Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension (SERAPHIN OL)

Long-term Single-arm Open-label Extension Study of the SERAPHIN Study, to Assess the Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension

The main objective of the AC 055 303/SERAPHIN OL study, which will follow the AC 055 302/SERAPHIN study, will be to assess the long-term safety and tolerability of ACT 064992 in patients with symptomatic PAH.

Study Overview

• Status: Completed
• Conditions: Pulmonary Arterial Hypertension
• Intervention / Treatment: Drug: Macitentan

• Study Type: Interventional
• Enrollment (Actual): 550
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1093AAS
    • Fundacion Favaloro
  • Buenos Aires, Argentina, C1039AAO
    • Sanatorio MITRE
  • Cordoba, Argentina, X5004BAL
    • Htal Italiano Cordoba
  • Cordoba, Argentina, x5016keh
    • Htla privado de Cordoba
  • Corrientes, Argentina, W3400AMZ
    • Instituto Cardiologia Corrientes
  • Santa Fe, Argentina, S2001ODA
    • Hospital Italiano - Garibaldi de Rosario
  • Ciudad Autonoma
    • Buenos Aires, Ciudad Autonoma, Argentina, C1121ABL
      • Sanatorio Otamendi y Miroli S.A.
    • Buenos Aires, Ciudad Autonoma, Argentina, C1280AEB
      • Hospital Británico
• Australia
  • Darlinghurst, Australia, 2010
    • St. Vincent's Hospital
  • Melbourne, Australia, 3004
    • The Alfred Hospital
  • Sunshine Coast, Australia, 4558
    • Royal Brisbane Hospital
• Austria
  • Vienna, Austria, 1090
    • Medical University of Vienna/ Department of Internal Medicine II, Division of Cardiology
• Belarus
  • Minsk, Belarus, 223041
    • Minsk Regional Clinical Hospital
  • Minsk, Belarus, 220036
    • Republican reserach - Pratical Centre of Cardiology
  • Vitebsk, Belarus, 210037
    • Vitebsk Regional Clinical Hospital
• Belgium
  • Leuven, Belgium, 3000
    • University Hospital Gasthuisberg
• Bulgaria
  • BG
    • Sofia, BG, Bulgaria, 1309
      • Mhat Nat Card Hosp - Pediatric Clinic
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T1Y 6J4
      • Peter Lougheed Centre
  • Ontario
    • London, Ontario, Canada, N6C 2R5
      • London Health Sciences Centre
    • Toronto, Ontario, Canada, M5G 2N2
      • Toronto General Hospital
  • Quebec
    • Sainte-Foy, Quebec, Canada, G1V 4G5
      • L'Hopital Laval
• Chile
  • Santiago, Chile, 8350488
    • Hospital San Juan de Dios
  • Santiago de Chile, Chile, 7500691
    • Hospital del Torax
  • Santiago de Chile, Chile, 833034
    • Pontificia Universidad Catolica de Chile
• China
  • Beijing, China, 100029
    • Beijing Anzhen Hospital of the Capital University of Medical Sciences, Cardiology Department
  • Beijing, China, 100032
    • Peking Union Medical College Hospital, Rheumatology Department
  • Guangzhou, China, 510080
    • Guangdong General Hospital, Cardiology Department
  • Nanjing, China, 210029
    • Jiangsu Province Hospital - Pneumology Department
  • Shanghai, China, 200001
    • Renji Hospital, Rheumatology Department
  • Shanghai, China, 200032
    • Zhongshan Hospital Fudan University, Cardiology Department
  • Shanghai, China, 200127
    • Renji Hospital, Cardiology Department
  • Shanghai, China, 200433
    • Shanghai Pulmonary Hospital Department of Pulmonary Circulation
• Colombia
  • Bogota, Colombia
    • Fundacion Clinica Shaio
  • Santander
    • Floridablanca, Santander, Colombia
      • Fundacion Cardiovascular de Colombia
• Croatia
  • Rijeka, Croatia, 51 000
    • Clinical Hospital Center
• Finland
  • Helsinki, Finland, 00290
    • Helsinki University Central Hospital
• France
  • Le Kremlin-Bicêtre cedex, France, 94275
    • Hosp Bicetre - Dept Pulmo & Resp Intensive Care
  • Montpellier, France, 34295
    • Hopital Arnaud de Villeneuve Service des Maladies Respiratoires
  • Pessac, France, 33604
    • Hopital Haut-Leveque-Maison du Haut-Leveque
• Germany
  • Berlin, Germany, 12683
    • Unfallkrankenhaus Berlin, Klinik für Innere Medizin
  • Dresden, Germany, 01307
    • Medizinische Klinik und Poliklinik I Universitätsklinikum Carl Gustav Carus
  • Essen, Germany, 45122
    • Universitätsklinikum Essen, Klinik für Kardiologie , Zentrum für Innere Medizin
  • Giessen, Germany, 35392
    • Universitätsklinikums Gießen und Marburg GmbH / Medizinische Klinik und Poliklinik II, Innere Med. / Pneumologie
  • Greifswald, Germany, 17475
    • Universität Greifswald / Klinik für Innere Medizin B,
  • Hamburg, Germany, 20246
    • Universitätsklinikum Hamburg-Eppendorf / Onkologie, Hämatologie und Knochenmarktransplantation mit Sektion Pneumologie
  • Hannover, Germany, 30625
    • Medizinische Hochschule Hannover / Klinik für Pneumologie
  • Heidelberg, Germany, 69126
    • Thoraxklinik am Universitätsklinikum Heidelberg
  • Homburg/Saar, Germany, 66421
    • Universitätskliniken des Saarlandes / Medizinische Klinik und Poliklinik, Innere Medizin V
  • Koln, Germany, 50924
    • Universität zu Köln, Medizinische Klinik III, Abteilung Kardiologie
  • Leipzig, Germany, 04103
    • Universtätsklinik Leipzig
  • Munich, Germany, 81377
    • Medizinische Klinik und Poliklinik I der Ludwig-Maximilians-Universität München / Klinikum Großhadern, Schwerpunkt Pneumologie
  • Regensburg, Germany, 93053
    • Universitatsklinikum Regensburg/Innere Medizin II
• Hong Kong
  • Hong Kong, Hong Kong
    • Prince of Wales Hospital/ Division of Rheumatology, Department of Medicine & Therapeutics
• Hungary
  • Budapest, Hungary, 1096
    • Gottsegen György Országos Kardiológiai Intézet (Hungarian Institute of Cardiology)
  • Budapest, Hungary, 1125
    • "Semmelweis Egyetem, Pulmonológiai Klinika"
  • Pecs, Hungary, 7624
    • University of Pecs, Medical School/Heart Institute and 1st Department of Internal Medicine
  • Szeged, Hungary, 6720
    • University of Szeged Albert Szent-Gyorgyi Medical & Pharmaceutical Center
• India
  • Ahmedabad, India, 382428
    • Life Care Institute of Medical Science & Research, Ahmedabad
  • Hyderabad, India, 500001
    • Care Hospital
  • Mumbai, India, 400016
    • P D Hinduja National Hospital and Medical Research Centre/ Pulmunory Medicine
  • Mumbai, India, 400012
    • Seth GS Medical College & King Edward VII Memorial (KEM) Hospital / Department Of Cardiology
  • New Delhi, India, 110 002
    • G B Pant Hospital & Maulana Azad Medical College
  • Pune, India, 411 004
    • Deenanath Mangeshkar Hospital and Research Centre
• Israel
  • Haifa, Israel, 34362
    • Lady Davis Carmel Medical Center / Department of Cardiovascular Medicine, Pulmonary Division
  • Haifa, Israel, 31096
    • Rambam Health Care Campus / Division of Medicine, Institute of Pulmonology
  • Petach - Tikvah, Israel, 49100
    • Rabin Medical Center - Belinson campus - Pulmonary Institute
  • Rehovot, Israel, 76100
    • Pulmonary Institute, Kaplan Medical Center
  • Tel Hashomer, Israel, 52621
    • The pulmonary institute Sheba Medical centre
  • Tel-Aviv, Israel, 64239
    • Sourasky Medical Center - Division of Pulmonary Medicine and Allergy
• Italy
  • Pavia, Italy, 207100
    • IRCCS Policlinico San Matteo Policlinico / Dipartimento di Cardiologia
  • Roma, Italy, 00161
    • Policlinico Umberto I, Cardiologia
• Malaysia
  • Kuala Lumpur, Malaysia, 50400
    • Institut Jantung Negara (National Heart Institute)
• Mexico
  • Mexico City, Mexico, 14080
    • Instituto Nacional de Cardiologia (INC) Ignacio Chavez
  • Monterrey, Mexico, 64718
    • Unidad De Investigacion Clinica en Medicina
• Netherlands
  • Amsterdam, Netherlands, 1081 HV
    • VU Medisch Centrum, Dept. Pulmonology 4A 48
  • Nieuwegein, Netherlands, 3435 CM
    • St. Antonius Ziekenhuis
• Peru
  • Callao, Peru, Callao 02
    • Hospital Alberto Sabogal Sologuren - EsSALUD
  • Lima, Peru, 31
    • Clinica Medica Cayetano Heredia
  • Lima, Peru, 32
    • Instituto de Enfermedades Respiratorias
• Poland
  • Krakow, Poland, 31-202
    • Klinika Chorob Serca i Naczyn Instytut Kardiologii Collegium Medicum UJ
  • Otwock, Poland, 05-400
    • Cardiology Otwock Priv
  • Zabrze, Poland, 41-800
    • III Katedra i Oddział Kliniczny Kardiologii Slaskiego Uniwersytetu Medycznego
• Romania
  • Bucharest, Romania, 050159
    • Institutul de Pneumologie "Marius Nasta" / I. Clinica de Pneumoftiziologie
  • Bucuresti, Romania, 022328
    • Institutul de boli cardiovasculare / Clinica de Cardiologie
• Russian Federation
  • Ekaterinburg, Russian Federation, 620102
    • Sverdlovsk Regional Clinical Hospital # 1/ Cardiology Department (2nd Therapy Department)
  • Kemerovo, Russian Federation, 650002
    • Municipal Health Care Institution Kemerovo Cardiology Dispensary
  • Moscow, Russian Federation, 105077
    • Federal State Institution "Scientific Research Institute of Pulmonology of Roszdrav"
  • Moscow, Russian Federation, 117049
    • State Health Care Institution of Moscow "City Clinical Hospital #1 named after N. I. Pirogov"
  • Moscow, Russian Federation, 121552
    • Federal State Institution "Russian Cardiology Scientific and Production Complex of Rosmedtechnology"
  • Moscow, Russian Federation, 101990
    • Federal State Institution "State Scientific Research Centre of Preventive Medicine" of Rosmedtechnology
  • St Petersburg, Russian Federation, 193015
    • State Educational Institution "St Petersburg Medical Academy of Postgraduate Education" of Federal Agency of Public Health and Social Development
  • St Petersburg, Russian Federation, 197 022
    • State Educational Institution of High Professional Education "St Petersburg State Medical
  • St. Petersburg, Russian Federation, 197341
    • Federal State Institution "Federal Center of Heart, Blood and Endocrinology named after V.A. Almazov" of Rosmedtechnology
  • Tomsk, Russian Federation, 634063
    • Tomsk Regional Clinical Hospital / Pulmonology Unit
  • Tomsk, Russian Federation, 634012
    • State Institution "Scientific Research Institute of Cardiology" of Tomsk Scientific Center of RAMS, Siberian branch
  • Yaroslavl, Russian Federation, 150 003
    • Municipal Health Care Institution "Clinical Hospital of Emergency Care named after N.V. Soloviov"
• Serbia
  • Belgrade, Serbia, 11000
    • University Children's Hospital (UNIVERZITETSKA DECJA KLINKIKA)
  • Belgrade, Serbia, 11000
    • University Clinical Center of Serbia/ Institute for Lung Diseases and Tuberculosis
  • Belgrade, Serbia, 11080
    • Zemun Clinical Hospital (Klinicko-bolnicki centar Zemun) / Department of Cardiology
• Singapore
  • Singapore, Singapore, 119228
    • National University Hospital/ The Heart Institute
  • Singapore, Singapore, 169609
    • National Heart Centre (NHC) Singapore
• Slovakia
  • Bratislava, Slovakia, 833 48
    • National Institute of Cardiovascular Diseases (Slovenska zdravotnicka univerzita) / Faculty of Medical Specialty Studies (Fakulta zdravotnickych speci
  • Bratislava, Slovakia, 833 48
    • Slovak Medical University (Slovenská zdravotnícka univerzita) / Faculty of Medical Speciality Studies (Fakulta zdravotníckych špecializačných štúdií)
• South Africa
  • Cape Town, South Africa, 7505
    • TREAD Research
  • Johannesburg, South Africa, 2013
    • Chris Hani Baragwanath Hospital, Department of Cardiology
  • Johannesburg, South Africa, 2193
    • Netcare Milpark Hospital,Center for Chest Disease
  • Somerset West, South Africa, 7130
    • Block 4, Vergelegen Medi-Clinic
• Sweden
  • Lund, Sweden, 221 85
    • University Hospital of Lund, Dept. of Cardiology
  • Uppsala, Sweden, 751 85
    • Uppsala University Hospital, Cardiology
• Taiwan
  • Taichung, Taiwan, 40705
    • Taichung Veterans General Hospital
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital/ Thoracic Surgical Division, Surgical Department
• Thailand
  • Bangkok, Thailand, 10400
    • Ramathibodi Hospital, Mahidol University, Cardiology Unit, Department of Medicine,
  • Bangkok, Thailand, 10700
    • Siriraj Hospital, Mahidol University
  • Chiang Mai, Thailand, 50200
    • Maharaj Nakorn Chiang Mai Hospital, Division of Rheumatology
  • Khon Kaen, Thailand, 40002
    • Srinagarind Hospital/Division of Rheumatology, Department of Medicine, Faculty of Medicine, Khon Kaen University
• Ukraine
  • Dnepropetrovsk, Ukraine, 49060
    • Dnipropetrovsk State Medical Academy / Regional Diagnostic Center, Department of electrophysiologic researches and anaesthesiologic aid
  • Lviv, Ukraine, 79010
    • Danylo Galytskyi Lviv State Medical University
  • Odessa, Ukraine, 65044
    • Odessa State Medical University, Military-medical Clinical Center of the South region
• United Kingdom
  • London, United Kingdom, NW3 2QG
    • Royal Free Hospital
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35249-0001
      • University of Alabama at Birmingham
  • Arizona
    • Phoenix, Arizona, United States, 85012
      • Arizona Pulmonary Specialists
  • California
    • La Jolla, California, United States, 92037
      • University of California, San Diego
    • Los Angeles, California, United States, 90073
      • GLVA Healthcare Center
    • Santa Barbara, California, United States, 93105
      • Santa Barbara Cottage Hospital
    • Torrance, California, United States, 90502-2006
      • LIU Center for Pulmonary Hypertension
  • Colorado
    • Aurora, Colorado, United States, 80045-2548
      • University Of Colorado Cardiac And Vascular Center
  • Florida
    • Gainesville, Florida, United States, 32610
      • University of Florida - Division of Pulmonology
    • Jacksonville, Florida, United States, 32259
      • Mayo Clinic, Jacksonville
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory University Hospital - McKelvey Center for Lung Transplantation & Pulmonary Vascular Disease
    • Atlanta, Georgia, United States, 30342-1713
      • Pulmonary & Critical Care of Atlanta
    • Decatur, Georgia, United States, 30030
      • Atlanta Institute for Medical Research
  • Illinois
    • Chicago, Illinois, United States, 60637-1432
      • University of Chicago
  • Iowa
    • Iowa City, Iowa, United States, 52242-1081
      • University of Iowa, Pulmonary Hypertension Program
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • University of Kansas Medical Center
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • Kentuckiana Pulmonary Associate, PLLC
  • Louisiana
    • New Orleans, Louisiana, United States, 70112-1393
      • Louisiana State University Health Sciences Center
  • Maine
    • Portland, Maine, United States, 04102-3134
      • Maine Medical Center
  • Maryland
    • Baltimore, Maryland, United States, 21201-1544
      • University of Maryland School of Medicine; Division of Cardiology
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
    • Boston, Massachusetts, United States, 02118
      • Boston University School of Medicine
    • Boston, Massachusetts, United States, 02111-1552
      • Pulmonary/Critical Care Division/Tufts New England Medical Center
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Detroit, Michigan, United States, 48201
      • Harper Univ. Hospital/ Wayne State University
  • Missouri
    • Saint Louis, Missouri, United States, 63110-1010
      • Washington University School of Medicine
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
  • New Jersey
    • New Brunswick, New Jersey, United States, 08903-0010
      • University of NJ - Robert Wood Johnson Medical School
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center - Pediatric Cardiology
  • North Carolina
    • Durham, North Carolina, United States, 27710-0001
      • Duke University Medical Center
  • Ohio
    • Cincinnati, Ohio, United States, 45219-2906
      • University of Cincinnati Ohio Heart Health Center
    • Columbus, Ohio, United States, 43210
      • Ohio State University, Div. of Pul. & Critical Care
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15212
      • Allegheny General Hospital
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center
  • Texas
    • Dallas, Texas, United States, 75390-8550
      • University of Texas Medical Center - St. Paul University
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine and the Methodist Hospital,
    • Houston, Texas, United States, 77030
      • University of Texas Houston Health Center
  • Utah
    • Murray, Utah, United States, 84157-5701
      • Intermountain Med Ctr- Pulm Dept Heart and Lung Ctr
  • Virginia
    • Norfolk, Virginia, United States, 23507-1904
      • Sentara Hospitals T/A Sentara Cardiovascular Research Intitute
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53125
      • Aurora St. Luke's Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Signed informed consent prior to initiation of any study-mandated procedure.
• Patients with pulmonary arterial hypertension and having completed the event-driven study, AC 055 302/SERAPHIN, or Patients who have experienced a clinical worsening of PAH in AC 055 302/SERAPHIN and for whom a written approval to roll over into this study has been obtained from the Sponsor.
• Women of childbearing potential must have a negative pre-treatment serum pregnancy test and must use a reliable method of contraception during study treatment and for at least 28 days after study treatment termination.

Exclusion Criteria:

• Any major violation of protocol AC 055 302/SERAPHIN.
• Pregnancy or breast-feeding.
• AST and/or ALT > 3 times the upper limit of the normal range.
• Any known factor or disease that might interfere with treatment compliance, study conduct or interpretation of the results, such as drug or alcohol dependence or psychiatric disease.
• Known hypersensitivity to ACT 064992 or any of the excipients.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: ACT-064992	Drug: Macitentan; Tablet, oral administration, 10 mg dose once daily; Other Names: ACT-064992

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Treatment Emergent Adverse Events (TEAEs) up to 28 Days After Study Treatment Discontinuation	An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAE are defined as AEs with onset during the treatment period or that are a consequence of a pre-existing condition that has worsened since baseline.	Up to 28 days after study treatment discontinuation (Up to 12 years)
Number of Participants With Death up to 28 Days After Study Treatment Discontinuation	Number of participants with deaths up to 28 days after study treatment discontinuation were reported.	Up to 28 days after study treatment discontinuation (Up to 12 years)
Number of Participants With Treatment Emergent Serious Adverse Events (TESAEs) up to 28 Days After Study Treatment Discontinuation	An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. TEAE are defined as AEs with onset during the treatment period or that are a consequence of a pre-existing condition that has worsened since baseline. A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly; medically significant, or requires intervention to prevent at least one of the outcomes listed above.	Up to 28 days after study treatment discontinuation (Up to 12 years)
Number of Participants With AEs Leading to Permanent Discontinuation of Study Treatment	Number of participants with AEs leading to permanent discontinuation of study treatment were reported. An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship.	Up to 28 days after study treatment discontinuation (Up to12 years)
Number of Participants With Treatment Emergent Abnormal Liver Tests up to 28 Days After Study Treatment Discontinuation	Number of participants with treatment-emergent abnormal liver tests: Alanine aminotransferase (ALT) greater than (>) 3*upper limit of normal (ULN) or aspartate aminotransferase (AST) >3* ULN, ALT >5* ULN or AST >5*ULN, ALT >8*ULN or AST >8*ULN, total bilirubin (TBIL) >2*ULN, ALT >3*ULN or AST >3*ULN and TBIL >2*ULN at any time were reported.	Up to 28 days after study treatment discontinuation (Up to12 years)
Number of Participants With Treatment Emergent Hemoglobin Abnormality up to 28 Days After Study Treatment Discontinuation	Number of participants with treatment-emergent hemoglobin (HGB) abnormality up to 28 days after study treatment discontinuation were reported. Participants assessed for different categories of HGB were <=80 grams/Liter (g/L), <=100g/L, decrease from baseline >=20 g/L, and decrease from baseline >=50 g/L.	Up to 28 days after treatment discontinuation (Up to 12 years)

Collaborators and Investigators

• Sponsor: Actelion

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 17, 2008
• Primary Completion (ACTUAL): December 7, 2020
• Study Completion (ACTUAL): December 7, 2020

Study Registration Dates

• First Submitted: April 24, 2008
• First Submitted That Met QC Criteria: April 24, 2008
• First Posted (ESTIMATE): April 28, 2008

Study Record Updates

• Last Update Posted (ACTUAL): February 10, 2022
• Last Update Submitted That Met QC Criteria: January 19, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Pulmonary Arterial Hypertension; SERAPHIN; ACT-064992
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Hypertension, Pulmonary; Hypertension; Pulmonary Arterial Hypertension; Familial Primary Pulmonary Hypertension; Molecular Mechanisms of Pharmacological Action; Endothelin Receptor Antagonists; Endothelin A Receptor Antagonists; Endothelin B Receptor Antagonists; Macitentan
• Other Study ID Numbers: AC-055-303