ACT-293987 in Pulmonary Arterial Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01112306
Recruitment Status : Active, not recruiting
First Posted : April 28, 2010
Last Update Posted : March 13, 2018
Information provided by (Responsible Party):

Brief Summary:
Long-term, single-arm, multicenter, open-label extension, Phase 3 study, to evaluate the safety and tolerability of ACT-293987 in patients with PAH who participated in the double-blind study AC-065A302 (GRIPHON)

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: ACT-293987 Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 670 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Long-term Single-arm Open-label Study, to Assess the Safety and Tolerability of Selexipag (ACT-293987) in Patients With Pulmonary Arterial Hypertension
Study Start Date : December 1, 2009
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : February 1, 2021

Arm Intervention/treatment
Experimental: 1
ACT-293987, twice daily
Drug: ACT-293987
Tablets, twice daily

Primary Outcome Measures :
  1. Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Up to end of study. The duration of the study will be country-dependent and based on the results of the AC-065A302 study. ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients who participated to the double-blind study AC-065A302 and either had a morbidity event or had completed the study as scheduled per protocol.
  • Signed informed consent.

Exclusion Criteria:

  • Patients who have started receiving prostacyclin (epoprostenol) or prostacyclin analogs (i.e., treprostinil, iloprost, beraprost) since the last study drug intake in AC-065A302/GRIPHON.
  • Severe hepatic impairment (Child-Pugh C).
  • Females who are pregnant or who plan to become pregnant during the study, or are breastfeeding.
  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01112306

  Hide Study Locations
United States, Arizona
The University of Arizona, Clinical and Translational Science (CATS) Research Center
Tucson, Arizona, United States, 85724
United States, California
University of California San Diego Medical Center (La Jolla)
La Jolla, California, United States, 92093-0052
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
GLVA Healthcare Center
Los Angeles, California, United States, 90073
University of California, Davis, UC Davis Medical Center
Sacramento, California, United States, 95817
LIU Center for Pulmonary Hypertension
Torrance, California, United States, 90502-2006
United States, Delaware
Christiana Care Health Services
Newark, Delaware, United States, 19713
United States, Georgia
Emory University School of Medicine, Division of Pulmonary, Allergy and Critical Care Medicine
Atlanta, Georgia, United States, 30322
Georgia Regents Univ/ Augusta Univ
Augusta, Georgia, United States, 30912-3135
Piedmont Healthcare Pulm & Crit Care Research
Austell, Georgia, United States, 30106
United States, Kentucky
Kentuckiana Pulmonary Associates
Louisville, Kentucky, United States, 40202
United States, Louisiana
LSU Health Science Center - New Orleans
New Orleans, Louisiana, United States, 70112-1393
United States, Maryland
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111-1552
Boston University School of Medicine / Boston University Medical Center
Boston, Massachusetts, United States, 02118
United States, Michigan
University of Michigan
Ann Arbor, Michigan, United States, 48109
Henry Ford Hospital
Detroit, Michigan, United States, 48202
William Beaumont Hospital
Troy, Michigan, United States, 48307
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110-1010
United States, New Jersey
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
United States, New York
Montefiore Medical Center, Weiler Division
Bronx, New York, United States, 10461
Columbia University Medical Center, Pediatric Cardiology
New York, New York, United States, 10032
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710-0001
United States, Ohio
The Lindner Clinical Trial Center
Cincinnati, Ohio, United States, 45219-2906
The Ohio State University Medical Center
Columbus, Ohio, United States, 43210
United States, Oregon
Oregon Pulmonary Associates, PC
Portland, Oregon, United States, 97225-6640
United States, Pennsylvania
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States, 19107
United States, Tennessee
Vanderbilt Medical Center
Nashville, Tennessee, United States, 37232-2386
United States, Texas
UT Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390-8550
Baylor College of Medicine, Houston Methodist Hospital
Houston, Texas, United States, 77030
University of Texas-Houston Health Center Department of Pulmonary & Critical Care
Houston, Texas, United States, 77030
United States, Wisconsin
University of Wisconsin Hospital-Department of Medicine
Madison, Wisconsin, United States, 53792-2442
Froedtert Hospital, Pulm & Critical Care
Milwaukee, Wisconsin, United States, 53226
St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53233
Centro de Investigacion y Prevencion Cardiovascular (CIPREC)
Buenos Aires, Argentina, C1119ACN
Sanatorio Otamendi y Miroli S.A.
Buenos Aires, Argentina, C1121ABL
Servicio de Dialisis y Nefrologia
Buenos Aires, Argentina, C1182ADA
Hospital Britanico-Pneumology
Buenos Aires, Argentina, C1280AEB
Hospital Privado Centro Medico de Cordoba S.A.
Cordoba, Argentina, X5016KEH
Instituto De Cardiologia de Corrientes
Corrientes, Argentina, W3400AMZ
Australia, New South Wales
St. Vincent's Hospital / Heart and Lung Transplant Unit
Darlinghurst, New South Wales, Australia, 2010
John Hunter Hospital Autoimmune Resource and Research Centre
New Lambton, New South Wales, Australia, 2305
Australia, Queensland
Prince Charles Hospital Lung Transplant, Thoracic Department
Chermside, Queensland, Australia, 4032
Australia, South Australia
Royal Adelaide Hospital, Cardiovascular Investigation Unit (CVIU)
Adelaide, South Australia, Australia, 5000
Flinders Medical Centre, Pulmonary Hypertension, c/o Cardiology Department
Bedford Park, South Australia, Australia, 5042
Australia, Tasmania
Royal Hobart Hospital, Centre for Clinical Research
Hobart, Tasmania, Australia, 7000
Australia, Victoria
St Vincent's Hospital, Department of Rheumatology
Fitzroy, Victoria, Australia, 3065
Royal Melbourne Hospital, Department of Respiratory and Sleep Medicine
Parkville, Victoria, Australia, 3050
Australia, Western Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia, 6150
Medical University of Vienna and AKH Cardiology
Vienna, Austria, 1090
The Republican Scientific-Practical Center "Cardiology"
Minsk, Belarus, 220036
9th City Clinical Hospital
Minsk, Belarus, 220116
Minsk Regional Clinical Hospital of the Red Banner of Labour
Minsk, Belarus, 223041
Ulb Erasme, Cardiology
Brussels, Belgium, 1070
Hosp Uzl - Pneumology Dept
Leuven, Belgium, 3000
Canada, Alberta
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Canada, British Columbia
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Manitoba
Health Sciences Centre
Winnipeg, Manitoba, Canada, R3A 1R8
Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2N2
Canada, Quebec
Hopital General Juif (Jewish General Hospital)
Montreal, Quebec, Canada, H3T 1E2
Institut Universitaire de Cardiologie et de Pneumologie Hosp Laval
Quebec City, Quebec, Canada, G1V 4G5
Asesorias E Investigaciones Medicas Tasol Ltda
Santiago, Chile, 7500710
Pontificia Universidad Catolica de Chile-Departmento De Enfermedades Cardiovasculares
Santiago, Chile, 833034
Hospital San juan de Dios - Hemodinamia Lab.
Santiago, Chile, 8350488
Peking Union Medical College Hospital, Rheumatology Department
Beijing, China, 100032
Cardiovascular Institute & Fuwai Hospital-Pulmonary Vascular Center
Beijing, China, 100037
Beijing Shijitan Hospital
Beijing, China, 100038
Guangdong General Hospital, Cardiology Department
Guangzhou, China, 510080
Renji Hospital, Rheumatology Department
Shanghai, China, 200001
Renji Hospital, Cardiology Department
Shanghai, China, 200127
Shanghai Pulmonary Hospital, Department of Pulmonary Circulation
Shanghai, China, 200433
Fundacion Cardio Infantil
Bogota, Colombia
Fundacion Clinica Shaio
Bogota, Colombia
Gen Faculty Hosp Prague Ii Internal Clin
Praha 2, Czechia, 128 08
Aarhus University Hospital , Cardiology
Arhus, Denmark, 8200
"Hôpital Kremlin Bicêtre Service de Pneumologie - Réanimation respiratoire Centre de Référence de l'Hypertension Pulmonaire Sévère"
Le Kremlin-Bicêtre cedex, France, 94275
"CHRU de Lille - Hôpital Claude Huriez Service de médecine interne"
Lille Cedex, France, 59037
"CHU de Toulouse - Hopital Larrey Service de Pneumologie"
Toulouse Cedex 9, France, 31059
DRK Kliniken Berlin Westend
Berlin, Germany, 14050
Universitätsklinikum Carl Gustav Carus, Medizinische Klinik1-Pneumologie/MK1-A13
Dresden, Germany, 01307
Universitätsklinikum Giessen - Pneumologie
Giessen, Germany, 35392
Universität Greifswald / Klinik für Innere Medizin B
Greifswald, Germany, 17475
Medizinische Hochschule Hannover / Klinik für Pneumologie
Hannover, Germany, 30625
Thoraxklinik am Universitätsklinikum Heidelberg
Heidelberg, Germany, 69126
"Universitätsklinikum Köln Herzzentrum / Klinik III für Innere Medizin (Kardiologie, Pneumologie, Angiologie und Intensivmedizin)"
Köln, Germany, 50924
Praxis für Pneumologie und Allergologie
Leipzig, Germany, 04103
Universitätsklinkum Regensburg / Innere Medizin II
Regensburg, Germany, 93053
Onasseio Cardiosurgical Hospital
Athens, Greece, 176 74
Semmelweis Egyetem, Pulmonológiai Klinika, Cardio Dep
Budapest, Hungary, 1125
Debrecen, Hungary, 4032
Pécsi Tudományegyetem Klinikai Központ, Szívgyógyászati Klinika
Pécs, Hungary, 7624
"Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ, II. sz. Belgyógyászati klinika és Kardiológiai központ"
Szeged, Hungary, 6720
Sanjivani Hospitals - Department of Cardiology
Ahmedabad, India, 380015
Apollo Hospital
Chennai, India, 600006
Frontier Lifeline - Dr. K.M. Cherian Heart Foundation
Chennai, India, 600101
Care Hospital
Hyderabad, India, 500001
Mater Miscordiae University Hospital
Dublin, Ireland, Dublin 7
Carmel Medical Center, Pulmonary Unit
Haifa, Israel, 34362
Pulmonology Institute, Hadassah University Hospital at Ein Karem
Jerusalem, Israel, 9112001
Cardiology Department, Heart Failure Unit
Petach Tikvah, Israel, 49100
Kaplan Medical Centre / Pulmonary Institute and Department of Medicine
Rehovot, Israel, 76100
The Chaim Sheba Med Ctr -Pulmonology
Tel-Hashomer, Israel, 52621
Policlinico S. Orsola-Malpighi - Dipartimento Cardio-Toraco-Vascolare
Bologna, Italy, 40138
ISMETT - Istituto Mediterraneo Trapianti e Terapie ad Alta Specializzazione - Dipartimento di Medicina - Divisione di Pneumologia
Palermo, Italy, 90127
Korea, Republic of
Gacheon University Gil Medical Center
Incheon, Korea, Republic of, 21565
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Severance Hospital, YonSei University Health System
Seoul, Korea, Republic of, 03722
Samsung Medical Center
Seoul, Korea, Republic of, 06351
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, Korea, Republic of, 06591
The Catholic University of Korea, Yeouido St. Mary's Hospital
Seoul, Korea, Republic of, 07345
Institut Jantung Negara (National Heart Institute)
Kuala Lumpur, Malaysia, 50400
Instituto Nacional de Cardiologia (INC) Ignacio Chavez
Mexico City, Mexico, 14080
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubrian
Mexico D.F., Mexico, 14000
VU medisch centrum
Amsterdam, Netherlands, 1081 HV
Maastricht University Medical Center+ / Department of Pulmonary Diseases
Maastricht, Netherlands, 6229 HX
Erasmus Medisch Centrum Rotterdam afdeling longziekten
Rotterdam, Netherlands, 3015 CE
Hospital Nacional Edgardo Rebagliati / Unidad de Investigacion Cardiologia 2
Lima, Peru, 11
Instituto de Enfermedades Respiratorias Clinica San Gabriel
Lima, Peru, 32
"Instytut Kardiologii Collegium Medium UJ Krakowski Szpital Specjalistyczny im Jana Pawła II Klinika Chorób Serca i Naczyń"
Krakow, Poland, 31-202
Cardiology Otwock Priv
Otwock, Poland, 05-400
"Wojewódzki Specjalistyczny Szpital im. dr Władysława Biegańskiego Oddział Kardiologiczny, II Katedra i Klinika Kardiologii UM"
Łódź, Poland, 91-347
"Institutul de Pneumologie "Marius Nasta", I. Clinica de Pneumoftiziologie"
Bucharest, Romania, 050159
Russian Federation
Regional Clinical Hospital # 1/ Cardiology Department (2nd Therapy Department)
Ekaterinburg, Russian Federation, 620102
Sci Institute Systemic Problems Cardio Diseases Kemerovo
Kemerovo, Russian Federation, 650002
Scientific Research Institute of Pulmonology
Moscow, Russian Federation, 105077
RAMS Institution "Scientific Institute of Rheumatology of RAMS"
Moscow, Russian Federation, 115552
The Institution of the Clinical Cardiology named after A. L. Myaskinov / Arterial Hypertension Department, Cardiology Research Complex Ministry of Hea
Moscow, Russian Federation, 121552
Novosibirsk City Clinical Polyclinic #1
Novosibirsk, Russian Federation, 630005
V. A. Almazov Institute of Cardiology, Russian Ministry of Healthcare and Social Development / Medical Treatment and Rehabilitation Complex
St Petersburg, Russian Federation, 197341
Cardiology Scientific Research Institute of Tomsk Scientific Center of RAMs, Siberian Branch / Cardiovascular Surgery Department
Tomsk, Russian Federation, 634012
Tomsk Regional Clinical Hospital/ Pulmonology Unit
Tomsk, Russian Federation, 634063
"Klinički Centar Srbije, Klinika za pulmologiju"
Belgrade, Serbia, 11000
"Kliničko-bolnički centar Zemun, Kardiološko odeljenje"
Belgrade, Serbia, 11080
National Heart Centre (NHC) Singapore
Singapore, Singapore, 169609
"Národný ústav srdcových a cievnych chorôb, a.s. - NÚSCH a.s. Oddelenie zlyhávania a transplantácie"
Bratislava 37, Slovakia, 833 48
Hospital Universitario VALL D'HEBRON
Barcelona, Spain, 08035
Hospital Clinico i provincial Barcelona, Dpt Pneumology
Barcelona, Spain, 08036
Hospital Universitario12 Octubre, Servicio de Cardiología
Madrid, Spain, 28041
Sahlgrenska Universitetssjukhuset, Kardiologi
Goteborg, Sweden, 413 45
Linköping University Hospital
Linkoping, Sweden, 58185
Norrlands universitetssjukhus, Hjärtcentrum
Umeå, Sweden, 901 85
Uppsala Akademiska Sjukhuset, Kardiologkliniken 50F
Uppsala, Sweden, 751 85
University Hospital Basel Division of Pneumology
Basel, Switzerland, 4031
HUG Hôpitaux Universitaires de Genève; Pneumology, PAH
Genève 14, Switzerland, 1211
Kaohsiung Veterans General Hospital / Intensive Care Unit
Kaohsiung, Taiwan, 81362
National Taiwan University Hospital / Department of Surgery
Taipei, Taiwan, 100
Srinagarind Hospital, Khon Kaen University, Division of Allergy-Immunology and Rheumatology, Department of Medicine
Khon Kaen Province, Thailand, 40002
Çukurova Üniversitesi Tıp Fakültesi Kardiyoloji Anabilim Dalı
Adana, Turkey, 01330
Marmara Üniversitesi Tip Fakultesi Kardiyoloji Anabilim Dali
Istanbul, Turkey, 34899
Dnipropetrovsk Medical Academy
Dnipro, Ukraine, 49070
City Clinical Hospital #13
Kharkiv, Ukraine, 61035
State Institute of phthisiology and pulmonology n.a. F.G. yanovskiy of AMS Ukraine
Kyiv, Ukraine, 03680
Lviv Regional Clinical Hospital, Cardiosurgery Department
Lviv, Ukraine, 79014
United Kingdom
Golden Jubilee - Pulm Vascular Unit
Glasgow, United Kingdom, G81 4DY
The Royal Free Hospital, Department of Rheumatology, Royal Free London NHS Foundation Trust
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
Study Director: Aline Frey Actelion

Responsible Party: Actelion Identifier: NCT01112306     History of Changes
Other Study ID Numbers: AC-065A303
First Posted: April 28, 2010    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018

Keywords provided by Actelion:
Pulmonary Arterial Hypertension

Additional relevant MeSH terms:
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Antihypertensive Agents