ACT-293987 in Pulmonary Arterial Hypertension
This study is enrolling participants by invitation only.
Sponsor:
Actelion
Information provided by (Responsible Party):
Actelion
ClinicalTrials.gov Identifier:
NCT01112306
First received: April 8, 2010
Last updated: April 25, 2013
Last verified: April 2013
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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 ACT-293987 in Patients With Pulmonary Arterial Hypertension |
Resource links provided by NLM:
Genetics Home Reference related topics:
pulmonary arterial hypertension
MedlinePlus related topics:
High Blood Pressure
U.S. FDA Resources
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 2015 |
| Estimated Primary Completion Date: | December 2014 (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 have completed the double-blind study AC-065A302 as scheduled per protocol (i.e., treated until unblinding of the study), or who have experienced a clinical worsening of PAH (adjudicated by the CEC) during study AC-065A302.
- Signed informed consent
Exclusion Criteria:
- Any major violation of protocol AC-065A302.
- Females 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.
- Known hypersensitivity to ACT-293987 or any of the excipients.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01112306
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| 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 | |
| Massachusetts General Hospital-Pulmonary Critical Care Unit | |
| Boston, Massachusetts, United States, 02114 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| Medical College of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| Argentina | |
| Centro de Investigacion y Prevencion Cardiovascular (CIPREC) | |
| Buenos Aires, Argentina, C1119ACN | |
| Sanatorio Otamendi y Miroli S.A. | |
| Buenos Aires, Argentina, C1121ABL | |
| Hospital Britanico-Pneumology | |
| Buenos Aires, Argentina, C1280AEB | |
| Sanatorio San Jose | |
| Buenos Aires, Argentina, C1425DUH | |
| 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 | |
| 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 | |
| Cardiovascular Institute & Fuwai Hospital-Pulmonary Vascular Center | |
| Beijing, China, 100037 | |
| Beijing Shijitan Hospital | |
| Beijing, China, 100038 | |
| 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 | |
| Hospital Militar Central-Pneumology | |
| Bogota, Colombia | |
| Fundacion Cardio Infantil | |
| 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 | |
| University Hospital of Ahepa | |
| Thessaloniki, Greece, 54636 | |
| 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 | |
| Frontier Lifeline - Dr. K.M. Cherian Heart Foundation | |
| Chennai, India, 600101 | |
| Apollo Hospital | |
| Chennai, India, 600006 | |
| 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 | |
| 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/ Cardiology Department (2nd Therapy Department) | |
| Ekaterinburg, Russian Federation, 620102 | |
| Kemerovo Cardiology Dispensary / Kemerovo Regional Hospital | |
| Kemerovo, Russian Federation, 650044 | |
| Scientific Research Institute of Pulmonology of Roszdrav | |
| Moscow, Russian Federation, 105077 | |
| 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 | |
| RAMS Institution "Scientific Institute of Rheumatology of RAMS" | |
| Moscow, Russian Federation, 115552 | |
| State Institution "Scientific Research Institute of clinical and experimental Lymphology of RAMS, Siberian branch" | |
| Novosibirsk, Russian Federation, 630117 | |
| V. A. Almazov Institute of Cardiology, Russian Ministry of Healthcare and Social Development / Medical Treatment and Rehabilitation Complex | |
| St Petersburg, Russian Federation, 194156 | |
| 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 | |
| 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 | |
| Východoslovenský ústav srdcových a cievnych chorôb, a.s., Kardiologické oddelenie | |
| Košice, Slovakia, 040 11 | |
| Spain | |
| Clinic-Barcelona | |
| Barcelona, Spain, 8036 | |
| Hosp Vall D'Hebron - Barcelona - Pneumology | |
| Barcelona, Spain, 8035 | |
| Hospital 12 de Octubre | |
| Madrid, Spain | |
| Sweden | |
| Sahlgrenska Universitetssjukhuset, Kardiologi | |
| Goteborg, Sweden, SE-413 45 | |
| 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 | |
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: | April 25, 2013 |
| 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, Pulmonary Hypertension Lung Diseases |
Respiratory Tract Diseases Vascular Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 22, 2013