Selexipag (ACT-293987) in Pulmonary Arterial Hypertension
NCT ID: NCT01106014
Last Updated: 2025-10-27
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1156 participants
INTERVENTIONAL
2009-12-01
2014-10-01
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
Selexipag is up-titrated from Day 1 to Week 12 to each patient's maximum tolerated dose in the range of 200-1600 µg twice a day (b.i.d.) in 200 µg steps starting with one 200 µg oral tablet on Day 1. From Day 2 onwards, a b.i.d. dose regimen with an interval of approximately 12 hours is followed. If this dose (selexipag 200 μg b.i.d.) is well-tolerated, selexipag is up-titrated with weekly increments of 200 µg. Up-titration is followed by a stable maintenance treatment period from Week 12 onwards, up to Week 26, at the maximum tolerated dose
Selexipag
Selexipag 200 µg tablets
2
Matching placebo is administered orally with a dosing interval of approximately12 h. A (mock) up-titration scheme is followed
Placebo
Placebo tablets matching selexipag
Interventions
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Selexipag
Selexipag 200 µg tablets
Placebo
Placebo tablets matching selexipag
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* PAH belonging to the following subgroups of the updated Dana Point Clinical Classification Group 1 (Idiopathic, or Heritable, or Drug or toxin induced, or Associated (APAH) with Connective tissue disease, Congenital heart disease with simple systemic-to-pulmonary shunt at least 1 year after surgical repair, or HIV infection)
* Documented hemodynamic diagnosis of PAH by right heart catheterization, performed at any time prior to Screening
* Six minute walk distance (6MWD) between 50 and 450 m at Screening within 2 weeks prior to the Baseline Visit
* Signed informed consent
* Patients who have received prostacyclin or its analogs within 1 month before Baseline Visit, or are scheduled to receive any of these compounds during the trial
* Patients with moderate or severe obstructive lung disease
* Patients with moderate or severe restrictive lung disease
* Patients with moderate or severe hepatic impairment (Child-Pugh B and C)
* Patients with documented left ventricular dysfunction
* Patients with severe renal insufficiency
* Patients with BMI \<18.5 Kg/m2
* Patients who are receiving or have been receiving any investigational drugs within 1 month before the Baseline Visit
* Acute or chronic impairment (other than dyspnea), limiting the ability to comply with study requirements, in particular with 6MWT
* Recently conducted or planned cardio-pulmonary rehabilitation program based on exercise training
* Psychotic, addictive or other disorder limiting the ability to provide informed consent or to comply with study requirements
* Life expectancy less than 12 months
* Females who are lactating or pregnant or plan to become pregnant during the study
* Known hypersensitivity to any of the excipients of the drug formulations
18 Years
75 Years
ALL
No
Sponsors
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Actelion
INDUSTRY
Responsible Party
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Principal Investigators
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Aline Frey
Role: STUDY_DIRECTOR
Actelion
Locations
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University of South Alabama
Mobile, Alabama, United States
The University of Arizona, Clinical and Translational Science (CATS) Research Center
Tucson, Arizona, United States
University of California San Diego Medical Center (La Jolla)
La Jolla, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
GLVA Healthcare Center
Los Angeles, California, United States
University of California, Davis, UC Davis Medical Center
Sacramento, California, United States
LIU Center for Pulmonary Hypertension
Torrance, California, United States
Lung Health & Sleep Emhancement Center, LLC
Newark, Delaware, United States
Emory University School of Medicine, Division of Pulmonary, Allergy and Critical Care Medicine
Atlanta, Georgia, United States
Georgia Health Sciences University
Augusta, Georgia, United States
Georgia Clinical Research
Austell, Georgia, United States
Clarian North Hospital
Carmel, Indiana, United States
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
Kentuckiana Pulmonary Associates
Louisville, Kentucky, United States
LSU Health Science Center - New Orleans
New Orleans, Louisiana, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital - Pulmonary Critical Care Unit
Boston, Massachusetts, United States
Massachusetts General Hospital-Pulmonary Critical Care Unit
Boston, Massachusetts, United States
Boston University School of Medicine / Boston University Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
Beaumont Hospital
Troy, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Newark Beth Isreal Medical Center-Department of Pulmonary Medicine
Newark, New Jersey, United States
Columbia University Medical Center, Pediatric Cardiology
New York, New York, United States
Montefiore Medical Center, Weiler Division
The Bronx, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
The Lindner Clinical Trial Center
Cincinnati, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
University Hospitals Case Medical Center
Cleveland, Ohio, United States
The Ohio State University Medical Center
Columbus, Ohio, United States
Oregon Pulmonary Associates, PC
Portland, Oregon, United States
Central Bucks Specialists
Doylestown, Pennsylvania, United States
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Vanderbilt Medical Center
Nashville, Tennessee, United States
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Texas-Houston Health Center Department of Pulmonary & Critical Care
Houston, Texas, United States
University of Wisconsin Hospital-Department of Medicine
Madison, Wisconsin, United States
St. Luke's Medical Center
Milwaukee, Wisconsin, United States
Froedtert Hospital - Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Centro de Investigacion y Prevencion Cardiovascular (CIPREC)
Buenos Aires, , Argentina
Sanatorio Otamendi y Miroli S.A.
Buenos Aires, , Argentina
Hospital Britanico-Pneumology
Buenos Aires, , Argentina
Sanatorio San Jose
Buenos Aires, , Argentina
Instituto De Cardiologia de Corrientes
Corrientes, , Argentina
Hospital Privado Centro Medico de Cordoba S.A.
Córdoba, , Argentina
St. Vincent's Hospital / Heart and Lung Transplant Unit
Darlinghurst, New South Wales, Australia
Prince Charles Hospital Lung Transplant, Thoracic Department
Chermside, Queensland, Australia
Royal Adelaide Hospital, Cardiovascular Investigation Unit (CVIU)
Adelaide, South Australia, Australia
Flinders Medical Centre, Pulmonary Hypertension, c/- Cardiology
Bedford Park, South Australia, Australia
St Vincent's Hospital
Fitzroy, Victoria, Australia
Royal Hobart Hospital, Centre for Clinical Research
Hobart, , Australia
John Hunter Hospital Autoimmune Resource and Research Centre
New Lambton, , Australia
Royal Melbourne Hospital, Department of Respiratory and Sleep Medicine
Parkville, , Australia
Royal Perth Hospital
Perth, , Australia
Medizinische Universität Graz
Graz, , Austria
Medical University of Vienna and AKH Cardiology
Vienna, , Austria
The Republican Scientific-Practical Center "Cardiology"
Minsk, , Belarus
Minsk City Hospital No. 9
Minsk, , Belarus
Minsk Regional Clinical Hospital of the Red Banner of Labour
Minsk, , Belarus
Ulb Erasme, Cardiology
Brussels, , Belgium
University Hospital Gasthuisberg - Pneumologie
Leuven, , Belgium
University of Alberta Hospital - Children's Centre
Edmonton, Alberta, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
Health Sciences Centre
Winnipeg, Manitoba, Canada
University of Ottawa Heart Institute
Ottawa, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Hopital General Juif (Jewish General Hospital)
Montreal, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Quebec
Québec, Quebec, Canada
Instituto Nacional del Torax Teaching Dept
Santiago, , Chile
Clinica Tabancura- Cardiology Unit
Santiago, , Chile
Pontificia Universidad Catolica de Chile-Departmento De Enfermedades Cardiovasculares
Santiago, , Chile
Peking Union Medical College Hospital, Rheumatology Department
Beijing, , China
Cardiovascular Institute & Fuwai Hospital-Pulmonary Vascular Center
Beijing, , China
Beijing Shijitan Hospital
Beijing, , China
Guangdong General Hospital, Cardiology Department
Guangzhou, , China
Renji Hospital, Rheumatology Department
Shanghai, , China
Renji Hospital, Cardiology Department
Shanghai, , China
Shanghai Pulmonary Hospital, Department of Pulmonary Circulation
Shanghai, , China
Fundacion Cardio Infantil
Bogotá, , Colombia
Fundacion Clinica Shaio
Bogotá, , Colombia
Gen Faculty Hosp Prague Cardiology Clin
Prague, , Czechia
Aarhus University Hospital , Cardiology
Aarhus, , Denmark
Rigshospitalet, Hjertemedicinsk klinik - Cardiology
Copenhagen, , Denmark
Hosp Pradel Lyon - Dpt Pneumology
Bron, , France
Hosp Cote de Nacre - Dpt Pneumology
Caen, , France
Hosp A. Beclere - Dept Pulmo & Resp Intensive Care
Clamart, , France
Hosp Huriez - Dpt Internal Medecine
Lille, , France
Hosp Civil - Dpt Pneumology
Strasbourg, , France
Hosp Larrey - Dpt Pneumology
Toulouse, , France
DRK Kliniken Köpenick
Berlin, , Germany
"Universitätsklinikum Köln Herzzentrum / Klinik III für Innere Medizin (Kardiologie, Pneumologie, Angiologie und Intensivmedizin)"
Cologne, , Germany
Universitätsklinikum Carl Gustav Carus, Medizinische Klinik1-Pneumologie/MK1-A13
Dresden, , Germany
"Justus-Liebig-Universität Gießen Zentrum für Innere Medizin Medizinische Klinik II"
Giessen, , Germany
Universität Greifswald / Klinik für Innere Medizin B
Greifswald, , Germany
Medizinische Hochschule Hannover / Klinik für Pneumologie
Hanover, , Germany
Thoraxklinik am Universitätsklinikum Heidelberg
Heidelberg, , Germany
Praxis für Pneumologie und Allergologie
Leipzig, , Germany
Klinik Löwenstein gGmbH, Medizinische Klinik 1, Pneumologie - Kardiologie
Löwenstein, , Germany
Universitätsklinkum Regensburg / Innere Medizin II
Regensburg, , Germany
Onasseio Cardiosurgical Hospital
Athens, , Greece
"Gottsegen György Országos Kardiológiai Intézet, Felnőtt kardiológiai osztály"
Budapest, , Hungary
"Semmelweis Egyetem, Pulmonológiai Klinika"
Budapest, , Hungary
Egészségügyi Járóbeteg Központ Kardiológiai Intézete - Debrecen
Debrecen, , Hungary
"Pécsi Tudományegyetem Klinikai Központ,
Pécs, , Hungary
"Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ, II. sz. Belgyógyászati klinika és Kardiológiai központ"
Szeged, , Hungary
Sanjivani Hospitals - Department of Cardiology
Ahmedabad, , India
Apollo Hospitals, Chennai
Chennai, , India
Frontier Lifeline Hospitals, Dr KM Cherian Heart Foundation, Chennai
Chennai, , India
CARE Hospitals Nampally, Cardiology Dep. Hyderabad
Hyderabad, , India
Apollo Indraprastha Hospitals
New Delhi, , India
Mater Miscordiae University Hospital
Dublin, , Ireland
Carmel Medical Center, Pulmonary Unit
Haifa, , Israel
Pulmonology Institute, Hadassah University Hospital at Ein Karem
Jerusalem, , Israel
Rabin Medical Centre - Pulmonology
Petach Tikvah, , Israel
Kaplan Medical - Pulmonary Institute
Rehovot, , Israel
The Chaim Sheba Med Ctr -Pulmonology
Tel Litwinsky, , Israel
Policlinico S. Orsola-Malpighi - Dipartimento Cardio-Toraco-Vascolare
Bologna, , Italy
Seconda Università Degli Studi di Napoli - Azienda Universitaria Policlinico - Dipartimento Assistenziale di medicina Generale, Angiologia, Endocrinologia, Epatogastroenterologia e Reumatologia - Unità Operativa di Reumatologia
Napoli, , Italy
ISMETT - Istituto Mediterraneo Trapianti e Terapie ad Alta Specializzazione - Dipartimento di Medicina - Divisione di Pneumologia
Palermo, , Italy
Institut Jantung Negara (National Heart Institute)
Kuala Lumpur, , Malaysia
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubrian
Mexico City, , Mexico
Instituto Nacional de Cardiologia (INC) Ignacio Chavez
Mexico City, , Mexico
VU Medisch Centrum / Afdeling longziekten, secretariaat 4A 48
Amsterdam, , Netherlands
Academisch Ziekenhuis Maastricht / Department of Pulmonary Diseases
Maastricht, , Netherlands
St. Antonius Ziekenhuis afdeling Longziekten
Nieuwegein, , Netherlands
Erasmus Medisch Centrum Rotterdam afdeling longziekten
Rotterdam, , Netherlands
Hospital Nacional Edgardo Rebagliati / Unidad de Investigacion Cardiologia 2
Lima, , Peru
Instituto de Enfermedades Respiratorias Clinica San Gabriel
Lima, , Peru
"Uniwersyteckie Centrum Kliniczne II Klinika Kardiologii i Elektroterapii Serca"
Gdansk, , Poland
"Instytut Kardiologii Collegium Medium UJ Krakowski Szpital Specjalistyczny im Jana Pawła II Klinika Chorób Serca i Naczyń"
Krakow, , Poland
"Wojewódzki Specjalistyczny Szpital im. dr Władysława Biegańskiego Oddział Kardiologiczny, II Katedra i Klinika Kardiologii UM"
Lodz, , Poland
"Instytut Gruźlicy i Chorób Płuc Klinika Chorób Wewnętrznych Klatki Piersiowej"
Warsaw, , Poland
"Institutul de Pneumologie "Marius Nasta", I. Clinica de Pneumoftiziologie"
Bucharest, , Romania
"Spitalul Clinic de Pneumoftiziologie Iasi Sectia Clinica I de Pneumoftiziologie"
Iași, , Romania
Municipal Medical Institution City Hospital #5
Barnaul, , Russia
Kemerovo Cardiology Dispensary / Kemerovo Regional Hospital
Kemerovo, , Russia
Scientific Research Institute of Pulmonology of the Federal Medical and Biological Agency of Russia
Moscow, , Russia
State Institution, "Institute fo Rheumatology of RAMS"
Moscow, , Russia
The Institution of the Clinical Cardiology named after A. L. Myaskinov
Moscow, , Russia
Limited liability company, Consultative diagnostic centre Healthy Joints
Novosibirsk, , Russia
V. A. Almazov Institute of Cardiology, Russian Ministry of Healthcare and Social Development / Medical Treatment and Rehabilitation Complex
Saint Petersburg, , Russia
Cardiology Scientific Research Institute of Tomsk Scientific Center of RAMs, Siberian Branch / Cardiovascular Surgery Department
Tomsk, , Russia
Tomsk Regional Clinical Hospital/ Pulmonology Unit
Tomsk, , Russia
Regional Clinical Hospital # 1
Yekaterinburg, , Russia
"Klinički Centar Srbije, Klinika za pulmologiju"
Belgrade, , Serbia
"Kliničko-bolnički centar Zemun, Kardiološko odeljenje"
Belgrade, , Serbia
National Heart Centre (NHC) Singapore
Singapore, , Singapore
Národný ústav srdcových a cievnych chorôb, a.s. - NÚSCH a.s.
Bratislava, , Slovakia
Gil Medical Centre
Incheon, , South Korea
Seoul Nathional University Hospital
Seoul, , South Korea
Yonsei University Health System Dept of Cardiology
Seoul, , South Korea
Samsung Medical Center, Division of Cardiology
Seoul, , South Korea
"The Catholic University of Korea, Seoul St. Mary's Hospital Department of Cardiology"
Seoul, , South Korea
Hosp Vall D'Hebron - Barcelona - Pneumology
Barcelona, , Spain
Clinic-Barcelona
Barcelona, , Spain
Hospital 12 Octubre
Madrid, , Spain
Sahlgrenska Universitetssjukhuset, Kardiologi
Gothenburg, , Sweden
Linköping University Hospital, Cardiology
Linköping, , Sweden
Umeå University Hospital, Cardiology (Umeå)
Umeå, , Sweden
Uppsala Akademiska Sjukhuset, Kardiologkliniken 50F
Uppsala, , Sweden
University Hospital Basel Division of Pneumology
Basel, , Switzerland
Universitätsspital Bern, Clinic for Pneumology (Inselspital)
Bern, , Switzerland
HUG Hôpitaux Universitaires de Genève; Pneumology, PAH
Geneva, , Switzerland
Kantonsspital St. Gallen Klinik für Pneumologie
Sankt Gallen, , Switzerland
Kaohsiung Veterans General Hospital (KVGH)
Kaohsiung City, , Taiwan
National Taiwan University Hospital / Department of Surgery
Taipei, , Taiwan
Srinagarind Hospital, Khon Kaen University, Division of Allergy-Immunology and Rheumatology, Department of Medicine
Khon Kaen, , Thailand
Çukurova Üniversitesi Tıp Fakültesi Kardiyoloji Anabilim Dalı
Adana, , Turkey (Türkiye)
Istanbul Üniversitesi Kardiyoloji Enstitisü
Istanbul, , Turkey (Türkiye)
Marmara Üniversitesi Tip Fakultesi Kardiyoloji Anabilim Dali
Istanbul, , Turkey (Türkiye)
Dokuz Eylül Üniversitesi Tıp Fakültesi Kardiyoloji Anabilim Dalı
Izmir, , Turkey (Türkiye)
"Dnipropetrovsk State Medical Academy, Municipal Institution ""Dnipropetrovsk Regional Clinic Diagnostic Center""
Dnipropetrovsk, , Ukraine
Health Care Municipal Institution, City Clinical Hospital #13
Kharkiv, , Ukraine
Public Institution "F.H. Yanovski Phthisiology and Pulmonology National Institute Under Ukrainian Academy of Medical Sciences"
Kyiv, , Ukraine
Lviv Regional Clinical Hospital
Lviv, , Ukraine
Golden Jubilee - Pulm Vascular Unit
Glasgow, , United Kingdom
Royal Free & Ucms Rheumatology Unit
London, , United Kingdom
Hammersmith
London, , United Kingdom
Countries
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References
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Sitbon O, Channick R, Chin KM, Frey A, Gaine S, Galie N, Ghofrani HA, Hoeper MM, Lang IM, Preiss R, Rubin LJ, Di Scala L, Tapson V, Adzerikho I, Liu J, Moiseeva O, Zeng X, Simonneau G, McLaughlin VV; GRIPHON Investigators. Selexipag for the Treatment of Pulmonary Arterial Hypertension. N Engl J Med. 2015 Dec 24;373(26):2522-33. doi: 10.1056/NEJMoa1503184.
Benza RL, Chin KM, Gaine S, Galie N, Hoeper MM, Lang IM, McLaughlin VV, Sitbon O, Doad G, Yen J, Tang X, Tapson V. Changes in REVEAL Lite 2 risk status are associated with long-term outcomes in patients with pulmonary arterial hypertension: A post-hoc analysis of the GRIPHON study. J Heart Lung Transplant. 2024 Dec;43(12):1998-2007. doi: 10.1016/j.healun.2024.08.019. Epub 2024 Aug 31.
Galie N, Gaine S, Channick R, Coghlan JG, Hoeper MM, Lang IM, McLaughlin VV, Lassen C, Rubin LJ, Hsu Schmitz SF, Sitbon O, Tapson VF, Chin KM. Long-Term Survival, Safety and Tolerability with Selexipag in Patients with Pulmonary Arterial Hypertension: Results from GRIPHON and its Open-Label Extension. Adv Ther. 2022 Jan;39(1):796-810. doi: 10.1007/s12325-021-01898-1. Epub 2021 Oct 30.
Gaine S, Sitbon O, Channick RN, Chin KM, Sauter R, Galie N, Hoeper MM, McLaughlin VV, Preiss R, Rubin LJ, Simonneau G, Tapson V, Ghofrani HA, Lang I. Relationship Between Time From Diagnosis and Morbidity/Mortality in Pulmonary Arterial Hypertension: Results From the Phase III GRIPHON Study. Chest. 2021 Jul;160(1):277-286. doi: 10.1016/j.chest.2021.01.066. Epub 2021 Feb 3.
Chin KM, Rubin LJ, Channick R, Di Scala L, Gaine S, Galie N, Ghofrani HA, Hoeper MM, Lang IM, McLaughlin VV, Preiss R, Simonneau G, Sitbon O, Tapson VF. Association of N-Terminal Pro Brain Natriuretic Peptide and Long-Term Outcome in Patients With Pulmonary Arterial Hypertension. Circulation. 2019 May 21;139(21):2440-2450. doi: 10.1161/CIRCULATIONAHA.118.039360.
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.
Coghlan JG, Channick R, Chin K, Di Scala L, Galie N, Ghofrani HA, Hoeper MM, Lang IM, McLaughlin V, Preiss R, Rubin LJ, Simonneau G, Sitbon O, Tapson VF, Gaine S. Targeting the Prostacyclin Pathway with Selexipag in Patients with Pulmonary Arterial Hypertension Receiving Double Combination Therapy: Insights from the Randomized Controlled GRIPHON Study. Am J Cardiovasc Drugs. 2018 Feb;18(1):37-47. doi: 10.1007/s40256-017-0262-z.
Gaine S, Chin K, Coghlan G, Channick R, Di Scala L, Galie N, Ghofrani HA, Lang IM, McLaughlin V, Preiss R, Rubin LJ, Simonneau G, Sitbon O, Tapson VF, Hoeper MM. Selexipag for the treatment of connective tissue disease-associated pulmonary arterial hypertension. Eur Respir J. 2017 Aug 17;50(2):1602493. doi: 10.1183/13993003.02493-2016. Print 2017 Aug.
Krause A, Machacek M, Lott D, Hurst N, Bruderer S, Dingemanse J. Population Modeling of Selexipag Pharmacokinetics and Clinical Response Parameters in Patients With Pulmonary Arterial Hypertension. CPT Pharmacometrics Syst Pharmacol. 2017 Jul;6(7):477-485. doi: 10.1002/psp4.12202. Epub 2017 May 27.
Skoro-Sajer N, Lang IM. Selexipag for the treatment of pulmonary arterial hypertension. Expert Opin Pharmacother. 2014 Feb;15(3):429-36. doi: 10.1517/14656566.2014.876007. Epub 2014 Jan 7.
Other Identifiers
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AC-065A302
Identifier Type: -
Identifier Source: org_study_id
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