Clinical trial NCT01106014: Selexipag (ACT-293987) in Pulmonary Arterial Hypertension
Official title: A Multicenter, Double-blind, Placebo-controlled Phase 3 Study Assessing the Safety and Efficacy of Selexipag on Morbidity and Mortality in Patients With Pulmonary Arterial Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Arterial Hypertension
Keywords: pulmonary arterial hypertension
PAH
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2010-04-19
Enrollment: 1156
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The AC-065A302 (GRIPHON) study is an event-driven Phase 3 study to demonstrate the effect of selexipag on time to first morbidity or mortality event in patients with pulmonary arterial hypertension.


Eligibility criteria: Inclusion Criteria:

* Male and female patients 18-75 years old, with symptomatic PAH
* 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

Exclusion Criteria:

* Patients with pulmonary hypertension (PH) in the Updated Dana Point Classification Groups 2-5, and PAH Group 1 subgroups that are not covered by the inclusion criteria
* 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

Primary outcomes:
measure: Time From Randomization to the First Morbidity Event or Death (All Causes) up to 7 Days After the Last Study Drug Intake
timeFrame: Up to 7 days after end of double-blind treatment (maximum: 4.3 years)
Secondary outcomes:
measure: Change From Baseline to Week 26 in 6-minute Walk Distance (6MWD) at Trough
timeFrame: Week 26
measure: Absence of Worsening From Baseline to Week 26 in Modified NYHA/WHO Functional Class (WHO FC)
timeFrame: Week 26
Other outcomes:
Locations:
city: Mobile
country: United States
facility: University of South Alabama
state: Alabama
city: Tucson
country: United States
facility: The University of Arizona, Clinical and Translational Science (CATS) Research Center
state: Arizona
city: La Jolla
country: United States
facility: University of California San Diego Medical Center (La Jolla)
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Los Angeles
country: United States
facility: GLVA Healthcare Center
state: California
city: Sacramento
country: United States
facility: University of California, Davis, UC Davis Medical Center
state: California
city: Torrance
country: United States
facility: LIU Center for Pulmonary Hypertension
state: California
city: Newark
country: United States
facility: Lung Health & Sleep Emhancement Center, LLC
state: Delaware
city: Atlanta
country: United States
facility: Emory University School of Medicine, Division of Pulmonary, Allergy and Critical Care Medicine
state: Georgia
city: Augusta
country: United States
facility: Georgia Health Sciences University
state: Georgia
city: Austell
country: United States
facility: Georgia Clinical Research
state: Georgia
city: Carmel
country: United States
facility: Clarian North Hospital
state: Indiana
city: Iowa City
country: United States
facility: University of Iowa Hospitals & Clinics
state: Iowa
city: Louisville
country: United States
facility: Kentuckiana Pulmonary Associates
state: Kentucky
city: New Orleans
country: United States
facility: LSU Health Science Center - New Orleans
state: Louisiana
city: Baltimore
country: United States
facility: Johns Hopkins University School of Medicine
state: Maryland
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital - Pulmonary Critical Care Unit
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital-Pulmonary Critical Care Unit
state: Massachusetts
city: Boston
country: United States
facility: Boston University School of Medicine / Boston University Medical Center
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Hospital
state: Michigan
city: Troy
country: United States
facility: Beaumont Hospital
state: Michigan
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Newark
country: United States
facility: Newark Beth Isreal Medical Center-Department of Pulmonary Medicine
state: New Jersey
city: Bronx
country: United States
facility: Montefiore Medical Center, Weiler Division
state: New York
city: New York
country: United States
facility: Columbia University Medical Center, Pediatric Cardiology
state: New York
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Cincinnati
country: United States
facility: The Lindner Clinical Trial Center
state: Ohio
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Cleveland
country: United States
facility: University Hospitals Case Medical Center
state: Ohio
city: Columbus
country: United States
facility: The Ohio State University Medical Center
state: Ohio
city: Portland
country: United States
facility: Oregon Pulmonary Associates, PC
state: Oregon
city: Doylestown
country: United States
facility: Central Bucks Specialists
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt Medical Center
state: Tennessee
city: Dallas
country: United States
facility: UT Southwestern Medical Center at Dallas
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: University of Texas-Houston Health Center Department of Pulmonary & Critical Care
state: Texas
city: Madison
country: United States
facility: University of Wisconsin Hospital-Department of Medicine
state: Wisconsin
city: Milwaukee
country: United States
facility: St. Luke's Medical Center
state: Wisconsin
city: Milwaukee
country: United States
facility: Froedtert Hospital - Medical College of Wisconsin
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Centro de Investigacion y Prevencion Cardiovascular (CIPREC)
city: Buenos Aires
country: Argentina
facility: Sanatorio Otamendi y Miroli S.A.
city: Buenos Aires
country: Argentina
facility: Hospital Britanico-Pneumology
city: Buenos Aires
country: Argentina
facility: Sanatorio San Jose
city: Cordoba
country: Argentina
facility: Hospital Privado Centro Medico de Cordoba S.A.
city: Corrientes
country: Argentina
facility: Instituto De Cardiologia de Corrientes
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital / Heart and Lung Transplant Unit
state: New South Wales
city: Chermside
country: Australia
facility: Prince Charles Hospital Lung Transplant, Thoracic Department
state: Queensland
city: Adelaide
country: Australia
facility: Royal Adelaide Hospital, Cardiovascular Investigation Unit (CVIU)
state: South Australia
city: Bedford Park
country: Australia
facility: Flinders Medical Centre, Pulmonary Hypertension, c/- Cardiology
state: South Australia
city: Fitzroy
country: Australia
facility: St Vincent's Hospital
state: Victoria
city: Hobart
country: Australia
facility: Royal Hobart Hospital, Centre for Clinical Research
city: New Lambton
country: Australia
facility: John Hunter Hospital Autoimmune Resource and Research Centre
city: Parkville
country: Australia
facility: Royal Melbourne Hospital, Department of Respiratory and Sleep Medicine
city: Perth
country: Australia
facility: Royal Perth Hospital
city: Graz
country: Austria
facility: Medizinische Universität Graz
city: Vienna
country: Austria
facility: Medical University of Vienna and AKH Cardiology
city: Minsk
country: Belarus
facility: The Republican Scientific-Practical Center "Cardiology"
city: Minsk
country: Belarus
facility: Minsk City Hospital No. 9
city: Minsk
country: Belarus
facility: Minsk Regional Clinical Hospital of the Red Banner of Labour
city: Brussels
country: Belgium
facility: Ulb Erasme, Cardiology
city: Leuven
country: Belgium
facility: University Hospital Gasthuisberg - Pneumologie
city: Edmonton
country: Canada
facility: University of Alberta Hospital - Children's Centre
state: Alberta
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Winnipeg
country: Canada
facility: Health Sciences Centre
state: Manitoba
city: Ottawa
country: Canada
facility: University of Ottawa Heart Institute
state: Ontario
city: Toronto
country: Canada
facility: University Health Network
state: Ontario
city: Montreal
country: Canada
facility: Hopital General Juif (Jewish General Hospital)
state: Quebec
city: Quebec City
country: Canada
facility: Institut Universitaire de Cardiologie et de Pneumologie de Quebec
state: Quebec
city: Santiago
country: Chile
facility: Instituto Nacional del Torax Teaching Dept
city: Santiago
country: Chile
facility: Clinica Tabancura- Cardiology Unit
city: Santiago
country: Chile
facility: Pontificia Universidad Catolica de Chile-Departmento De Enfermedades Cardiovasculares
city: Beijing
country: China
facility: Peking Union Medical College Hospital, Rheumatology Department
city: Beijing
country: China
facility: Cardiovascular Institute & Fuwai Hospital-Pulmonary Vascular Center
city: Beijing
country: China
facility: Beijing Shijitan Hospital
city: Guangzhou
country: China
facility: Guangdong General Hospital, Cardiology Department
city: Shanghai
country: China
facility: Renji Hospital, Rheumatology Department
city: Shanghai
country: China
facility: Renji Hospital, Cardiology Department
city: Shanghai
country: China
facility: Shanghai Pulmonary Hospital, Department of Pulmonary Circulation
city: Bogota
country: Colombia
facility: Fundacion Cardio Infantil
city: Bogota
country: Colombia
facility: Fundacion Clinica Shaio
city: Praha 2
country: Czechia
facility: Gen Faculty Hosp Prague Cardiology Clin
city: Arhus
country: Denmark
facility: Aarhus University Hospital , Cardiology
city: Copenhagen
country: Denmark
facility: Rigshospitalet, Hjertemedicinsk klinik - Cardiology
city: Bron cedex
country: France
facility: Hosp Pradel Lyon - Dpt Pneumology
city: Caen Cedex
country: France
facility: Hosp Cote de Nacre - Dpt Pneumology
city: Clamart
country: France
facility: Hosp A. Beclere - Dept Pulmo & Resp Intensive Care
city: Lille Cedex
country: France
facility: Hosp Huriez - Dpt Internal Medecine
city: Strasbourg
country: France
facility: Hosp Civil - Dpt Pneumology
city: Toulouse Cedex 9
country: France
facility: Hosp Larrey - Dpt Pneumology
city: Berlin
country: Germany
facility: DRK Kliniken Köpenick
city: Dresden
country: Germany
facility: Universitätsklinikum Carl Gustav Carus, Medizinische Klinik1-Pneumologie/MK1-A13
city: Giessen
country: Germany
facility: "Justus-Liebig-Universität Gießen Zentrum für Innere Medizin Medizinische Klinik II"
city: Greifswald
country: Germany
facility: Universität Greifswald / Klinik für Innere Medizin B
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover / Klinik für Pneumologie
city: Heidelberg
country: Germany
facility: Thoraxklinik am Universitätsklinikum Heidelberg
city: Köln
country: Germany
facility: "Universitätsklinikum Köln Herzzentrum / Klinik III für Innere Medizin (Kardiologie, Pneumologie, Angiologie und Intensivmedizin)"
city: Leipzig
country: Germany
facility: Praxis für Pneumologie und Allergologie
city: Löwenstein
country: Germany
facility: Klinik Löwenstein gGmbH, Medizinische Klinik 1, Pneumologie - Kardiologie
city: Regensburg
country: Germany
facility: Universitätsklinkum Regensburg / Innere Medizin II
city: Athens
country: Greece
facility: Onasseio Cardiosurgical Hospital
city: Budapest
country: Hungary
facility: "Gottsegen György Országos Kardiológiai Intézet, Felnőtt kardiológiai osztály"
city: Budapest
country: Hungary
facility: "Semmelweis Egyetem, Pulmonológiai Klinika"
city: Debrecen
country: Hungary
facility: Egészségügyi Járóbeteg Központ Kardiológiai Intézete - Debrecen
city: Pécs
country: Hungary
facility: "Pécsi Tudományegyetem Klinikai Központ,
city: Szeged
country: Hungary
facility: "Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ, II. sz. Belgyógyászati klinika és Kardiológiai központ"
city: Ahmedabad
country: India
facility: Sanjivani Hospitals - Department of Cardiology
city: Chennai
country: India
facility: Apollo Hospitals, Chennai
city: Chennai
country: India
facility: Frontier Lifeline Hospitals, Dr KM Cherian Heart Foundation, Chennai
city: Hyderabad
country: India
facility: CARE Hospitals Nampally, Cardiology Dep. Hyderabad
city: New Delhi
country: India
facility: Apollo Indraprastha Hospitals
city: Dublin
country: Ireland
facility: Mater Miscordiae University Hospital
city: Haifa
country: Israel
facility: Carmel Medical Center, Pulmonary Unit
city: Jerusalem
country: Israel
facility: Pulmonology Institute, Hadassah University Hospital at Ein Karem
city: Petach Tikvah
country: Israel
facility: Rabin Medical Centre - Pulmonology
city: Rehovot
country: Israel
facility: Kaplan Medical - Pulmonary Institute
city: Tel-Hashomer
country: Israel
facility: The Chaim Sheba Med Ctr -Pulmonology
city: Bologna
country: Italy
facility: Policlinico S. Orsola-Malpighi - Dipartimento Cardio-Toraco-Vascolare
city: Napoli
country: Italy
facility: Seconda Università Degli Studi di Napoli - Azienda Universitaria Policlinico - Dipartimento Assistenziale di medicina Generale, Angiologia, Endocrinologia, Epatogastroenterologia e Reumatologia - Unità Operativa di Reumatologia
city: Palermo
country: Italy
facility: ISMETT - Istituto Mediterraneo Trapianti e Terapie ad Alta Specializzazione - Dipartimento di Medicina - Divisione di Pneumologia
city: Incheon
country: Korea, Republic of
facility: Gil Medical Centre
city: Seoul
country: Korea, Republic of
facility: Seoul Nathional University Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System Dept of Cardiology
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center, Division of Cardiology
city: Seoul
country: Korea, Republic of
facility: "The Catholic University of Korea, Seoul St. Mary's Hospital Department of Cardiology"
city: Kuala Lumpur
country: Malaysia
facility: Institut Jantung Negara (National Heart Institute)
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubrian
city: Mexico City
country: Mexico
facility: Instituto Nacional de Cardiologia (INC) Ignacio Chavez
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum / Afdeling longziekten, secretariaat 4A 48
city: Maastricht
country: Netherlands
facility: Academisch Ziekenhuis Maastricht / Department of Pulmonary Diseases
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis afdeling Longziekten
city: Rotterdam
country: Netherlands
facility: Erasmus Medisch Centrum Rotterdam afdeling longziekten
city: Lima
country: Peru
facility: Hospital Nacional Edgardo Rebagliati / Unidad de Investigacion Cardiologia 2
city: Lima
country: Peru
facility: Instituto de Enfermedades Respiratorias Clinica San Gabriel
city: Gdańsk
country: Poland
facility: "Uniwersyteckie Centrum Kliniczne II Klinika Kardiologii i Elektroterapii Serca"
city: Krakow
country: Poland
facility: "Instytut Kardiologii Collegium Medium UJ Krakowski Szpital Specjalistyczny im Jana Pawła II Klinika Chorób Serca i Naczyń"
city: Warszawa
country: Poland
facility: "Instytut Gruźlicy i Chorób Płuc Klinika Chorób Wewnętrznych Klatki Piersiowej"
city: Łódź
country: Poland
facility: "Wojewódzki Specjalistyczny Szpital im. dr Władysława Biegańskiego Oddział Kardiologiczny, II Katedra i Klinika Kardiologii UM"
city: Bucharest
country: Romania
facility: "Institutul de Pneumologie "Marius Nasta", I. Clinica de Pneumoftiziologie"
city: Iasi
country: Romania
facility: "Spitalul Clinic de Pneumoftiziologie Iasi Sectia Clinica I de Pneumoftiziologie"
city: Barnaul
country: Russian Federation
facility: Municipal Medical Institution City Hospital #5
city: Ekaterinburg
country: Russian Federation
facility: Regional Clinical Hospital # 1
city: Kemerovo
country: Russian Federation
facility: Kemerovo Cardiology Dispensary / Kemerovo Regional Hospital
city: Moscow
country: Russian Federation
facility: Scientific Research Institute of Pulmonology of the Federal Medical and Biological Agency of Russia
city: Moscow
country: Russian Federation
facility: State Institution, "Institute fo Rheumatology of RAMS"
city: Moscow
country: Russian Federation
facility: The Institution of the Clinical Cardiology named after A. L. Myaskinov
city: Novosibirsk
country: Russian Federation
facility: Limited liability company, Consultative diagnostic centre Healthy Joints
city: St Petersburg
country: Russian Federation
facility: V. A. Almazov Institute of Cardiology, Russian Ministry of Healthcare and Social Development / Medical Treatment and Rehabilitation Complex
city: Tomsk
country: Russian Federation
facility: Cardiology Scientific Research Institute of Tomsk Scientific Center of RAMs, Siberian Branch / Cardiovascular Surgery Department
city: Tomsk
country: Russian Federation
facility: Tomsk Regional Clinical Hospital/ Pulmonology Unit
city: Belgrade
country: Serbia
facility: "Klinički Centar Srbije, Klinika za pulmologiju"
city: Belgrade
country: Serbia
facility: "Kliničko-bolnički centar Zemun, Kardiološko odeljenje"
city: Singapore
country: Singapore
facility: National Heart Centre (NHC) Singapore
city: Bratislava
country: Slovakia
facility: Národný ústav srdcových a cievnych chorôb, a.s. - NÚSCH a.s.
city: Barcelona
country: Spain
facility: Hosp Vall D'Hebron - Barcelona - Pneumology
city: Barcelona
country: Spain
facility: Clinic-Barcelona
city: Madrid
country: Spain
facility: Hospital 12 Octubre
city: Goteborg
country: Sweden
facility: Sahlgrenska Universitetssjukhuset, Kardiologi
city: Linköping
country: Sweden
facility: Linköping University Hospital, Cardiology
city: Umea
country: Sweden
facility: Umeå University Hospital, Cardiology (Umeå)
city: Uppsala
country: Sweden
facility: Uppsala Akademiska Sjukhuset, Kardiologkliniken 50F
city: Basel
country: Switzerland
facility: University Hospital Basel Division of Pneumology
city: Bern
country: Switzerland
facility: Universitätsspital Bern, Clinic for Pneumology (Inselspital)
city: Genève 14
country: Switzerland
facility: HUG Hôpitaux Universitaires de Genève; Pneumology, PAH
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen Klinik für Pneumologie
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Veterans General Hospital (KVGH)
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital / Department of Surgery
city: Khon Kaen
country: Thailand
facility: Srinagarind Hospital, Khon Kaen University, Division of Allergy-Immunology and Rheumatology, Department of Medicine
city: Adana
country: Turkey
facility: Çukurova Üniversitesi Tıp Fakültesi Kardiyoloji Anabilim Dalı
city: Istanbul
country: Turkey
facility: Istanbul Üniversitesi Kardiyoloji Enstitisü
city: Istanbul
country: Turkey
facility: Marmara Üniversitesi Tip Fakultesi Kardiyoloji Anabilim Dali
city: İzmir
country: Turkey
facility: Dokuz Eylül Üniversitesi Tıp Fakültesi Kardiyoloji Anabilim Dalı
city: Dnipropetrovsk
country: Ukraine
facility: "Dnipropetrovsk State Medical Academy, Municipal Institution ""Dnipropetrovsk Regional Clinic Diagnostic Center""
city: Kharkiv
country: Ukraine
facility: Health Care Municipal Institution, City Clinical Hospital #13
city: Kyiv
country: Ukraine
facility: Public Institution "F.H. Yanovski Phthisiology and Pulmonology National Institute Under Ukrainian Academy of Medical Sciences"
city: Lviv
country: Ukraine
facility: Lviv Regional Clinical Hospital
city: Glasgow
country: United Kingdom
facility: Golden Jubilee - Pulm Vascular Unit
city: London
country: United Kingdom
facility: Royal Free & Ucms Rheumatology Unit
city: London
country: United Kingdom
facility: Hammersmith
Study officials:
affiliation: Actelion
name: Aline Frey
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.