Selexipag (ACT-293987) in Pulmonary Arterial Hypertension (GRIPHON)

October 10, 2025 updated by: Actelion

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1156

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1119ACN
        • Centro de Investigacion y Prevencion Cardiovascular (CIPREC)
      • Buenos Aires, Argentina, C1121ABL
        • Sanatorio Otamendi y Miroli S.A.
      • Buenos Aires, Argentina, C1280AEB
        • Hospital Britanico-Pneumology
      • Buenos Aires, Argentina, C1425DUH
        • Sanatorio San Jose
      • Corrientes, Argentina, W3400AMZ
        • Instituto de Cardiologia de Corrientes
      • Córdoba, Argentina, X5016KEH
        • Hospital Privado Centro Medico de Cordoba S.A.
  • Australia
      • Hobart, Australia, TAS 7000
        • Royal Hobart Hospital, Centre for Clinical Research
      • New Lambton, Australia, 2305
        • John Hunter Hospital Autoimmune Resource and Research Centre
      • Parkville, Australia, VIC 3050
        • Royal Melbourne Hospital, Department of Respiratory and Sleep Medicine
      • Perth, Australia, 6000
        • Royal Perth Hospital
    • New South Wales
      • Darlinghurst, New South Wales, Australia, 2010
        • St. Vincent's Hospital / Heart and Lung Transplant Unit
    • Queensland
      • Chermside, Queensland, Australia, 4032
        • Prince Charles Hospital Lung Transplant, Thoracic Department
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital, Cardiovascular Investigation Unit (CVIU)
      • Bedford Park, South Australia, Australia, 5042
        • Flinders Medical Centre, Pulmonary Hypertension, c/- Cardiology
    • Victoria
      • Fitzroy, Victoria, Australia, 3065
        • St Vincent's Hospital
  • Austria
      • Graz, Austria, 8036
        • Medizinische Universität Graz
      • Vienna, Austria, A-1090
        • Medical University of Vienna and AKH Cardiology
  • Belarus
      • Minsk, Belarus, 220036
        • The Republican Scientific-Practical Center "Cardiology"
      • Minsk, Belarus, 220116
        • Minsk City Hospital No. 9
      • Minsk, Belarus, 223040
        • Minsk Regional Clinical Hospital of the Red Banner of Labour
  • Belgium
      • Brussels, Belgium, 1070
        • Ulb Erasme, Cardiology
      • Leuven, Belgium, 3000
        • University Hospital Gasthuisberg - Pneumologie
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G2C8
        • University of Alberta Hospital - Children's Centre
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R8
        • Health Sciences Centre
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • University of Ottawa Heart Institute
      • Toronto, Ontario, Canada, M5G 2N2
        • University Health Network
    • Quebec
      • Montreal, Quebec, Canada, H3T 1E2
        • Hopital General Juif (Jewish General Hospital)
      • Québec, Quebec, Canada, G1V 4G5
        • Institut Universitaire de Cardiologie et de Pneumologie de Quebec
  • Chile
      • Santiago, Chile, 7500691
        • Instituto Nacional del Torax Teaching Dept
      • Santiago, Chile, 7650018
        • Clinica Tabancura- Cardiology Unit
      • Santiago, Chile, 8330074
        • Pontificia Universidad Catolica de Chile-Departmento De Enfermedades Cardiovasculares
  • China
      • Beijing, China, 100038
        • Beijing Shijitan Hospital
      • Beijing, China, 100032
        • Peking Union Medical College Hospital, Rheumatology Department
      • Beijing, China, 100037
        • Cardiovascular Institute & Fuwai Hospital-Pulmonary Vascular Center
      • Guangzhou, China, 510080
        • Guangdong General Hospital, Cardiology Department
      • Shanghai, China, 200001
        • Renji Hospital, Rheumatology Department
      • Shanghai, China, 200127
        • Renji Hospital, Cardiology Department
      • Shanghai, China, 200433
        • Shanghai Pulmonary Hospital, Department of Pulmonary Circulation
  • Colombia
      • Bogotá, Colombia
        • Fundación Clínica Shaio
      • Bogotá, Colombia
        • Fundacion Cardio Infantil
  • Czechia
      • Prague, Czechia, 128 08
        • Gen Faculty Hosp Prague Cardiology Clin
  • Denmark
      • Aarhus, Denmark, 8200
        • Aarhus University Hospital , Cardiology
      • Copenhagen, Denmark, 2100
        • Rigshospitalet, Hjertemedicinsk klinik - Cardiology
  • France
      • Bron, France, 69677
        • Hosp Pradel Lyon - Dpt Pneumology
      • Caen, France, 14033
        • Hosp Cote de Nacre - Dpt Pneumology
      • Clamart, France, 92140
        • Hosp A. Beclere - Dept Pulmo & Resp Intensive Care
      • Lille, France, 59037
        • Hosp Huriez - Dpt Internal Medecine
      • Strasbourg, France, 67091
        • Hosp Civil - Dpt Pneumology
      • Toulouse, France, 31059
        • Hosp Larrey - Dpt Pneumology
  • Germany
      • Berlin, Germany, 12559
        • DRK Kliniken Köpenick
      • Cologne, Germany, 50924
        • "Universitätsklinikum Köln Herzzentrum / Klinik III für Innere Medizin (Kardiologie, Pneumologie, Angiologie und Intensivmedizin)"
      • Dresden, Germany, 01307
        • Universitätsklinikum Carl Gustav Carus, Medizinische Klinik1-Pneumologie/MK1-A13
      • Giessen, Germany, 35392
        • "Justus-Liebig-Universität Gießen Zentrum für Innere Medizin Medizinische Klinik II"
      • Greifswald, Germany, 17487
        • Universität Greifswald / Klinik für Innere Medizin B
      • Hanover, Germany, 30625
        • Medizinische Hochschule Hannover / Klinik für Pneumologie
      • Heidelberg, Germany, 69126
        • Thoraxklinik am Universitatsklinikum Heidelberg
      • Leipzig, Germany, 04103
        • Praxis Für Pneumologie Und Allergologie
      • Löwenstein, Germany, 74245
        • Klinik Löwenstein gGmbH, Medizinische Klinik 1, Pneumologie - Kardiologie
      • Regensburg, Germany, 93053
        • Universitätsklinkum Regensburg / Innere Medizin II
  • Greece
      • Athens, Greece, 176 74
        • Onasseio Cardiosurgical Hospital
  • Hungary
      • Budapest, Hungary, 1125
        • "Semmelweis Egyetem, Pulmonológiai Klinika"
      • Budapest, Hungary, 1096
        • "Gottsegen György Országos Kardiológiai Intézet, Felnőtt kardiológiai osztály"
      • Debrecen, Hungary, 4032
        • Egészségügyi Járóbeteg Központ Kardiológiai Intézete - Debrecen
      • Pécs, Hungary, 7624
        • "Pécsi Tudományegyetem Klinikai Központ,
      • Szeged, Hungary, 6720
        • "Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ, II. sz. Belgyógyászati klinika és Kardiológiai központ"
  • India
      • Ahmedabad, India, 380015
        • Sanjivani Hospitals - Department of Cardiology
      • Chennai, India, 600006
        • Apollo Hospitals, Chennai
      • Chennai, India, 600101
        • Frontier Lifeline Hospitals, Dr KM Cherian Heart Foundation, Chennai
      • Hyderabad, India, 500001
        • CARE Hospitals Nampally, Cardiology Dep. Hyderabad
      • New Delhi, India, 110076
        • Apollo Indraprastha Hospitals
  • Ireland
      • Dublin, Ireland, Dublin 7
        • Mater Miscordiae University Hospital
  • Israel
      • Haifa, Israel, 34362
        • Carmel Medical Center, Pulmonary Unit
      • Jerusalem, Israel, 91120
        • Pulmonology Institute, Hadassah University Hospital at Ein Karem
      • Petach Tikvah, Israel, 49100
        • Rabin Medical Centre - Pulmonology
      • Rehovot, Israel, 76100
        • Kaplan Medical - Pulmonary Institute
      • Tel Litwinsky, Israel, 52621
        • The Chaim Sheba Med Ctr -Pulmonology
  • Italy
      • Bologna, Italy, 40138
        • Policlinico S. Orsola-Malpighi - Dipartimento Cardio-Toraco-Vascolare
      • Napoli, Italy, 80131
        • Seconda Università Degli Studi di Napoli - Azienda Universitaria Policlinico - Dipartimento Assistenziale di medicina Generale, Angiologia, Endocrinologia, Epatogastroenterologia e Reumatologia - Unità Operativa di Reumatologia
      • Palermo, Italy, 90127
        • ISMETT - Istituto Mediterraneo Trapianti e Terapie ad Alta Specializzazione - Dipartimento di Medicina - Divisione di Pneumologia
  • Malaysia
      • Kuala Lumpur, Malaysia, 50400
        • Institut Jantung Negara (National Heart Institute)
  • Mexico
      • Mexico City, Mexico, 14080
        • Instituto Nacional de Cardiologia (INC) Ignacio Chavez
      • Mexico City, Mexico, 14000
        • Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubrian
  • Netherlands
      • Amsterdam, Netherlands, 1081 HV
        • VU Medisch Centrum / Afdeling longziekten, secretariaat 4A 48
      • Maastricht, Netherlands, 6229 HX
        • Academisch Ziekenhuis Maastricht / Department of Pulmonary Diseases
      • Nieuwegein, Netherlands, 3430 EM
        • St. Antonius Ziekenhuis afdeling Longziekten
      • Rotterdam, Netherlands, 3015 GD
        • Erasmus Medisch Centrum Rotterdam afdeling longziekten
  • Peru
      • Lima, Peru, 11
        • Hospital Nacional Edgardo Rebagliati / Unidad de Investigacion Cardiologia 2
      • Lima, Peru, 32
        • Instituto de Enfermedades Respiratorias Clinica San Gabriel
  • Poland
      • Gdansk, Poland, 80-952
        • "Uniwersyteckie Centrum Kliniczne II Klinika Kardiologii i Elektroterapii Serca"
      • Krakow, Poland, 31-202
        • "Instytut Kardiologii Collegium Medium UJ Krakowski Szpital Specjalistyczny im Jana Pawła II Klinika Chorób Serca i Naczyń"
      • Lodz, Poland, 91-347
        • "Wojewódzki Specjalistyczny Szpital im. dr Władysława Biegańskiego Oddział Kardiologiczny, II Katedra i Klinika Kardiologii UM"
      • Warsaw, Poland, 01-138
        • "Instytut Gruźlicy i Chorób Płuc Klinika Chorób Wewnętrznych Klatki Piersiowej"
  • Romania
      • Bucharest, Romania, 050159
        • "Institutul de Pneumologie "Marius Nasta", I. Clinica de Pneumoftiziologie"
      • Iași, Romania, 700115
        • "Spitalul Clinic de Pneumoftiziologie Iasi Sectia Clinica I de Pneumoftiziologie"
  • Russia
      • Barnaul, Russia, 656045
        • Municipal Medical Institution City Hospital #5
      • Kemerovo, Russia, 650044
        • Kemerovo Cardiology Dispensary / Kemerovo Regional Hospital
      • Moscow, Russia, 105077
        • Scientific Research Institute of Pulmonology of the Federal Medical and Biological Agency of Russia
      • Moscow, Russia, 115552
        • State Institution, "Institute fo Rheumatology of RAMS"
      • Moscow, Russia, 121552
        • The Institution of the Clinical Cardiology named after A. L. Myaskinov
      • Novosibirsk, Russia, 630091
        • Limited liability company, Consultative diagnostic centre Healthy Joints
      • Saint Petersburg, Russia, 194156
        • V. A. Almazov Institute of Cardiology, Russian Ministry of Healthcare and Social Development / Medical Treatment and Rehabilitation Complex
      • Tomsk, Russia, 634012
        • Cardiology Scientific Research Institute of Tomsk Scientific Center of RAMs, Siberian Branch / Cardiovascular Surgery Department
      • Tomsk, Russia, 634063
        • Tomsk Regional Clinical Hospital/ Pulmonology Unit
      • Yekaterinburg, Russia, 620102
        • Regional Clinical Hospital # 1
  • Serbia
      • Belgrade, Serbia, 11000
        • "Klinički Centar Srbije, Klinika za pulmologiju"
      • Belgrade, Serbia, 11080
        • "Kliničko-bolnički centar Zemun, Kardiološko odeljenje"
  • Singapore
      • Singapore, Singapore, 168752
        • National Heart Centre (NHC) Singapore
  • Slovakia
      • Bratislava, Slovakia, 833 48
        • Národný ústav srdcových a cievnych chorôb, a.s. - NÚSCH a.s.
  • South Korea
      • Incheon, South Korea, 405-760
        • Gil Medical Centre
      • Seoul, South Korea, 110-744
        • Seoul Nathional University Hospital
      • Seoul, South Korea, 120-752
        • Yonsei University Health System Dept of Cardiology
      • Seoul, South Korea, 135-710
        • Samsung Medical Center, Division of Cardiology
      • Seoul, South Korea, 137-701
        • "The Catholic University of Korea, Seoul St. Mary's Hospital Department of Cardiology"
  • Spain
      • Barcelona, Spain, 8035
        • Hosp Vall D'Hebron - Barcelona - Pneumology
      • Barcelona, Spain, 8036
        • Clinic-Barcelona
      • Madrid, Spain, 28041
        • Hospital 12 Octubre
  • Sweden
      • Gothenburg, Sweden, SE-413 45
        • Sahlgrenska Universitetssjukhuset, Kardiologi
      • Linköping, Sweden, 58185
        • Linköping University Hospital, Cardiology
      • Umeå, Sweden, 90185
        • Umeå University Hospital, Cardiology (Umeå)
      • Uppsala, Sweden, 751 85
        • Uppsala Akademiska Sjukhuset, Kardiologkliniken 50F
  • Switzerland
      • Basel, Switzerland, 4031
        • University Hospital Basel Division of Pneumology
      • Bern, Switzerland, 3010
        • Universitätsspital Bern, Clinic for Pneumology (Inselspital)
      • Geneva, Switzerland, 1211
        • HUG Hôpitaux Universitaires de Genève; Pneumology, PAH
      • Sankt Gallen, Switzerland, 9007
        • Kantonsspital St. Gallen Klinik für Pneumologie
  • Taiwan
      • Kaohsiung City, Taiwan
        • Kaohsiung Veterans General Hospital (KVGH)
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital / Department of Surgery
  • Thailand
      • Khon Kaen, Thailand, 40002
        • Srinagarind Hospital, Khon Kaen University, Division of Allergy-Immunology and Rheumatology, Department of Medicine
  • Turkey (Türkiye)
      • Adana, Turkey (Türkiye), 01330
        • Çukurova Üniversitesi Tıp Fakültesi Kardiyoloji Anabilim Dalı
      • Istanbul, Turkey (Türkiye), 34096
        • Istanbul Üniversitesi Kardiyoloji Enstitisü
      • Istanbul, Turkey (Türkiye), 34899
        • Marmara Üniversitesi Tip Fakultesi Kardiyoloji Anabilim Dali
      • Izmir, Turkey (Türkiye), 35210
        • Dokuz Eylül Üniversitesi Tıp Fakültesi Kardiyoloji Anabilim Dalı
  • Ukraine
      • Dnipropetrovsk, Ukraine, 49060
        • "Dnipropetrovsk State Medical Academy, Municipal Institution ""Dnipropetrovsk Regional Clinic Diagnostic Center""
      • Kharkiv, Ukraine, 61124
        • Health Care Municipal Institution, City Clinical Hospital #13
      • Kyiv, Ukraine, 03680
        • Public Institution "F.H. Yanovski Phthisiology and Pulmonology National Institute Under Ukrainian Academy of Medical Sciences"
      • Lviv, Ukraine, 79010
        • Lviv Regional Clinical Hospital
  • United Kingdom
      • Glasgow, United Kingdom, G81 4HX
        • Golden Jubilee - Pulm Vascular Unit
      • London, United Kingdom, NW3 2QG
        • Royal Free & Ucms Rheumatology Unit
      • London, United Kingdom, W12 0HS
        • Hammersmith
  • United States
    • Alabama
      • Mobile, Alabama, United States, 36617
        • University of South Alabama
    • Arizona
      • Tucson, Arizona, United States, 85704
        • The University of Arizona, Clinical and Translational Science (CATS) Research Center
    • California
      • La Jolla, California, United States, 92037
        • University of California San Diego Medical Center (La Jolla)
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • Los Angeles, California, United States, 90073
        • GLVA Healthcare Center
      • Sacramento, California, United States, 95817
        • University of California, Davis, UC Davis Medical Center
      • Torrance, California, United States, 90502-2006
        • LIU Center for Pulmonary Hypertension
    • Delaware
      • Newark, Delaware, United States, 19713
        • Lung Health & Sleep Emhancement Center, LLC
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University School of Medicine, Division of Pulmonary, Allergy and Critical Care Medicine
      • Augusta, Georgia, United States, 30912-3135
        • Georgia Health Sciences University
      • Austell, Georgia, United States, 30106
        • Georgia Clinical Research
    • Indiana
      • Carmel, Indiana, United States, 46032
        • Clarian North Hospital
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals & Clinics
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • Kentuckiana Pulmonary Associates
    • Louisiana
      • New Orleans, Louisiana, United States, 70112
        • LSU Health Science Center - New Orleans
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University School of Medicine
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center
      • Boston, Massachusetts, United States, 02118
        • Boston University School of Medicine / Boston University Medical Center
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital - Pulmonary Critical Care Unit
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital-Pulmonary Critical Care Unit
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan
      • Detroit, Michigan, United States, 48202
        • Henry Ford Hospital
      • Troy, Michigan, United States, 48307
        • Beaumont Hospital
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • New Jersey
      • Newark, New Jersey, United States, 07112
        • Newark Beth Isreal Medical Center-Department of Pulmonary Medicine
    • New York
      • New York, New York, United States, 10032
        • Columbia University Medical Center, Pediatric Cardiology
      • The Bronx, New York, United States, 10461
        • Montefiore Medical Center, Weiler Division
    • North Carolina
      • Durham, North Carolina, United States, 27710-0001
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45267
        • University of Cincinnati
      • Cincinnati, Ohio, United States, 45219-2906
        • The Lindner Clinical Trial Center
      • Cleveland, Ohio, United States, 44106
        • University Hospitals Case Medical Center
      • Columbus, Ohio, United States, 43221
        • The Ohio State University Medical Center
    • Oregon
      • Portland, Oregon, United States, 97225
        • Oregon Pulmonary Associates, PC
    • Pennsylvania
      • Doylestown, Pennsylvania, United States, 18901
        • Central Bucks Specialists
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University Hospital
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn Presbyterian Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232-2386
        • Vanderbilt Medical Center
    • Texas
      • Dallas, Texas, United States, 75390
        • UT Southwestern Medical Center at Dallas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine
      • Houston, Texas, United States, 77030
        • University of Texas-Houston Health Center Department of Pulmonary & Critical Care
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospital-Department of Medicine
      • Milwaukee, Wisconsin, United States, 53226
        • Froedtert Hospital - Medical College of Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • St. Luke's Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Drug: Selexipag
Selexipag 200 µg tablets
Other Names:
  • ACT-293987
Placebo Comparator: 2
Matching placebo is administered orally with a dosing interval of approximately12 h. A (mock) up-titration scheme is followed
Drug: Placebo
Placebo tablets matching selexipag

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time From Randomization to the First Morbidity Event or Death (All Causes) up to 7 Days After the Last Study Drug Intake
Time Frame: Up to 7 days after end of double-blind treatment (maximum: 4.3 years)

Time from randomization to the first occurrence of a morbidity event or death (all causes) was analyzed with the Kaplan-Meier method (event-free KM estimates at different time points).

Morbidity event was defined as any of the following events confirmed by the Critical Event committee:

  • Hospitalization for worsening of pulmonary arterial hypertension (PAH),
  • Worsening of PAH resulting in need for lung transplantation or balloon atrial septostomy,
  • Initiation of parenteral prostanoid therapy or chronic oxygen therapy due to worsening of PAH,
  • Disease progression which was defined by a decrease in 6-minute walk distance from baseline (>=15%, confirmed by a 2nd test on a different day) combined with worsening of WHO FC for patients belonging to WHO FC II/III at baseline, or combined with the need for additional PAH-specific therapy for patients belonging to WHO FC III/IV at baseline.

Note: The number of patients at risk decreased over time but this cannot be captured below
Up to 7 days after end of double-blind treatment (maximum: 4.3 years)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline to Week 26 in 6-minute Walk Distance (6MWD) at Trough
Time Frame: Week 26
The 6-minute walk distance test (6MWD) is a non-encouraged test performed in a 30 m long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones, with the permission to slow down, rest, or stop if needed. If the patient was used to taking bronchodilators before a walk, he/she was given them 5 to 30 min before the test. Also if the patient was on chronic oxygen therapy, oxygen was given at their standard rate during the test. Absolute change from baseline to Week 26 in 6MWD was measured at trough, i.e., either on the next day after the last study drug administration or at least 12 hours after study drug administration if on the same day.
Week 26
Absence of Worsening From Baseline to Week 26 in Modified NYHA/WHO Functional Class (WHO FC)
Time Frame: Week 26
Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Actelion

Investigators

  • Study Director: Aline Frey, Actelion

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2009

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

April 2, 2010

First Submitted That Met QC Criteria

April 16, 2010

First Posted (Estimated)

April 19, 2010

Study Record Updates

Last Update Posted (Estimated)

October 27, 2025

Last Update Submitted That Met QC Criteria

October 10, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AC-065A302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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