ACT-293987 in Pulmonary Arterial Hypertension

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01112306
First received: April 8, 2010
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Pulmonary Arterial Hypertension
Drug: ACT-293987
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 670
Study Start Date: December 2009
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
ACT-293987, twice daily
Drug: ACT-293987
tablets, twice daily

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01112306

  Hide Study Locations
Locations
United States, Alabama
University of South Alabama
Mobile, Alabama, United States, 36617
United States, Arizona
The University of Arizona, Clinical and Translational Science (CATS) Research Center
Tuscon, Arizona, United States, 85704
United States, California
University of California San Diego Medical Center (La Jolla)
La Jolla, California, United States, 90237
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
Lung Health & Sleep Emhancement Center, LLC
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
Medical College of Georgia
Augusta, Georgia, United States, 30912-3135
Georgia Clinical Research
Georgia, Georgia, United States, 30106
United States, Indiana
Clarian North Hospital
Carmel, Indiana, United States, 46032
United States, Iowa
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
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
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
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
Beaumont Hospital
Troy, Michigan, United States, 48307
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
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
University of Cincinnati
Cincinnati, Ohio, United States, 45267
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
The Ohio State University Medical Center
Columbus, Ohio, United States, 43221
United States, Oregon
Oregon Pulmonary Associates, PC
Portland, Oregon, United States, 97225
United States, Pennsylvania
Central Bucks Specialists
Doylestown, Pennsylvania, United States, 18901
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
University of Texas-Houston Health Center Department of Pulmonary & Critical Care
Houston, Texas, United States, 77030
Baylor College of Medicine
Houston, Texas, United States, 77030
United States, Wisconsin
University of Wisconsin Hospital-Department of Medicine
Madison, Wisconsin, United States, 53792
Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Argentina
Sanatorio San Jose
Buenos Aires, Argentina, C1425DUH
Sanatorio Otamendi y Miroli S.A.
Buenos Aires, Argentina, C1121ABL
Centro de Investigacion y Prevencion Cardiovascular (CIPREC)
Buenos Aires, Argentina, C1119ACN
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, 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
Australia, Victoria
St Vincent's Hospital, Department of Rheumatology
Fitzroy, Victoria, Australia, 3065
Australia
Flinders Medical Centre, Pulmonary Hypertension, c/o Cardiology Department
Bedford Park, Australia, SA 5042
St. Vincent's Hospital / Heart and Lung Transplant Unit
Darlinghurst, Australia, 2010
Royal Hobart Hospital, Centre for Clinical Research
Hobart, Australia, 7000
John Hunter Hospital Autoimmune Resource and Research Centre
New Lambton, Australia, 2305
Royal Melbourne Hospital, Department of Respiratory and Sleep Medicine
Parkville, Australia, VIC 3050
Royal Perth Hospital
Perth, Australia, 6000
Austria
Medizinische Universität Graz
Graz, Austria, 8036
Medical University of Vienna and AKH Cardiology
Vienna, Austria, A-1090
Belarus
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, 223040
Belgium
Ulb Erasme, Cardiology
Brussels, Belgium, 1070
University Hospital Gasthuisberg - Pneumologie
Leuven, Belgium, 3000
Canada, Alberta
University of Alberta Hospital-Children's Centre WCM 2E4.33
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 of Ottawa Heart Institute
Ottawa, Ontario, Canada, K1Y 4W7
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 de Quebec
Quebec City, Quebec, Canada, G1V 4G5
Chile
Instituto Nacional del Torax Teaching Dept
Santiago, Chile, 7500691
Clinica Tabancura- Cardiology Unit
Santiago, Chile, 7650018
Pontificia Universidad Catolica de Chile-Departmento De Enfermedades Cardiovasculares
Santiago, Chile, 8330074
China
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
Shanghai Pulmonary Hospital, Department of Pulmonary Circulation
Shanghai, China, 200433
Renji Hospital, Cardiology Department
Shanghai, China, 200127
Colombia
Hospital Militar Central-Pneumology
Bogota, Colombia
Fundacion Cardio Infantil
Bogota, Colombia
Fundacion Clinica Shaio
Bogota, Colombia
Czech Republic
1. Lékařská fakulta a Všeobecná fakultní nemocnice v Praze, II. Interní klinika kardiologie a angiologie
Praha 2, Czech Republic, 128 08
Denmark
Aarhus University Hospital , Cardiology
Arhus, Denmark, 8200
Rigshospitalet, Hjertemedicinsk klinik - Cardiology
Copenhagen, Denmark, 2100
Germany
DRK Kliniken Köpenick
Berlin, Germany, 12559
Universitätsklinikum Carl Gustav Carus, Medizinische Klinik1-Pneumologie/MK1-A13
Dresden, Germany, 01307
"Justus-Liebig-Universität Gießen Zentrum für Innere Medizin Medizinische Klinik II"
Giessen, Germany, 35392
Universität Greifswald / Klinik für Innere Medizin B
Greifswald, Germany, 17487
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
Klinik Löwenstein gGmbH, Medizinische Klinik 1, Pneumologie - Kardiologie
Löwenstein, Germany, 74245
Universitätsklinkum Regensburg / Innere Medizin II
Regensburg, Germany, 93053
Greece
Onasseio Cardiosurgical Hospital
Athens, Greece, 176 74
Hungary
Semmelweis Egyetem, Pulmonológiai Klinika
Budapest, Hungary, 1125
"Gottsegen György Országos Kardiológiai Intézet, Felnőtt kardiológiai osztály"
Budapest, Hungary, 1096
Egészségügyi Járóbeteg Központ Kardiológiai Intézete - Debrecen
Debrecen, Hungary, 4032
"Pécsi Tudományegyetem Klinikai Központ,
Pécs, Hungary, 7624
"Szegedi Tudományegyetem ÁOK Szent-Györgyi Albert Klinikai Központ, II. sz. Belgyógyászati klinika és Kardiológiai központ"
Szeged, Hungary, 6720
India
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
Indraprastha Apollo Hospital
New Delhi, India, 110076
Ireland
Mater Miscordiae University Hospital
Dublin, Ireland, Dublin 7
Israel
Carmel Medical Center, Pulmonary Unit
Haifa, Israel, 34362
Pulmonology Institute, Hadassah University Hospital at Ein Karem
Jerusalem, Israel, 91120
Rabin Medical Centre - Pulmonology
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
Italy
Policlinico S. Orsola-Malpighi - Dipartimento Cardio-Toraco-Vascolare
Bologna, Italy, 40138
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, 80131
ISMETT - Istituto Mediterraneo Trapianti e Terapie ad Alta Specializzazione - Dipartimento di Medicina - Divisione di Pneumologia
Palermo, Italy, 90127
Malaysia
Institut Jantung Negara (National Heart Institute)
Kuala Lumpur, Malaysia, 50400
Mexico
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
Peru
Hospital Nacional Edgardo Rebagliati / Unidad de Investigacion Cardiologia 2
Lima, Peru, 11
Instituto de Enfermedades Respiratorias Clinica San Gabriel
Lima, Peru, 32
Poland
"Uniwersyteckie Centrum Kliniczne II Klinika Kardiologii i Elektroterapii Serca"
Gdańsk, Poland, 80-952
"Instytut Kardiologii Collegium Medium UJ Krakowski Szpital Specjalistyczny im Jana Pawła II Klinika Chorób Serca i Naczyń"
Krakow, Poland, 31-202
"Instytut Gruźlicy i Chorób Płuc Klinika Chorób Wewnętrznych Klatki Piersiowej"
Warszawa, Poland, 01-138
"Wojewódzki Specjalistyczny Szpital im. dr Władysława Biegańskiego Oddział Kardiologiczny, II Katedra i Klinika Kardiologii UM"
Łódź, Poland, 91-347
Romania
"Institutul de Pneumologie "Marius Nasta", I. Clinica de Pneumoftiziologie"
Bucharest, Romania, 050159
"Spitalul Clinic de Pneumoftiziologie Iasi Sectia Clinica I de Pneumoftiziologie"
Iasi, Romania, 700115
Russian Federation
Municipal Medical Institution City Hospital #5
Barnaul, Russian Federation, 656045
Regional Clinical Hospital # 1/ Cardiology Department (2nd Therapy Department)
Ekaterinburg, Russian Federation, 620102
Kemerovo Cardiology Dispensary / Kemerovo Regional Hospital
Kemerovo, Russian Federation, 650044
The Institution of the Clinical Cardiology named after A. L. Myaskinov / Arterial Hypertension Department, Cardiology Research Complex Ministry of Healthcare RF
Moscow, Russian Federation, 121552
Scientific Research Institute of Pulmonology of Roszdrav
Moscow, Russian Federation, 105077
RAMS Institution "Scientific Institute of Rheumatology of RAMS"
Moscow, Russian Federation, 115552
Limited liability company, Consultative diagnostic centre Healthy Joints
Novosibirsk, Russian Federation, 630091
V. A. Almazov Institute of Cardiology, Russian Ministry of Healthcare and Social Development / Medical Treatment and Rehabilitation Complex
St Petersburg, Russian Federation, 194156
Tomsk Regional Clinical Hospital/ Pulmonology Unit
Tomsk, Russian Federation, 634063
Cardiology Scientific Research Institute of Tomsk Scientific Center of RAMs, Siberian Branch / Cardiovascular Surgery Department
Tomsk, Russian Federation, 634012
Serbia
"Klinički Centar Srbije, Klinika za pulmologiju"
Belgrade, Serbia, 11000
"Kliničko-bolnički centar Zemun, Kardiološko odeljenje"
Belgrade, Serbia, 11080
Singapore
National Heart Centre (NHC) Singapore
Singapore, Singapore, 168752
Slovakia
"Národný ústav srdcových a cievnych chorôb, a.s. - NÚSCH a.s. Oddelenie zlyhávania a transplantácie"
Bratislava 37, Slovakia, 833 48
Spain
Hosp Vall D'Hebron - Barcelona - Pneumology
Barcelona, Spain, 8035
Clinic-Barcelona
Barcelona, Spain, 8036
Hospital 12 de Octubre
Madrid, Spain
Sweden
Sahlgrenska Universitetssjukhuset, Kardiologi
Goteborg, Sweden, SE-413 45
Linköping University Hospital
Linkoping, Sweden, 58185
Norrlands universitetssjukhus, Hjärtcentrum
Umeå, Sweden, 901 85
Uppsala Akademiska Sjukhuset, Kardiologkliniken 50F
Uppsala, Sweden, 751 85
Switzerland
University Hospital Basel Division of Pneumology
Basel, Switzerland, 4031
Universitätsspital Bern, Clinic for Pneumology (Inselspital)
Bern, Switzerland, 3010
HUG Hôpitaux Universitaires de Genève; Pneumology, PAH
Genève 14, Switzerland, 1211
Taiwan
Kaohsiung Veterans General Hospital / Intensive Care Unit
Kaohsiung, Taiwan, 81362
National Taiwan University Hospital / Department of Surgery
Taipei, Taiwan, 100
Thailand
Srinagarind Hospital, Khon Kaen University, Division of Allergy-Immunology and Rheumatology, Department of Medicine
Khon Kaen Province, Thailand, 40002
Turkey
Çukurova Üniversitesi Tıp Fakültesi Kardiyoloji Anabilim Dalı
Adana, Turkey, 01330
Istanbul Üniversitesi Kardiyoloji Enstitisü
Istanbul, Turkey, 34096
Marmara Üniversitesi Tip Fakultesi Kardiyoloji Anabilim Dali
Istanbul, Turkey, 34899
Dokuz Eylül Üniversitesi Tıp Fakültesi Kardiyoloji Anabilim Dalı
İzmir, Turkey, 35210
Ukraine
"Dnipropetrovsk State Medical Academy / Regional Diagnostic Center, Department of electrophysiologic researches and anaesthesiologic aid, Chair of Hospital Therapy #2"
Dnepropetrovsk, Ukraine, 49060
City Clinical Hospital #13
Kharkiv, Ukraine, 61035
Lviv Regional Clinical Hospital, Cardiosurgery Department
Lviv, Ukraine, 79014
United Kingdom
Golden Jubilee - Pulm Vascular Unit
Glasgow, United Kingdom, G81 4HX
Sponsors and Collaborators
Actelion
Investigators
Study Director: Aline Frey Actelion
  More Information

No publications provided

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01112306     History of Changes
Other Study ID Numbers: AC-065A303
Study First Received: April 8, 2010
Last Updated: September 25, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board
Canada: Ethics Review Committee
Canada: Health Canada
Czech Republic: Ethics Committee
Denmark: Danish Medicines Agency
Denmark: Ethics Committee
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Institutional Ethical Committee
Ireland: Irish Medicines Board
Ireland: Research Ethics Committee
Israel: Ethics Commission
Israel: Ministry of Health
Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Singapore: Domain Specific Review Boards
Singapore: Health Sciences Authority
Slovakia: State Institute for Drug Control
Slovak Republic: Ethics Committee
Spain: Comité Ético de Investigación Clínica
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board
Taiwan: Department of Health
Taiwan: Institutional Review Board
Taiwan: National Bureau of Controlled Drugs
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
Australia: Department of Health and Ageing Therapeutic Goods Administration
Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council
Austria: Federal Office for Safety in Health Care
Belarus: Ministry of Health
China: Food and Drug Administration
Czech Republic: State Institute for Drug Control
Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Greece: Ethics Committee
Greece: National Organization of Medicines
Hungary: National Institute of Pharmacy
Hungary: Research Ethics Medical Committee
India: Drugs Controller General of India
India: Institutional Review Board
Italy: Ethics Committee
Italy: The Italian Medicines Agency
Malaysia: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Romania: Ethics Committee
Romania: National Medicines Agency
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Russia: Pharmacological Committee, Ministry of Health
Serbia: Ethics Committee
South Korea: Institutional Review Board
South Korea: Korea Food and Drug Administration (KFDA)
Switzerland: Swissmedic
Thailand: Ethical Committee
Thailand: Food and Drug Administration
Turkey: Ethics Committee
Turkey: Ministry of Health
Ukraine: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by Actelion:
Pulmonary Arterial Hypertension
PAH
Open-label

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014