint Petersburg, , Russia
State Educational Institution of High Professional Education
Saint Petersburg, , Russia
State Institution "Scientific Research Institute of Cardiology" of Tomsk Scientific Center of RAMS, Siberian branch
Tomsk, , Russia
Tomsk Regional Clinical Hospital / Pulmonology Unit
Tomsk, , Russia
Municipal Health Care Institution "Clinical Hospital of Emergency Care named after N.V. Soloviov"
Yaroslavl, , Russia
Sverdlovsk Regional Clinical Hospital # 1/ Cardiology Department (2nd Therapy Department)
Yekaterinburg, , Russia
University Children's Hospital (UNIVERZITETSKA DEČJA KLINIKA)
Belgrade, , Serbia
University Clinical Center of Serbia / Institute for Lung Diseases and Tuberculosis
Belgrade, , Serbia
Zemun Clinical Hospital (Kliničko-bolnički centar "Zemun" ) / Department of Cardiology
Belgrade, , Serbia
National University Hospital/ The Heart Institute
Singapore, , Singapore
Singapore General Hospital
Singapore, , Singapore
National Institute of Cardiovascular Diseases (Národný ústav srdcových a cievnych chorôb, a.s. - NÚSCH) / Department of Heart Transplantation
Bratislava, , Slovakia
Slovak Medical University (Slovenská zdravotnícka univerzita) / Faculty of Medical Speciality Studies (Fakulta zdravotníckych špecializačných štúdií), Department of Cardiology and Angiology
Bratislava, , Slovakia
Netcare Milpark Hospital,Center for Chest Disease
Johannesburg, , South Africa
Chris Hani Baragwanath Hospital, Department of Cardiology
Johannesburg, , South Africa
Tread Research
Parow, , South Africa
Block 4, Vergelegen Medi-Clinic
Somerset West, , South Africa
Hospital Juan Canalejo Servicio de Neumología
A Coruña, , Spain
Hospital Universitario Vall d'Hebron, Pneumology Unit, Planta Baja Hospital General
Barcelona, , Spain
Hospital Clínico I Provincial, Servicio de Neumología.
Barcelona, , Spain
Hospital 12 Octubre/ Cardiology department Planta 5a.
Madrid, , Spain
Hospital Clínico Virgen de la Victoria / Pneumology Unit,
Málaga, , Spain
Hospital Montecelo, Servicio de Neumología
Pontevedra, , Spain
University Hospital in Lund, Heart and Lung Division
Lund, , Sweden
Servicio de Medicina Interna, Unidad de Hipertensión Pulmonar
Uppsala, , Sweden
Taichung Veterans General Hospital / Division of Allergy, Immunology and Rheumatology
Taichung, , Taiwan
National Taiwan University Hospital/ Thoracic Surgical Division, Surgical Department
Taipei, , Taiwan
Ramathibodi Hospital, Mahidol University, Cardiology Unit, Department of Medicine,
Bangkok, , Thailand
Siriraj Hospital/ Department of Pediatrics, Faculty of Medicine, Siriraj Hospital, Mahidol University
Bangkok, , Thailand
Chiang Mai Hospital / Division of Rheumatology, Department of Medicine, Faculty of Medicine, Chiang Mai University
Chiang Mai, , Thailand
Srinagarind Hospital/Division of Rheumatology, Department of Medicine, Faculty of Medicine, Khon Kaen University
Khon Kaen, , Thailand
Istanbul University Cardiology Institure
Istanbul, , Turkey (Türkiye)
Dnipropetrovsk State Medical Academy / Regional Diagnostic Center, Department of electrophysiologic researches and anaesthesiologic aid
Dnipro, , Ukraine
Danylo Halytskyi Lviv State Medical University
Lviv, , Ukraine
Royal Free Hospital
London, , United Kingdom
Countries
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References
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Pulido T, Adzerikho I, Channick RN, Delcroix M, Galie N, Ghofrani HA, Jansa P, Jing ZC, Le Brun FO, Mehta S, Mittelholzer CM, Perchenet L, Sastry BK, Sitbon O, Souza R, Torbicki A, Zeng X, Rubin LJ, Simonneau G; SERAPHIN Investigators. Macitentan and morbidity and mortality in pulmonary arterial hypertension. N Engl J Med. 2013 Aug 29;369(9):809-18. doi: 10.1056/NEJMoa1213917.
Di Scala L, Bacchi M, Bayer B, Turricchia S. Adjusting Overall Survival Estimates of Macitentan in Pulmonary Arterial Hypertension After Treatment Switching: Results from the SERAPHIN Study. Adv Ther. 2022 Sep;39(9):4346-4358. doi: 10.1007/s12325-022-02253-8. Epub 2022 Aug 1.
Souza R, Delcroix M, Galie N, Jansa P, Mehta S, Pulido T, Rubin L, Sastry BKS, Simonneau G, Sitbon O, Torbicki A, Boyanova N, Chamitava L, Stein C, Channick RN. Long-Term Safety, Tolerability and Survival in Patients with Pulmonary Arterial Hypertension Treated with Macitentan: Results from the SERAPHIN Open-Label Extension. Adv Ther. 2022 Sep;39(9):4374-4390. doi: 10.1007/s12325-022-02199-x. Epub 2022 Jul 12.
Torbicki A, Bacchi M, Delcroix M, Farber HW, Ghofrani HA, Hennessy B, Jansa P, Mehta S, Perchenet L, Pulido T, Rosenberg D, Rubin LJ, Sastry BKS, Simonneau G, Sitbon O, Souza R, Wei LJ, Channick R, Benza R. Integrating Data From Randomized Controlled Trials and Observational Studies to Assess Survival in Rare Diseases. Circ Cardiovasc Qual Outcomes. 2019 May;12(5):e005095. doi: 10.1161/CIRCOUTCOMES.118.005095.
Krause A, Zisowsky J, Dingemanse J. Modeling of pharmacokinetics, efficacy, and hemodynamic effects of macitentan in patients with pulmonary arterial hypertension. Pulm Pharmacol Ther. 2018 Apr;49:140-146. doi: 10.1016/j.pupt.2018.02.005. Epub 2018 Feb 28.
McLaughlin VV, Hoeper MM, Channick RN, Chin KM, Delcroix M, Gaine S, Ghofrani HA, Jansa P, Lang IM, Mehta S, Pulido T, Sastry BKS, Simonneau G, Sitbon O, Souza R, Torbicki A, Tapson VF, Perchenet L, Preiss R, Verweij P, Rubin LJ, Galie N. Pulmonary Arterial Hypertension-Related Morbidity Is Prognostic for Mortality. J Am Coll Cardiol. 2018 Feb 20;71(7):752-763. doi: 10.1016/j.jacc.2017.12.010.
Jansa P, Pulido T. Macitentan in Pulmonary Arterial Hypertension: A Focus on Combination Therapy in the SERAPHIN Trial. Am J Cardiovasc Drugs. 2018 Feb;18(1):1-11. doi: 10.1007/s40256-017-0260-1.
Mehta S, Sastry BKS, Souza R, Torbicki A, Ghofrani HA, Channick RN, Delcroix M, Pulido T, Simonneau G, Wlodarczyk J, Rubin LJ, Jansa P, Hunsche E, Galie N, Perchenet L, Sitbon O. Macitentan Improves Health-Related Quality of Life for Patients With Pulmonary Arterial Hypertension: Results From the Randomized Controlled SERAPHIN Trial. Chest. 2017 Jan;151(1):106-118. doi: 10.1016/j.chest.2016.08.1473. Epub 2016 Sep 23.
Simonneau G, Channick RN, Delcroix M, Galie N, Ghofrani HA, Jansa P, Le Brun FO, Mehta S, Perchenet L, Pulido T, Sastry BK, Sitbon O, Souza R, Torbicki A, Rubin LJ. Incident and prevalent cohorts with pulmonary arterial hypertension: insight from SERAPHIN. Eur Respir J. 2015 Dec;46(6):1711-20. doi: 10.1183/13993003.00364-2015. Epub 2015 Oct 22.
Channick RN, Delcroix M, Ghofrani HA, Hunsche E, Jansa P, Le Brun FO, Mehta S, Pulido T, Rubin LJ, Sastry BKS, Simonneau G, Sitbon O, Souza R, Torbicki A, Galie N. Effect of macitentan on hospitalizations: results from the SERAPHIN trial. JACC Heart Fail. 2015 Jan;3(1):1-8. doi: 10.1016/j.jchf.2014.07.013. Epub 2014 Nov 11.
Other Identifiers
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AC-055-302
Identifier Type: -
Identifier Source: org_study_id
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