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Efficacy and safety of oral bosentan in patients with Idiopathic Pulmonary Fibrosis Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Efficacy and safety of oral bosentan in patients with Idiopathic Pulmonary Fibrosis conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Efficacy and safety of oral bosentan in patients with Idiopathic Pulmonary Fibrosis Clinical research trials and Efficacy and safety of oral bosentan in patients with Idiopathic Pulmonary Fibrosis health trials happen in many of localities throughout the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically measure the effectualness of new drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Efficacy and safety of oral bosentan in patients with Idiopathic Pulmonary Fibrosis. Efficacy and safety of oral bosentan in patients with Idiopathic Pulmonary Fibrosis Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Efficacy and safety of oral bosentan in patients with Idiopathic Pulmonary Fibrosis clinical trial. Human subjects often get the best healthcare available for their Efficacy and safety of oral bosentan in patients with Idiopathic Pulmonary Fibrosis condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "E" Clinical Trials Conditions > Efficacy and safety of oral bosentan in patients with Idiopathic Pulmonary Fibrosis Efficacy and safety of oral bosentan in patients with Idiopathic Pulmonary Fibrosis
Efficacy and safety of oral bosentan in patients with Idiopathic Pulmonary Fibrosis
For Condition: Idiopathic Pulmonary Fibrosis
Status: Recruiting
Sponsor(s): Actelion ,
Synopsis: Endothelin-1 (ET-1) is expressed in a variety of pulmonary pathological conditions including pulmonary vascular disease and pulmonary fibrosis. Bosentan (an oral dual ET-1 receptor antagonist) could delay the progression of idiopathic pulmonary fibrosis (IPF), a condition for which no established treatment is available. The present trial investigates a possible use of bosentan, which is currently approved for the treatment of symptoms of pulmonary arterial hypertension (PAH) WHO class III and IV, to a new category of patients suffering from IPF.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: Main inclusion criteria: - IPF proven diagnosis < 3 years, according to ATS/ERS consensus statement (with or without surgical lung biopsy). - Six-minute walk distance limited by dyspnea. Main exclusion criteria: - Interstitial Lung Disease (ILD) due to conditions other than IPF. - FVC < 50% predicted or < 1.2 liter. - DLco < 30 % of predicted. - Severe obstructive lung disease. - PaO2 < 55 mmHg. - Treatments with immunosuppressive, antifibrotic drugs, high dose corticosteroids (within 4 weeks from randomization). - Significant pulmonary arterial hypertension.
Total Enrollment:
Location and Contact Information:
Rosedale Medical Center *Recruiting*
Toronto, Ontario,
Canada
Recruiting Charles Chan 416-340-3235
Jackson Memorial Hospital *Not yet recruiting*
Miami, Florida,
United States
Not yet recruiting Marylin Glassberg 305-243-6388
Medizinische Klinik und Poliklinik I Klinikum der Universität München *Recruiting*
MĂĽnchen, ,
Germany
Recruiting JĂĽrgen Behr + 49 89-70-95-30-71
University of Pennsylvania *Recruiting*
Philadelphia, Pennsylvania,
United States
Recruiting Milton Rossman 215-615-0276
Vanderbilt University Medical Center *Recruiting*
Nashville, Tennessee,
United States
Recruiting Lisa Lancaster 615-754-0315
University of Alabama at Birmingham - Pulmonary Division *Recruiting*
Birmingham, Alabama,
United States
Recruiting Joao DeAndrade 205-934-7557
University of British Columbia - St. Paul's Hospital *Recruiting*
Vancouver, British Columbia,
Canada
Recruiting Robert Levy 604-806-8931
University of California - Ambulatory Care Center *Recruiting*
San Francisco, California,
United States
Recruiting Jeffrey Golden 415-353-2935
Yale University School of Medicine *Recruiting*
New Haven, Connecticut,
United States
Recruiting Paul Noble 203-785-7324
HĂ´pital Louis Pradel *Recruiting*
Lyon, , 69000
France
Recruiting Jean Cordier + 33 472 357 652
David Geffen School of Medicine at UCLA - Division of Pulmonary and Critical Care Medicine *Recruiting*
Los Angeles, California,
United States
Recruiting David Zisman 310-825-8689
Sheba Medical Center *Recruiting*
Tel Hashomer, ,
Israel
Recruiting Issahar Dov + 972 35-30-27-35
Abt. Pneumologie Medizinische Klinik Universitätsklinikum Freiburg *Recruiting*
Freiburg, ,
Germany
Recruiting Joachim MĂĽller-Quernheim + 49 761-270-37-06
Mayo Medical School - Mayo Clinic *Recruiting*
Rochester, Minnesota,
United States
Recruiting Sanjay Kalra 507-284-2447
Section of Respiratory Diseases - Policlinico Le Scotte - Siena University *Recruiting*
Siena, ,
Italy
Recruiting Paola Rottoli + 39 0577-586-710
University of Michigan Health System - Division of Pulmonary & Critical Care Medicine *Recruiting*
Ann Arbor, Michigan,
United States
Recruiting Fernando Martinez 734-763-2540
Klinik Löwenstein gGmbH *Recruiting*
Löwenstein, ,
Germany
Recruiting Gerd Stähler + 49 7130-15-208
New York Presbyterian Medical Center for Chest Disease *Recruiting*
New York City, New York,
United States
Recruiting Neil Schluger 212-305-1158
University of Wisconsin Hospitals & Clinics - Section of Pulmonary and Critical Care Medicine *Recruiting*
Madison, Wisconsin,
United States
Recruiting Keith Meyer 608-263-6363
Notre-Dame Hospital - Clinique du Thorax *Recruiting*
Montreal, Quebec,
Canada
Recruiting Charles Poirier +1 514-890-8000
University of Iowa Hospitals & Clinics - Department of Internal Medicine *Recruiting*
Iowa City, Iowa,
United States
Recruiting Gary Hunninghake 415-353-2935
Royal Brompton Hospital *Not yet recruiting*
London, ,
United Kingdom
Not yet recruiting Athol Wells +44 207-352- 81-21
Inselspital *Recruiting*
Bern, ,
Switzerland
Recruiting Thomas Geiser + 41 31-632-27-68
National Jewish Medical and Research Center *Recruiting*
Denver, Colorado,
United States
Recruiting Kevin Brown 303-398-1621
University of Washington - Division of Pulmonary & Critical Care Medicine *Recruiting*
Seattle, Washington,
United States
Recruiting Ganesh Raghu 206-598-4967
UCSD Medical Center *Recruiting*
San Diego, California,
United States
Recruiting Gordon Yung 619-543-7300
Médecine Spécialisée Aigüe - CHU Grenoble *Recruiting*
Grenoble, , 38043
France
Recruiting Christophe Pison + 33 476 76 87 32
Tulane University Health Sciences Center *Recruiting*
New Orleans, Louisiana,
United States
Recruiting Chodie Gabor 504-585-6966
Hôpital Avicenne - Université de Paris *Recruiting*
Bobigny, ,
France
Recruiting Dominique Valeyre + 33 1-48-95-51-21
University of Pittsburgh *Not yet recruiting*
Pittsburgh, Pennsylvania,
United States
Not yet recruiting James Dauber 412-648-6161
Baylor College of Medicine *Recruiting*
Houston, Texas,
United States
Recruiting Adaani Frost 713-790-2076
Additional Information:
Study ID Numbers: BUILD 1; AC-052-320
Study Start Date: August 2003
Record last reviewed: January 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00071461
Other Idiopathic Pulmonary Fibrosis Studies:
1. A Study of the Safety and Clinical Effects of Interferon gamma-1b in Patients with Idiopathic Pulmonary Fibrosis (IPF)
2. Pirfenidone for the Treatment of Patients with Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis (PF/IPF)
3. Efficacy and safety of oral bosentan in patients with Idiopathic Pulmonary Fibrosis
4. The INSPIRE Trial: A Study of Interferon gamma-1b for Idiopathic Pulmonary Fibrosis (IPF)
5. A study of the safety and efficacy Interferon-gamma 1b in patients with Idiopathic Pulmonary Fibrosis (IPF)
Related Studies:
Other Idiopathic Pulmonary Fibrosis Clinical Trials
Other Clinical Trials
Other Siena Clinical Trials
Efficacy and safety of oral bosentan in patients with Idiopathic Pulmonary Fibrosis
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