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

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

742 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2012-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The AC-055-302/SERAPHIN study will be an event-driven Phase III study, comparing two different doses of macitentan (ACT-064992) (3 and 10 mg) vs placebo in patients with symptomatic PAH. The main study objective is to demonstrate that macitentan (ACT-064992) prolongs time to the first morbidity or mortality event, and to evaluate the benefit/risk profile of macitentan (ACT-064992) in the treatment of patients with symptomatic PAH.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pulmonary Arterial Hypertension

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Macitentan (ACT-064992) tablet, 3 mg, once daily

Group Type EXPERIMENTAL

macitentan (ACT-064992)

Intervention Type DRUG

Tablet, 3 mg dosage, once daily

2

Macitentan (ACT-064992) tablet, 10 mg, once daily

Group Type EXPERIMENTAL

macitentan (ACT-064992)

Intervention Type DRUG

Tablet, 10 mg dosage, once daily

3

Matching placebo, once daily

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

Matching placebo, once daily

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

macitentan (ACT-064992)

Tablet, 3 mg dosage, once daily

Intervention Type DRUG

macitentan (ACT-064992)

Tablet, 10 mg dosage, once daily

Intervention Type DRUG

placebo

Matching placebo, once daily

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Signed informed consent prior to initiation of any study mandated procedure.
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

1. PAH associated with portal hypertension, thyroid disorders, glycogen storage disease, Gaucher''s disease, hereditary hemorrhagic telangiectasia, hemoglobinopathies, myeloproliferative disorders or splenectomy.
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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Actelion

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Loic Perchenet, PhD

Role: STUDY_CHAIR

Actelion

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Alabama at Birmingham

Birmingham, Alabama, United States

Site Status

Arizona Pulmonary Specialists

Pheonix, Arizona, United States

Site Status

GLVA Healthcare Center

Los Angeles, California, United States

Site Status

University of California, San Diego

San Diego, California, United States

Site Status

Santa Barbara Cottage Hospital

Santa Barbara, California, United States

Site Status

Liu Center for Pulmonary Hypertension

Torrance, California, United States

Site Status

University of Colorado Health Sciences Center

Denver, Colorado, United States

Site Status

Mayo Clinic, Jacksonville

Jacksonville, Florida, United States

Site Status

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

Atlanta, Georgia, United States

Site Status

Pulmonary & Critical Care of Atlanta

Atlanta, Georgia, United States

Site Status

Southeastern Lung Care

Decatur, Georgia, United States

Site Status

University of Chicago Hospitals

Chicago, Illinois, United States

Site Status

University of Iowa

Iowa City, Iowa, United States

Site Status

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status

Kentuckiana Pulmonary Associate, PLLC

Louisville, Kentucky, United States

Site Status

Medical Center of Louisiana at New Orleans

New Orleans, Louisiana, United States

Site Status

Maine Medical Center

Portland, Maine, United States

Site Status

University of Maryland School of Medicine

Baltimore, Maryland, United States

Site Status

Boston University School of Medicine

Boston, Massachusetts, United States

Site Status

Pulmonary/Critical Care Division/Tufts New England Medical Center

Boston, Massachusetts, United States

Site Status

University of Michigan

Ann Arbor, Michigan, United States

Site Status

Washington University School of Medicine

St Louis, Missouri, United States

Site Status

University of NJ - Robert Wood Johnson Medical School

New Brunswick, New Jersey, United States

Site Status

Columbia University Medical Center - Pediatric Cardiology

New York, New York, United States

Site Status

Duke University Medical Center

Durham, North Carolina, United States

Site Status

University of Cincinnati Ohio Heart Health Center

Cincinnati, Ohio, United States

Site Status

Ohio State University

Columbus, Ohio, United States

Site Status

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Site Status

University of Texas Medical Center - St. Paul University

Dallas, Texas, United States

Site Status

Baylor College of Medicine and the Methodist Hospital

Houston, Texas, United States

Site Status

Dept. of Pulmonary Medicine - Latter Day Saints Hospital

Salt Lake City, Utah, United States

Site Status

Sentara Hospital T/A Sentara Cardiovascular Research Institute

Norfolk, Virginia, United States

Site Status

Comprehensive Cardiovascular Care Group

Milwaukee, Wisconsin, United States

Site Status

Fundacion Favaloro

Buenos Aires, , Argentina

Site Status

Hospital Britanico

Buenos Aires, , Argentina

Site Status

Sanatorio MITRE

Buenos Aires, , Argentina

Site Status

SANATORIO OTAMENDI y MIROLI

Buenos Aires, , Argentina

Site Status

Instituto Cardiologia Corrientes

Corrientes, , Argentina

Site Status

Htal Italiano Cordoba

Córdoba, , Argentina

Site Status

Htla privado de Cordoba

Córdoba, , Argentina

Site Status

'Hospital Italiano - Garibaldi de Rosario

Santa Fe, , Argentina

Site Status

St. Vincent's Hospital

Darlinghurst, NSW, , Australia

Site Status

The Alfred Hospital

Melbourne, VIC, , Australia

Site Status

Royal Brisbane Hospital

Sunshine Coast, , Australia

Site Status

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

Vienna, , Austria

Site Status

Republican reserach - Pratical Centre of Cardilogy

Minsk, , Belarus

Site Status

Minsk Regional Clinical Hospital

Minsk, , Belarus

Site Status

Vitebsk Regional Clinical Hospital

Vitebsk, , Belarus

Site Status

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

Leuven, , Belgium

Site Status

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

Sofia, , Bulgaria

Site Status

London Health Sciences Centre / Victoria Hospital

London, Ontario, Canada

Site Status

L'Hopital Laval

Saint-Foy, Quebec, Canada

Site Status

Peter Lougheed Centre

Calgary, , Canada

Site Status

Toronto General Hospital

Toronto, , Canada

Site Status

Vancouver General Hospital

Vancouver, , Canada

Site Status

'Pontificia Universidad Catolica de Chile

Santiago, Chile, Chile

Site Status

Hospital del Torax

Santiago, Chile, Chile

Site Status

Hospital San Juan de Dios

Santiago, Chile, Chile

Site Status

Guangdong General Hospital, Cardiology Department

Guangzhou, Guangdong, China

Site Status

Jiangsu Province Hospital - Pneumology Department

Nanjing, Jiangsu, China

Site Status

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

Beijing, , China

Site Status

Peking Union Medcical College Hospital, Rheumatology Department

Beijing, , China

Site Status

Chinese PLA General Hospital (301 Hospital), Cardiology Department

Beijing, , China

Site Status

Renji Hospital, Rheumatology Dept

Shanghai, , China

Site Status

Zhongshan Hospital Fudan University, Cardiology Dept

Shanghai, , China

Site Status

Renji Hospital, Cardiology Dept

Shanghai, , China

Site Status

Shanghai Pulmonary Hospital, Dept of Pulmonary Circulation

Shanghai, , China

Site Status

Fundación Clínica Shaio

Bogotá, , Colombia

Site Status

'Fundacion Cardiovascular de Colombia

Floridablanca, Santander, , Colombia

Site Status

Clinical Hospital Center

Rijeka, , Croatia

Site Status

Hôpital Antoine Béclère / Service de Pneumologie

Clamart, , France

Site Status

Hôpital Arnaud de Villeneuve Service des Maladies Respiratoires

Montpellier, , France

Site Status

Hopital Haut-Leveque - Maison du Haut-Leveque

Pessac, , France

Site Status

Unfallkrankenhaus Berlin, Klinik für Innere Medizin

Berlin, , Germany

Site Status

Universität zu Köln, Medizinische Klinik III, Abteilung Kardiologie

Cologne, , Germany

Site Status

Medizinische Klinik und Poliklinik I Universitätsklinikum Carl Gustav Carus

Dresden, , Germany

Site Status

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

Giessen, , Germany

Site Status

Universität Greifswald / Klinik für Innere Medizin B,

Greifswald, , Germany

Site Status

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

Hamburg, , Germany

Site Status

Thoraxklinik am Universitätsklinikum Heidelberg

Heidelberg, , Germany

Site Status

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

Homburg/Saar, , Germany

Site Status

Universtätsklinik Leipzig

Leipzig, , Germany

Site Status

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

Mainz, , Germany

Site Status

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

Munich, , Germany

Site Status

Universitätsklinikum Regensburg / Innere Medizin II

Regensburg, , Germany

Site Status

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

Hong Kong, , Hong Kong

Site Status

Queen Mary Hospital / Division of Cardiology, Department of Medicine

Hong Kong, , Hong Kong

Site Status

Gottsegen György Országos Kardiológiai Intézet (Hungarian Institute of Cardiology)

Budapest, , Hungary

Site Status

Semmelweis University, Pulmonolgy Clinic

Budapest, , Hungary

Site Status

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

Szeged, , Hungary

Site Status

Life Care Institute of Medical Science & Research, Ahmedabad

Ahmedabad, , India

Site Status

G B Pant Hospital & Maulana Azad Medical College

Delhi, , India

Site Status

Care Hospital

Hyderabad, , India

Site Status

King Edward VII Memorial Hospital (KEM) Hospital

Mumbai, , India

Site Status

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

Mumbai, , India

Site Status

Deenanath Mangeshkar Hospital and Research Centre

Pune, , India

Site Status

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

Haifa, , Israel

Site Status

Rabin Medical Center - Belinson campus - Pulmonary Institute

Petach - Tikvah, , Israel

Site Status

Pulmonary Institute, Kaplan Medical Center

Rehovot, , Israel

Site Status

Sourasky Medical Center - Division of Pulmonary Medicine and Allergy

Tel Aviv, , Israel

Site Status

The pulmonary institute Sheba Medical centre

Tel Litwinsky, , Israel

Site Status

Policlinico Umberto I, Cardiologia

Roma, , Italy

Site Status

Institut Jantung Negara (National Heart Institute)

Kuala Lumpur, , Malaysia

Site Status

'Instituto Nacional de Cardiología (INC) Ignacio Chávez

Mexico City, , Mexico

Site Status

Unidad de Investigación Clinica en Medicina, SC

Monterrey Nuevo León, , Mexico

Site Status

St. Antonius ziekenhuis

Nieuwegein, , Netherlands

Site Status

Aker University Dept of Cardilogy

Oslo, , Norway

Site Status

Hospital Alberto Sabogal Sologuren - EsSALUD

Lima, , Peru

Site Status

IInstituto de Enfermedades Respiratorias, Clinica San Gabriel

Lima, , Peru

Site Status

Klinika Chorob Serca i Naczyn Instytut Kardiologii Collegium Medicum UJ

Krakow, , Poland

Site Status

Klinika Chorób Wewnętrznych Klatki Piersiowej

Warsaw, , Poland

Site Status

III Katedra i Oddział Kliniczny Kardiologii Slaskiego Uniwersytetu Medycznego

Zabrze, , Poland

Site Status

Institutul de boli cardiovasculare / Clinica de Cardiologie

Bucharest, , Romania

Site Status

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

Bucharest, , Romania

Site Status

Municipal Health Care Institution "Kemerovo Cardiology Dispensary"

Kemerovo, , Russia

Site Status

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

Moscow, , Russia

Site Status

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

Moscow, , Russia

Site Status

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

Moscow, , Russia

Site Status

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

Saint Petersburg, , Russia

Site Status

State Educational Institution of High Professional Education

Saint Petersburg, , Russia

Site Status

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

Tomsk, , Russia

Site Status

Tomsk Regional Clinical Hospital / Pulmonology Unit

Tomsk, , Russia

Site Status

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

Yaroslavl, , Russia

Site Status

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

Yekaterinburg, , Russia

Site Status

University Children's Hospital (UNIVERZITETSKA DEČJA KLINIKA)

Belgrade, , Serbia

Site Status

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

Belgrade, , Serbia

Site Status

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

Belgrade, , Serbia

Site Status

National University Hospital/ The Heart Institute

Singapore, , Singapore

Site Status

Singapore General Hospital

Singapore, , Singapore

Site Status

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

Bratislava, , Slovakia

Site Status

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

Bratislava, , Slovakia

Site Status

Netcare Milpark Hospital,Center for Chest Disease

Johannesburg, , South Africa

Site Status

Chris Hani Baragwanath Hospital, Department of Cardiology

Johannesburg, , South Africa

Site Status

Tread Research

Parow, , South Africa

Site Status

Block 4, Vergelegen Medi-Clinic

Somerset West, , South Africa

Site Status

Hospital Juan Canalejo Servicio de Neumología

A Coruña, , Spain

Site Status

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

Barcelona, , Spain

Site Status

Hospital Clínico I Provincial, Servicio de Neumología.

Barcelona, , Spain

Site Status

Hospital 12 Octubre/ Cardiology department Planta 5a.

Madrid, , Spain

Site Status

Hospital Clínico Virgen de la Victoria / Pneumology Unit,

Málaga, , Spain

Site Status

Hospital Montecelo, Servicio de Neumología

Pontevedra, , Spain

Site Status

University Hospital in Lund, Heart and Lung Division

Lund, , Sweden

Site Status

Servicio de Medicina Interna, Unidad de Hipertensión Pulmonar

Uppsala, , Sweden

Site Status

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

Taichung, , Taiwan

Site Status

National Taiwan University Hospital/ Thoracic Surgical Division, Surgical Department

Taipei, , Taiwan

Site Status

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

Bangkok, , Thailand

Site Status

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

Bangkok, , Thailand

Site Status

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

Chiang Mai, , Thailand

Site Status

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

Khon Kaen, , Thailand

Site Status

Istanbul University Cardiology Institure

Istanbul, , Turkey (Türkiye)

Site Status

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

Dnipro, , Ukraine

Site Status

Danylo Halytskyi Lviv State Medical University

Lviv, , Ukraine

Site Status

Royal Free Hospital

London, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Australia Austria Belarus Belgium Bulgaria Canada Chile China Colombia Croatia France Germany Hong Kong Hungary India Israel Italy Malaysia Mexico Netherlands Norway Peru Poland Romania Russia Serbia Singapore Slovakia South Africa Spain Sweden Taiwan Thailand Turkey (Türkiye) Ukraine United Kingdom

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type RESULT
PMID: 23984728 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35917059 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35819570 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31109190 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29501590 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29447737 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29280064 (View on PubMed)

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.

Reference Type DERIVED
PMID: 27671974 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26493786 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25457902 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

AC-055-302

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.