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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01106014
First received: April 2, 2010
Last updated: September 25, 2014
Last verified: September 2014
  Purpose

The AC-065A302 GRIPHON study is an event-driven Phase 3 study to demonstrate the effect of ACT-293987 on time to first morbidity or mortality event in patients with pulmonary arterial hypertension.


Condition Intervention Phase
Pulmonary Arterial Hypertension
Drug: Selexipag (ACT-293987)
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • Time to first adjudicated morbidity or mortality event (up to 7 days after last study-drug intake) [ Time Frame: Baseline (day 1) to over a period of up to 4.3 years ] [ Designated as safety issue: Yes ]

    defined as

    • Death or
    • Hospitalization for worsening of PAH or
    • Worsening of PAH resulting in need for lung transplantation or balloon atrial septostomy or
    • Initiation of parenteral prostanoid therapy or chronic oxygen therapy or
    • Disease progression


Secondary Outcome Measures:
  • Evaluate the effect of ACT-293987 on exercise capacity (6-minute walk distance & Borg dyspnea index) & other secondary & exploratory efficacy endpoints in patients with PAH [ Time Frame: Baseline (day 1) to over a period of up to 4.3 years ] [ Designated as safety issue: Yes ]

Enrollment: 1156
Study Start Date: December 2009
Estimated Study Completion Date: October 2014
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Selexipag (ACT-293987), twice daily
Drug: Selexipag (ACT-293987)
tablets, twice daily
Other Name: Selexipag (ACT-293987)
Placebo Comparator: 2
Matching placebo, twice daily
Drug: Placebo
tablet, matching placebo, twice daily
Other Name: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  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: NCT01106014

  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, 92037
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
Georgia Health Sciences University
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
Massachusetts General Hospital - Pulmonary Critical Care Unit
Boston, Massachusetts, United States, 02114
Massachusetts General Hospital-Pulmonary Critical Care Unit
Boston, Massachusetts, United States, 02114
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 Isreal Medical Center-Department of Pulmonary Medicine
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
University of Cincinnati
Cincinnati, Ohio, United States, 45267
The Lindner Clinical Trial Center
Cincinnati, Ohio, United States, 45219-2906
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
The Ohio State University Medical Center
Colombus, 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
Baylor College of Medicine
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
St. Luke's Medical Center
Milwaukee, Wisconsin, United States, 53215
Froedtert Hospital - Medical College of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Argentina
Centro de Investigacion y Prevencion Cardiovascular (CIPREC)
Buenos Aires, Argentina, C1119ACN
Sanatorio San Jose
Buenos Aires, Argentina, C1425DUH
Hospital Britanico-Pneumology
Buenos Aires, Argentina, C1280AEB
Sanatorio Otamendi y Miroli S.A.
Buenos Aires, Argentina, C1121ABL
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
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/- Cardiology
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
St Vincent's Hospital
Fitzroy, Victoria, Australia, 3065
Australia
Royal Hobart Hospital, Centre for Clinical Research
Hobart, Australia, TAS 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
Minsk City Hospital No. 9
Minsk, Belarus, 220116
The Republican Scientific-Practical Center "Cardiology"
Minsk, Belarus, 220036
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
Edmonton, Alberta, Canada, T6G2C8
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
Pontificia Universidad Catolica de Chile-Departmento De Enfermedades Cardiovasculares
Santiago, Chile, 8330074
Clinica Tabancura- Cardiology Unit
Santiago, Chile, 7650018
Instituto Nacional del Torax Teaching Dept
Santiago, Chile, 7500691
China
Beijing Shijitan Hospital
Beijing, China, 100038
Cardiovascular Institute & Fuwai Hospital-Pulmonary Vascular Center
Beijing, China, 100037
Peking Union Medical College Hospital, Rheumatology Department
Beijing, China, 100032
Guangdong General Hospital, Cardiology Department
Guangzhou, China, 510080
Shanghai Pulmonary Hospital, Department of Pulmonary Circulation
Shanghai, China, 200433
Renji Hospital, Cardiology Department
Shanghai, China, 200127
Renji Hospital, Rheumatology Department
Shanghai, China, 200001
Colombia
Fundacion Clinica Shaio
Bogota, Colombia
Fundacion Cardio Infantil
Bogota, Colombia
Czech Republic
Gen Faculty Hosp Prague Cardiology Clin
Praha 2, Czech Republic, 128 08
Denmark
Aarhus University Hospital , Cardiology
Arhus, Denmark, 8200
Rigshospitalet, Hjertemedicinsk klinik - Cardiology
Copenhagen, Denmark, 2100
France
Hosp Pradel Lyon - Dpt Pneumology
Bron cedex, France, 69677
Hosp Cote de Nacre - Dpt Pneumology
Caen Cedex, France, 14033
Hosp A. Beclere - Dept Pulmo & Resp Intensive Care
Clamart, France, 92140
Hosp Huriez - Dpt Internal Medecine
Lille Cedex, France, 59037
Hosp Civil - Dpt Pneumology
Strasbourg, France, 67091
Hosp Larrey - Dpt Pneumology
Toulouse Cedex 9, France, 31059
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 Hospitals, Chennai
Chennai, India, 600006
Frontier Lifeline Hospitals, Dr KM Cherian Heart Foundation, Chennai
Chennai, India, 600101
CARE Hospitals Nampally, Cardiology Dep. Hyderabad
Hyderabad, India, 500001
Apollo Indraprastha Hospitals
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 - Pulmonary Institute
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
Korea, Republic of
Gil Medical Centre
Incheon, Korea, Republic of, 405-760
Yonsei University Health System Dept of Cardiology
Seoul, Korea, Republic of, 120-752
Seoul Nathional University Hospital
Seoul, Korea, Republic of, 110-744
Samsung Medical Center, Division of Cardiology
Seoul, Korea, Republic of, 135-710
"The Catholic University of Korea, Seoul St. Mary's Hospital Department of Cardiology"
Seoul, Korea, Republic of, 137-701
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
Netherlands
VU Medisch Centrum / Afdeling longziekten, secretariaat 4A 48
Amsterdam, Netherlands, 1081 HV
Academisch Ziekenhuis Maastricht / Department of Pulmonary Diseases
Maastricht, Netherlands, 6229 HX
St. Antonius Ziekenhuis afdeling Longziekten
Nieuwegein, Netherlands, 3430 EM
Erasmus Medisch Centrum Rotterdam afdeling longziekten
Rotterdam, Netherlands, 3015 GD
Peru
Instituto de Enfermedades Respiratorias Clinica San Gabriel
Lima, Peru, 32
Hospital Nacional Edgardo Rebagliati / Unidad de Investigacion Cardiologia 2
Lima, Peru, 11
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
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
Moscow, Russian Federation, 121552
Scientific Research Institute of Pulmonology of the Federal Medical and Biological Agency of Russia
Moscow, Russian Federation, 105077
State Institution, "Institute fo 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.
Bratislava, Slovakia, 833 48
Spain
Clinic-Barcelona
Barcelona, Spain, 8036
Hosp Vall D'Hebron - Barcelona - Pneumology
Barcelona, Spain, 8035
Hospital 12 Octubre
Madrid, Spain, 28041
Sweden
Sahlgrenska Universitetssjukhuset, Kardiologi
Goteborg, Sweden, SE-413 45
Linköping University Hospital, Cardiology
Linköping, Sweden, 58185
Umeå University Hospital, Cardiology (Umeå)
Umea, Sweden, 90185
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
Kantonsspital St. Gallen Klinik für Pneumologie
St. Gallen, Switzerland, 9007
Taiwan
Kaohsiung Veterans General Hospital (KVGH)
Kaohsiung, Taiwan
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, Municipal Institution ""Dnipropetrovsk Regional Clinic Diagnostic Center""
Dnipropetrovsk, Ukraine, 49060
Health Care Municipal Institution, City Clinical Hospital #13
Kharkiv, Ukraine, 61124
Public Institution "F.H. Yanovski Phthisiology and Pulmonology National Institute Under Ukrainian Academy of Medical Sciences"
Kyiv, Ukraine, 03680
Lviv Regional Clinical Hospital
Lviv, Ukraine, 79010
United Kingdom
Golden Jubilee - Pulm Vascular Unit
Glasgow, United Kingdom, G81 4HX
Hammersmith
London, United Kingdom, W12 0HS
Royal Free & Ucms Rheumatology Unit
London, United Kingdom, NW3 2QG
Sponsors and Collaborators
Actelion
Investigators
Study Director: Aline Frey Actelion
  More Information

No publications provided

Responsible Party: Actelion
ClinicalTrials.gov Identifier: NCT01106014     History of Changes
Other Study ID Numbers: AC-065A302
Study First Received: April 2, 2010
Last Updated: September 25, 2014
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
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
Austria: Ethikkommission
Belarus: Ministry of Health
Belgium: Federal Agency for Medicinal Products and Health Products
Belgium: Institutional Review Board
Canada: Ethics Review Committee
Canada: Health Canada
Chile: Comité de Ética Científico
China: Food and Drug Administration
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: Ethics Committee
Czech Republic: State Institute for Drug Control
Denmark: Danish Medicines Agency
Denmark: Ethics Committee
France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Institutional Ethical Committee
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
Ireland: Irish Medicines Board
Ireland: Research Ethics Committee
Israel: Ethics Commission
Israel: Ministry of Health
Italy: Ethics Committee
Italy: The Italian Medicines Agency
Malaysia: Ministry of Health
Mexico: Federal Commission for Protection Against Health Risks
Netherlands: Medical Ethics Review Committee (METC)
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Peru: Instituto Nacional de Salud
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Poland: Ethics Committee
Romania: Ethics Committee
Romania: National Medicines Agency
Russia: Ethics Committee
Russia: Ministry of Health of the Russian Federation
Russia: FSI Scientific Center of Expertise of Medical Application
Russia: Pharmacological Committee, Ministry of Health
Serbia: Ethics Committee
Serbia and Montenegro: Agency for Drugs and Medicinal Devices
Singapore: Domain Specific Review Boards
Singapore: Health Sciences Authority
Slovak Republic: Ethics Committee
Slovakia: State Institute for Drug Control
South Korea: Institutional Review Board
South Korea: Korea Food and Drug Administration (KFDA)
Spain: Comité Ético de Investigación Clínica
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Sweden: Regional Ethical Review Board
Switzerland: Swissmedic
Switzerland: Ethikkommission
Taiwan: Department of Health
Taiwan: Institutional Review Board
Thailand: Ethical Committee
Thailand: Food and Drug Administration
Turkey: Ethics Committee
Turkey: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United Kingdom: Research Ethics Committee
Ukraine: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health

Keywords provided by Actelion:
pulmonary arterial hypertension
PAH

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

ClinicalTrials.gov processed this record on October 19, 2014