Clinical Study to Assess the Long-term Safety and Tolerability of ACT 064992 in Patients With Symptomatic Pulmonary Arterial Hypertension
Study Purpose
The main objective of the AC 055 303/SERAPHIN OL study, which will follow the AC 055 302/SERAPHIN study, will be to assess the long-term safety and tolerability of ACT 064992 in patients with symptomatic PAH.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
|
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Interventional |
| Eligible Ages | 12 Years and Over |
| Gender | All |
Inclusion Criteria:
- - Signed informed consent prior to initiation of any study-mandated procedure.
- - Patients with pulmonary arterial hypertension and having completed the event-driven study, AC 055 302/SERAPHIN, or Patients who have experienced a clinical worsening of PAH in AC 055 302/SERAPHIN and for whom a written approval to roll over into this study has been obtained from the Sponsor.
- - Women of childbearing potential must have a negative pre-treatment serum pregnancy test and must use a reliable method of contraception during study treatment and for at least 28 days after study treatment termination.
Exclusion Criteria:
- - Any major violation of protocol AC 055 302/SERAPHIN.
- - Pregnancy or breast-feeding.
- - AST and/or ALT > 3 times the upper limit of the normal range.
- - 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 064992 or any of the excipients.
Trial Details
|
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT00667823 |
|
Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
Phase 3 |
|
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Actelion |
|
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
N/A |
| Principal Investigator Affiliation | N/A |
|
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Industry |
| Overall Status | Active, not recruiting |
| Countries | Argentina, Australia, Austria, Belarus, Belgium, Bulgaria, Canada, Chile, China, Colombia, Croatia, Finland, France, Germany, Hong Kong, Hungary, India, Israel, Italy, Malaysia, Mexico, Netherlands, Peru, Poland, Romania, Russian Federation, Serbia, Singapore, Slovakia, South Africa, Sweden, Taiwan, Thailand, Ukraine, United Kingdom, United States |
|
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Pulmonary Arterial Hypertension |
Arms
Experimental: ACT-064992
ACT-064992
Interventions
Drug: - Macitentan
Tablet, oral administration, 10 mg dose once daily
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Address
University of Alabama at Birmingham
Birmingham, Alabama, 35249-0001
Status
Address
Arizona Pulmonary Specialists
Phoenix, Arizona, 85012
Status
Address
University of California, San Diego
La Jolla, California, 92037
Status
Address
GLVA Healthcare Center
Los Angeles, California, 90073
Status
Address
Santa Barbara Cottage Hospital
Santa Barbara, California, 93105
Status
Address
Liu Center for Pulmonary Hypertension
Torrance, California, 90502-2006
Status
Address
University of Colorado CARDIAC AND VASCULAR CENTER
Aurora, Colorado, 80045-2548
Status
Address
University of Florida - Division of Pulmonology
Gainesville, Florida, 32610
Status
Address
Mayo Clinic, Jacksonville
Jacksonville, Florida, 32259
Status
Address
Emory University Hospital - McKelvey Center for Lung Transplantation & Pulmonary Vascular Disease
Atlanta, Georgia, 30322
Status
Address
Pulmonary & Critical Care of Atlanta
Atlanta, Georgia, 30342-1713
Status
Address
Atlanta Institute for Medical Research
Decatur, Georgia, 30030
Status
Address
University of Chicago
Chicago, Illinois, 60637-1432
Status
Address
University of Iowa, Pulmonary Hypertension Program
Iowa City, Iowa, 52242-1081
Status
Address
University of Kansas Medical Center
Kansas City, Kansas, 66160
Status
Address
Kentuckiana Pulmonary Associate, PLLC
Louisville, Kentucky, 40202
Status
Address
Louisiana State University Health Sciences Center
New Orleans, Louisiana, 70112-1393
Status
Address
Maine Medical Center
Portland, Maine, 04102-3134
Status
Address
University of Maryland School of Medicine; Division of Cardiology
Baltimore, Maryland, 21201-1544
Status
Address
Pulmonary/Critical Care Division/Tufts New England Medical Center
Boston, Massachusetts, 02111-1552
Status
Address
Massachusetts General Hospital
Boston, Massachusetts, 02114
Status
Address
Boston University School of Medicine
Boston, Massachusetts, 02118
Status
Address
University of Michigan
Ann Arbor, Michigan, 48109
Status
Address
Harper Univ. Hospital/ Wayne State University
Detroit, Michigan, 48201
Status
Address
Washington University School of Medicine
Saint Louis, Missouri, 63110-1010
Status
Address
University of Nebraska Medical Center
Omaha, Nebraska, 68198
Status
Address
University of NJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08903-0010
Status
Address
Columbia University Medical Center - Pediatric Cardiology
New York, New York, 10032
Status
Address
Duke University Medical Center
Durham, North Carolina, 27710-0001
Status
Address
University of Cincinnati Ohio Heart Health Center
Cincinnati, Ohio, 45219-2906
Status
Address
Ohio State University, Div. of Pul. & Critical Care
Columbus, Ohio, 43210
Status
Address
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Status
Address
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
Status
Address
University of Texas Medical Center - St. Paul University
Dallas, Texas, 75390-8550
Status
Address
Baylor College of Medicine and the Methodist Hospital,
Houston, Texas, 77030
Status
Address
University of Texas Houston Health Center
Houston, Texas, 77030
Status
Address
Intermountain Med Ctr- Pulm Dept Heart and Lung Ctr
Murray, Utah, 84157-5701
Status
Address
Sentara Hospitals T/A Sentara Cardiovascular Research Intitute
Norfolk, Virginia, 23507-1904
Status
Address
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53125
International Sites
Status
Address
Sanatorio Otamendi y Miroli S.A.
Buenos Aires, Ciudad Autonoma, C1121ABL
Status
Address
Hospital Britanico
Buenos Aires, Ciudad Autonoma, C1280AEB
Status
Address
Sanatorio MITRE
Buenos Aires, , C1039AAO
Status
Address
Fundacion Favaloro
Buenos Aires, , C1093AAS
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Address
Htal Italiano Cordoba
Cordoba, , X5004BAL
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Address
Htla privado de Cordoba
Cordoba, , x5016keh
Status
Address
Instituto Cardiologia Corrientes
Corrientes, , W3400AMZ
Status
Address
Hospital Italiano - Garibaldi de Rosario
Santa Fe, , S2001ODA
Status
Address
St. Vincent's Hospital
Darlinghurst, , 2010
Status
Address
The Alfred Hospital
Melbourne, , 3004
Status
Address
Royal Brisbane Hospital
Sunshine Coast, , 4558
Status
Address
Medical University of Vienna/ Department of Internal Medicine II, Division of Cardiology
Vienna, , 1090
Status
Address
Republican reserach - Pratical Centre of Cardiology
Minsk, , 220036
Status
Address
Minsk Regional Clinical Hospital
Minsk, , 223041
Status
Address
Vitebsk Regional Clinical Hospital
Vitebsk, , 210037
Status
Address
University Hospital Gasthuisberg
Leuven, , 3000
Status
Address
Mhat Nat Card Hosp - Pediatric Clinic
Sofia, BG, 1309
Status
Address
Peter Lougheed Centre
Calgary, Alberta, T1Y 6J4
Status
Address
London Health Sciences Centre
London, Ontario, N6C 2R5
Status
Address
Toronto General Hospital
Toronto, Ontario, M5G 2N2
Status
Address
L'Hopital Laval
Sainte-Foy, Quebec, G1V 4G5
Status
Address
Hospital del Torax
Santiago de Chile, , 7500691
Status
Address
Pontificia Universidad Catolica de Chile
Santiago de Chile, , 833034
Status
Address
Hospital San Juan de Dios
Santiago, , 8350488
Status
Address
Beijing Anzhen Hospital of the Capital University of Medical Sciences, Cardiology Department
Beijing, , 100029
Status
Address
Peking Union Medical College Hospital, Rheumatology Department
Beijing, , 100032
Status
Address
Guangdong General Hospital, Cardiology Department
Guangzhou, , 510080
Status
Address
Jiangsu Province Hospital - Pneumology Department
Nanjing, , 210029
Status
Address
Renji Hospital, Rheumatology Department
Shanghai, , 200001
Status
Address
Zhongshan Hospital Fudan University, Cardiology Department
Shanghai, , 200032
Status
Address
Renji Hospital, Cardiology Department
Shanghai, , 200127
Status
Address
Shanghai Pulmonary Hospital Department of Pulmonary Circulation
Shanghai, , 200433
Status
Address
Fundacion Cardiovascular de Colombia
Floridablanca, Santander,
Status
Address
Fundacion Clinica Shaio
Bogota, ,
Status
Address
Clinical Hospital Center
Rijeka, , 51 000
Status
Address
Helsinki University Central Hospital
Helsinki, , 00290
Status
Address
Hosp Bicetre - Dept Pulmo & Resp Intensive Care
Le Kremlin-Bicêtre cedex, , 94275
Status
Address
Hopital Arnaud de Villeneuve Service des Maladies Respiratoires
Montpellier, , 34295
Status
Address
Hopital Haut-Leveque-Maison du Haut-Leveque
Pessac, , 33604
Status
Address
Unfallkrankenhaus Berlin, Klinik für Innere Medizin
Berlin, , 12683
Status
Address
Medizinische Klinik und Poliklinik I Universitätsklinikum Carl Gustav Carus
Dresden, , 01307
Status
Address
Universitätsklinikum Essen, Klinik für Kardiologie , Zentrum für Innere Medizin
Essen, , 45122
Status
Address
Universitätsklinikums Gießen und Marburg GmbH / Medizinische Klinik und Poliklinik II, Innere Med. / Pneumologie
Giessen, , 35392
Status
Address
Universität Greifswald / Klinik für Innere Medizin B,
Greifswald, , 17475
Status
Address
Universitätsklinikum Hamburg-Eppendorf / Onkologie, Hämatologie und Knochenmarktransplantation mit Sektion Pneumologie
Hamburg, , 20246
Status
Address
Medizinische Hochschule Hannover / Klinik für Pneumologie
Hannover, , 30625
Status
Address
Thoraxklinik am Universitätsklinikum Heidelberg
Heidelberg, , 69126
Status
Address
Universitätskliniken des Saarlandes / Medizinische Klinik und Poliklinik, Innere Medizin V
Homburg/Saar, , 66421
Status
Address
Universität zu Köln, Medizinische Klinik III, Abteilung Kardiologie
Koln, , 50924
Status
Address
Universtätsklinik Leipzig
Leipzig, , 04103
Status
Address
Medizinische Klinik und Poliklinik I der Ludwig-Maximilians-Universität München / Klinikum Großhadern, Schwerpunkt Pneumologie
Munich, , 81377
Status
Address
Universitatsklinikum Regensburg/Innere Medizin II
Regensburg, , 93053
Status
Address
Prince of Wales Hospital/ Division of Rheumatology, Department of Medicine & Therapeutics
Hong Kong, ,
Status
Address
Gottsegen György Országos Kardiológiai Intézet (Hungarian Institute of Cardiology)
Budapest, , 1096
Status
Address
"Semmelweis Egyetem, Pulmonológiai Klinika"
Budapest, , 1125
Status
Address
University of Pecs, Medical School/Heart Institute and 1st Department of Internal Medicine
Pecs, , 7624
Status
Address
University of Szeged Albert Szent-Gyorgyi Medical & Pharmaceutical Center
Szeged, , 6720
Status
Address
Life Care Institute of Medical Science & Research, Ahmedabad
Ahmedabad, , 382428
Status
Address
Care Hospital
Hyderabad, , 500001
Status
Address
Seth GS Medical College & King Edward VII Memorial (KEM) Hospital / Department Of Cardiology
Mumbai, , 400012
Status
Address
P D Hinduja National Hospital and Medical Research Centre/ Pulmunory Medicine
Mumbai, , 400016
Status
Address
G B Pant Hospital & Maulana Azad Medical College
New Delhi, , 110 002
Status
Address
Deenanath Mangeshkar Hospital and Research Centre
Pune, , 411 004
Status
Address
Rambam Health Care Campus / Division of Medicine, Institute of Pulmonology
Haifa, , 31096
Status
Address
Lady Davis Carmel Medical Center / Department of Cardiovascular Medicine, Pulmonary Division
Haifa, , 34362
Status
Address
Rabin Medical Center - Belinson campus - Pulmonary Institute
Petach - Tikvah, , 49100
Status
Address
Pulmonary Institute, Kaplan Medical Center
Rehovot, , 76100
Status
Address
The pulmonary institute Sheba Medical centre
Tel Hashomer, , 52621
Status
Address
Sourasky Medical Center - Division of Pulmonary Medicine and Allergy
Tel-Aviv, , 64239
Status
Address
IRCCS Policlinico San Matteo Policlinico / Dipartimento di Cardiologia
Pavia, , 207100
Status
Address
Policlinico Umberto I, Cardiologia
Roma, , 00161
Status
Address
Institut Jantung Negara (National Heart Institute)
Kuala Lumpur, , 50400
Status
Address
Instituto Nacional de Cardiología (INC) Ignacio Chávez
Mexico City, , 14080
Status
Address
Unidad de Investigación Clinica en Medicina
Monterrey, , 64718
Status
Address
VU Medisch Centrum, Dept. Pulmonology 4A 48
Amsterdam, , 1081 HV
Status
Address
St. Antonius ziekenhuis
Nieuwegein, , 3435 CM
Status
Address
Hospital Alberto Sabogal Sologuren - EsSALUD
Callao, , Callao 02
Status
Address
Clinica Medica Cayetano Heredia
Lima, , 31
Status
Address
Instituto de Enfermedades Respiratorias
Lima, , 32
Status
Address
Klinika Chorob Serca i Naczyn Instytut Kardiologii Collegium Medicum UJ
Krakow, , 31-202
Status
Address
Cardiology Otwock Priv
Otwock, , 05-400
Status
Address
III Katedra i Oddział Kliniczny Kardiologii Slaskiego Uniwersytetu Medycznego
Zabrze, , 41-800
Status
Address
Institutul de Pneumologie "Marius Nasta" / I. Clinica de Pneumoftiziologie
Bucharest, , 050159
Status
Address
Institutul de boli cardiovasculare / Clinica de Cardiologie
Bucuresti, , 022328
Status
Address
Sverdlovsk Regional Clinical Hospital # 1/ Cardiology Department (2nd Therapy Department)
Ekaterinburg, , 620102
Status
Address
Municipal Health Care Institution Kemerovo Cardiology Dispensary
Kemerovo, , 650002
Status
Address
Federal State Institution "State Scientific Research Centre of Preventive Medicine" of Rosmedtechnology
Moscow, , 101990
Status
Address
Federal State Institution "Scientific Research Institute of Pulmonology of Roszdrav"
Moscow, , 105077
Status
Address
State Health Care Institution of Moscow "City Clinical Hospital #1 named after N. I. Pirogov"
Moscow, , 117049
Status
Address
Federal State Institution "Russian Cardiology Scientific and Production Complex of Rosmedtechnology"
Moscow, , 121552
Status
Address
State Educational Institution "St Petersburg Medical Academy of Postgraduate Education" of Federal Agency of Public Health and Social Development
St Petersburg, , 193015
Status
Address
State Educational Institution of High Professional Education "St Petersburg State Medical
St Petersburg, , 197 022
Status
Address
Federal State Institution "Federal Center of Heart, Blood and Endocrinology named after V.A. Almazov" of Rosmedtechnology
St. Petersburg, , 197341
Status
Address
State Institution "Scientific Research Institute of Cardiology" of Tomsk Scientific Center of RAMS, Siberian branch
Tomsk, , 634012
Status
Address
Tomsk Regional Clinical Hospital / Pulmonology Unit
Tomsk, , 634063
Status
Address
Municipal Health Care Institution "Clinical Hospital of Emergency Care named after N.V. Soloviov"
Yaroslavl, , 150 003
Status
Address
University Children's Hospital (UNIVERZITETSKA DECJA KLINKIKA)
Belgrade, , 11000
Status
Address
University Clinical Center of Serbia/ Institute for Lung Diseases and Tuberculosis
Belgrade, , 11000
Status
Address
Zemun Clinical Hospital (Klinicko-bolnicki centar Zemun) / Department of Cardiology
Belgrade, , 11080
Status
Address
National University Hospital/ The Heart Institute
Singapore, , 119228
Status
Address
National Heart Centre (Nhc) Singapore
Singapore, , 169609
Status
Address
National Institute of Cardiovascular Diseases (Slovenska zdravotnicka univerzita) / Faculty of Medical Specialty Studies (Fakulta zdravotnickych speci
Bratislava, , 833 48
Status
Address
Slovak Medical University (Slovenská zdravotnícka univerzita) / Faculty of Medical Speciality Studies (Fakulta zdravotníckych špecializačných štúdií)
Bratislava, , 833 48
Status
Address
Tread Research
Cape Town, , 7505
Status
Address
Chris Hani Baragwanath Hospital, Department of Cardiology
Johannesburg, , 2013
Status
Address
Netcare Milpark Hospital,Center for Chest Disease
Johannesburg, , 2193
Status
Address
Block 4, Vergelegen Medi-Clinic
Somerset West, , 7130
Status
Address
University Hospital of Lund, Dept. of Cardiology
Lund, , 221 85
Status
Address
Uppsala University Hospital, Cardiology
Uppsala, , 751 85
Status
Address
Taichung Veterans General Hospital
Taichung, , 40705
Status
Address
National Taiwan University Hospital/ Thoracic Surgical Division, Surgical Department
Taipei, , 100
Status
Address
Ramathibodi Hospital, Mahidol University, Cardiology Unit, Department of Medicine,
Bangkok, , 10400
Status
Address
Siriraj Hospital, Mahidol University
Bangkok, , 10700
Status
Address
Maharaj Nakorn Chiang Mai Hospital, Division of Rheumatology
Chiang Mai, , 50200
Status
Address
Srinagarind Hospital/Division of Rheumatology, Department of Medicine, Faculty of Medicine, Khon Kaen University
Khon Kaen, , 40002
Status
Address
Dnipropetrovsk State Medical Academy / Regional Diagnostic Center, Department of electrophysiologic researches and anaesthesiologic aid
Dnepropetrovsk, , 49060
Status
Address
Danylo Galytskyi Lviv State Medical University
Lviv, , 79010
Status
Address
Odessa State Medical University, Military-medical Clinical Center of the South region
Odessa, , 65044
Status
Address
Royal Free Hospital
London, , NW3 2QG
