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| Sponsor: | Actelion |
|---|---|
| Information provided by: | Actelion |
| ClinicalTrials.gov Identifier: | NCT00631475 |
Purpose
This Open-label extension study in patients with Idiopathic Pulmonary Fibrosis who completed protocol AC-052-321 / BUILD 3 will asses the long term safety and tolerability of bosentan in patients with idiopathic pulmonary fibrosis (IPF).
| Condition | Intervention | Phase |
|---|---|---|
|
Idiopathic Pulmonary Fibrosis |
Drug: Bosentan |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety Study |
| Official Title: | Open-Label Extension Study in Patients With Idiopathic Pulmonary Fibrosis Who Completed Protocol AC-052-321 |
| Estimated Enrollment: | 600 |
| Study Start Date: | March 2008 |
| Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
For patients who were administered bosentan during BUILD 3: Same dose will continue For patients who were administered placebo during BUILD 3: Initial dose: 62.5 mg for 4 weeks Maintenance dose: 125 mg |
Drug: Bosentan
For patients who were administered Bosentan during BUILD 3: continue on same dose For patients who were administered placebo during BUILD 3: Oral Bosentan 62.5 mg for 4 weeks; maintenance dose: 125 mg ( 62.5 if patient weighs < 90 lbs.) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Patients should have completed all the assessments from the BUILD 3 EOS visit.
Exclusion Criteria:
Contacts and Locations
Hide Study Locations| United States, Alabama | |
| UAB Division of Pulmonary | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arizona | |
| Mayo Clinic | |
| Scottsdale, Arizona, United States, 85259 | |
| Pulmonary Associates | |
| Phoenix, Arizona, United States, 85006 | |
| United States, California | |
| UCLA- Division of Pulmonary & Critcal Care | |
| Los Angeles, California, United States, 90095 | |
| Pulmoary and Critical Care Medicine-Stanford University Medical Center | |
| Stanford, California, United States, 94305 | |
| UCSD Medical Center | |
| San Diego, California, United States, 92103 | |
| USCF-Interstitial Lung Disease Center | |
| San Francisco, California, United States, 94143 | |
| UC Davis University of California | |
| Sacramento, California, United States, 95817 | |
| United States, Colorado | |
| National Jewish Medical & Research Center | |
| Denver, Colorado, United States, 80206 | |
| United States, Connecticut | |
| Yale University School of Medicine | |
| New Haven, Connecticut, United States, 06520 | |
| United States, Florida | |
| PAB Clinical Research | |
| Brandon, Florida, United States, 33511 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States | |
| United States, Kansas | |
| Wichita Clinic, P.A. | |
| Wichita, Kansas, United States, 67208 | |
| Consultants in Pulmonary Medicine | |
| Olathe, Kansas, United States, 66061 | |
| United States, Massachusetts | |
| Boston University School of Medicine | |
| Boston, Massachusetts, United States, 02118 | |
| Beth Israel Deaconness Medical Center | |
| Boston, Massachusetts, United States, 02215 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| University of Minnesota | |
| Minneapolis, Minnesota, United States, 55455 | |
| United States, Missouri | |
| St. Luke's Medical Group, Cardio-Pulmonary Research | |
| Chesterfield, Missouri, United States, 63017 | |
| United States, New Jersey | |
| Pulmonary & Allergy Associates PA | |
| Summit, New Jersey, United States, 07901 | |
| United States, New York | |
| Highland Hospital - Pulmonary Department | |
| Rochester, New York, United States, 14602 | |
| Mount Sinai School of Medicine | |
| New York, New York, United States, 10029-6574 | |
| United States, North Carolina | |
| Duke University-ID/Pulmonary Research-Park garage 2; Room 0002 | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| University of Cinicinnati | |
| Cincinnati, Ohio, United States, 45267 | |
| The Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44195 | |
| United States, Pennsylvania | |
| Temple University | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| University of Pennsylvania Medical Center | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| United States, Tennessee | |
| Vanderbilt Medical Center- IPF Center | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| University of Texas-Southwestern Dallas-Div of Pulm & Critical Care Unit | |
| Dallas, Texas, United States, 75390 | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| United States, Utah | |
| University of Utah | |
| Salt Lake City, Utah, United States, 84108 | |
| United States, Vermont | |
| Vermont Lung Center | |
| Colchester, Vermont, United States, 05446 | |
| United States, Virginia | |
| Inova Heart and Vascular Institute | |
| Falls Church, Virginia, United States, 22042 | |
| University of Virginia - Division of Pulmonary and Critical Care | |
| Charlottesville, Virginia, United States | |
| United States, Washington | |
| University of Washington Medical Center | |
| Seattle, Washington, United States, 98195 | |
| United States, Wisconsin | |
| University of Wisconsin-Madison | |
| Madison, Wisconsin, United States, 53792-3240 | |
| Australia, New South Wales | |
| St. Vincent's Public Hospital, Lung Transplantation & Respiratory Medicine | |
| Darlinghurst, New South Wales, Australia, 2010 | |
| Australia, Queensland | |
| Prince Charles Hospital- Lung Transplant, Thoraic Dept. | |
| Chermside, Queensland, Australia, 4032 | |
| Australia, South Australia | |
| Royal Adelaide Hospital-Respiratory Clinical Trials Unit | |
| Adelaide, South Australia, Australia, 5000 | |
| Australia, Western Australia | |
| Royal Perth Haspital; Advanced Lung Disease Unit | |
| Perth, Western Australia, Australia, 6000 | |
| Austria | |
| Medical University of Vienna and AKH-Div of Pulmonology | |
| Wien, Austria, 1090 | |
| Medical University of Innsbruck-Dic of Clinical & Internal Medicine | |
| Innsbruck, Austria, 6020 | |
| Landesklinikum Thermenregion Hochegg | |
| Grimmenstein, Austria, 2840 | |
| Belgium | |
| UZ Gasthuisberg | |
| Leuven, Belgium, 3000 | |
| Canada, Alberta | |
| Walter C. Mackenzie Health Sciences Centre-University of Alberta | |
| Edmonton, Alberta, Canada, T6G 2B7 | |
| Canada, British Columbia | |
| St. Paul's Hospital - Pacific Lung Research Center | |
| Vancouver, British Columbia, Canada, V6Z 1Y6 | |
| Kelowna General Hospital | |
| Kelowna, British Columbia, Canada, V1YE4 | |
| Canada, Newfoundland and Labrador | |
| The Health Care Corporation of St. John's-Eastern Health | |
| St. John's, Newfoundland and Labrador, Canada, A1B 3V6 | |
| Canada, Ontario | |
| Toronto General Hospital-Rosedale Medical Center PFT Lab | |
| Toronto, Ontario, Canada, M4X 1W4 | |
| Lawson Health Research Institute | |
| London, Ontario, Canada, N6A 4G5 | |
| St. Joseph's Healthcare Hamilton | |
| Hamilton, Ontario, Canada, L8N 4A6 | |
| Canada, Quebec | |
| Institut de Cardiologie et de Pneumologie de l'Universite Laval | |
| Ste-Foy, Quebec, Canada, G1V 4G5 | |
| Croatia | |
| University Hospital for Lung Disease "Jordanovac" | |
| Zagreb, Croatia, 10000 | |
| Czech Republic | |
| University Hospital Na Bulovce | |
| Praha 8, Czech Republic, 180 81 | |
| University Hospital-Department of Respiratory Disease-IP Pavlova | |
| Olomouc, Czech Republic, 77520 | |
| Thomayer Faculty Hospital Prague-Dept of Respiratory Disease | |
| Praha 4, Czech Republic, 140 59 | |
| France | |
| Hopital Louis Pradel | |
| Bron, France, 69677 | |
| Hopital Avicenne | |
| Bobigny, France, 93009 | |
| HYLAB, Clinique du Mail | |
| Grenoble, France, 38100 | |
| CHU Hôpital Arnaud de Villeneuve | |
| Montpellier, France, 34295 | |
| Hopital Bichat | |
| Paris, France, 75877 | |
| CHRU de Lille-Hopital Albert Calmette | |
| Lille Cedex, France, 59037 | |
| Germany | |
| SKlinikum der Universität München Medizinische Klinik und Poliklinik 1 - Grosshadern | |
| Munich, Germany, 81377 | |
| Justus-Liebig-Universitat Giessen-Zentrum für Innere Medizin | |
| Giessen, Germany, 35392 | |
| Fachkrankenhaus Coswig; Centre for Pumonology and Thoracic Surgery | |
| Coswig, Germany | |
| Ruhrlandklinik Pneumologie/Allergologie | |
| Essen, Germany, 45239 | |
| HELIOS Klinikum Emil von Behring | |
| Berlin, Germany, D-14165 | |
| Fachklinik fur Lungenerkrankungen | |
| Immenhausen, Germany | |
| Thoraxklinik Heidelberg GmbH | |
| Heidelberg, Germany, 01640 | |
| Lungenfachklinik Immenhausen; Pneumologische Lehrklinik der Universität Göttingen | |
| Immenhausen, Germany | |
| Klinik Löwenstein GmbH-Medizinische Klinik 1 Pnemologie Kardiologie | |
| Löwenstein, Germany, 74245 | |
| Klinik Donaustauf-Zentrum für Pneumologie | |
| Donaustauf, Germany, 93093 | |
| Ireland | |
| Mater Misicordiae University Hospital | |
| Dublin, Ireland, 7 | |
| Israel | |
| Sheba Medical Centre-Pulmonology Institute | |
| Tel-Hashomer, Israel, 52621 | |
| Kaplan Medical Centre-Pulmonary Istitute | |
| Rehovot, Israel, 76100 | |
| Tel-Aviv Sourasky Medical Centre-Institute of Pulmonary & Allergy Diseases | |
| Tel-Aviv, Israel, 64239 | |
| Hadassah medical Centrte: Ein Karem-Institue of Pulmonology | |
| Jerusalem, Israel, 91120 | |
| Rabin Medical Centre-Beilinson Campus-Pulmonary Istitute | |
| Petach Tikvah, Israel, 49100 | |
| Rambam Medical Centre-Div. for Pulmonary Disease | |
| Haifa, Israel, 31096 | |
| Pulmonary Institute-Rabin Medical Center: Beilinson Campus | |
| Petach Tikvah, Israel, 49100 | |
| Italy | |
| Azienda Ospedaliero-Universitaria San Luigi Gonzaga | |
| Orbassano (Torino), Italy, 10043 | |
| Azienda Ospedaliera di Padova - Immunologia Clinica | |
| Padova, Italy, 35128 | |
| Azienda Sanitaria di Forli-Presidio Ospedaliero Stabilimento | |
| Forli, Italy, 47100 | |
| Pneumologia ISMETT | |
| Palermo, Italy, 90127 | |
| Ospedale San Giuseppe Milanocuore, Unita Operativa di Pneumologia | |
| Milan, Italy, 20123 | |
| University degli Studi Siena, Policlinico le Scotte | |
| Siena, Italy, 53100 | |
| Japan, Aichi | |
| Tosei General Hospital | |
| Seto, Aichi, Japan, 489-8642 | |
| Japan, Hyogo | |
| Himeji medical center | |
| Himeji, Hyogo, Japan, 670-8520 | |
| Japan, Kanagawa | |
| Kanagawa Cardiovascular Respiratory Center | |
| Yokohama, Kanagawa, Japan, 236-0051 | |
| Japan, Nara | |
| Tenri Hospital | |
| Tenri, Nara, Japan, 632-8552 | |
| Japan, Osaka | |
| Kinki - Chuo Chest Medical Center | |
| Sakai, Osaka, Japan, 591-8555 | |
| Korea, Republic of | |
| Samsung Medical Center | |
| Seoul, Korea, Republic of, 135-710 | |
| Asan Medical Center | |
| Seoul, Korea, Republic of, 138-736 | |
| Gil Medical Centre, Gachon University | |
| Incheon, Korea, Republic of, 405-760 | |
| Seoul National University Hospital | |
| Seoul, Korea, Republic of, 110-744 | |
| Soon Chun Hyang University Bucheon Hospital | |
| Seoul, Korea, Republic of, 420-767 | |
| Netherlands | |
| Academisch Medisch Centrum Amsterdam | |
| Amsterdam, Netherlands, 1105 AZ | |
| Serbia | |
| Institut za Plucne bolest 1 TBC Klinickog Centra Srbije | |
| Belgrade, Serbia, 11000 | |
| Institut za Plucne bolesti Vojodine | |
| Sremska Kamenica, Serbia, 21204 | |
| Spain | |
| Hospital La Princesa | |
| Madrid, Spain, 28006 | |
| Hospital General de Valencia | |
| Valencia, Spain, 46014 | |
| Hospital Universitario Ramon y Cajal | |
| Madrid, Spain, 28034 | |
| Hospital General Vall d'Hebron-Neumologia | |
| Barcelona, Spain, 08035 | |
| Hospital Universitario Dr. Peset | |
| Valencia, Spain, 46017 | |
| Hospital Clinico San Carlos | |
| Madrid, Spain, 28040 | |
| Hospital Clinic Barcelona (Pneumology Service) | |
| Barcelona, Spain, 08036 | |
| Switzerland | |
| Inselspital Bern-Div of Pulmonary Medicine | |
| Bern, Switzerland, 3010 | |
| University Hospital Basel-Div of Pneumology | |
| Basel, Switzerland, 4031 | |
| University Hospital Zurich-Clinic for Pneumology & Lung Transplant Program | |
| Zurich, Switzerland, 8091 | |
| United Kingdom | |
| Wythenshawe Hospital | |
| Manchester, United Kingdom, M23 9LT | |
| Southmead Hospital | |
| Bristol, United Kingdom, BS105NB | |
| Royal Brompton Hospital | |
| London, United Kingdom | |
| Papworth Hospital | |
| Cambridgeshire, United Kingdom, CB23 3RE | |
| Aberdeen Royal Infirmary | |
| Aberdeen, United Kingdom, AB252ZN | |
| Study Chair: | Isabelle Leconte | Actelion |
More Information
| Responsible Party: | Actelion ( Sponsor ) |
| Study ID Numbers: | AC-052-322 |
| Study First Received: | February 12, 2008 |
| Last Updated: | October 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00631475 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
|
bosentan Tracleer Actelion |
BUILD 3 Idiopathic Pulmonary Fibrosis Interstitial Lung Disease |
|
Lung Diseases, Interstitial Pathologic Processes Respiratory Tract Diseases Fibrosis Therapeutic Uses Lung Diseases |
Cardiovascular Agents Antihypertensive Agents Pulmonary Fibrosis Pharmacologic Actions Bosentan |
