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Efficacy and safety of oral bosentan in pulmonary fibrosis associated with scleroderma 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 pulmonary fibrosis associated with scleroderma conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Efficacy and safety of oral bosentan in pulmonary fibrosis associated with scleroderma Clinical research trials and Efficacy and safety of oral bosentan in pulmonary fibrosis associated with scleroderma 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 pulmonary fibrosis associated with scleroderma. Efficacy and safety of oral bosentan in pulmonary fibrosis associated with scleroderma 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 pulmonary fibrosis associated with scleroderma clinical trial. Human subjects often get the best healthcare available for their Efficacy and safety of oral bosentan in pulmonary fibrosis associated with scleroderma 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 pulmonary fibrosis associated with scleroderma  Efficacy and safety of oral bosentan in pulmonary fibrosis associated with scleroderma
Efficacy and safety of oral bosentan in pulmonary fibrosis associated with scleroderma
For Condition: Pulmonary Fibrosis,Scleroderma, Systemic
Status: Recruiting
Sponsor(s): Actelion ,
Synopsis: Clinical and experimental studies suggest that bosentan could delay the progression of interstitial lung disease (ILD) associated with systemic sclerosis (SSc), a condition for which no established efficacious treatment is available. The present trial investigates a possible use of oral 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 ILD associated with SSc.
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: - Systemic Sclerosis diffuse or limited - Significant Interstitial Lung Disease on HRCTscan - DLco < 80% predicted - Dyspnea on exertion - Walk not limited by musculoskeletal reasons Main exclusion criteria: - Interstitial Lung Disease due to other conditions than SSc - End stage restrictive or obstructive lung disease - Severe cardiac or renal diseases - Significant pulmonary arterial hypertension - Smoker (> 5cig./day) - Treatment with immunosuppressive, antifibrotic drugs, high dose corticosteroids (within 4 weeks of randomization)
Total Enrollment:
Location and Contact Information:
Ospedale Maggiore *Recruiting*
Milano, ,
Italy
Recruiting Raffaela Scorza +39 02 55 03 52 89
Boston Univ School of Medicine *Recruiting*
Boston, Massachusetts,
United States
Recruiting Joseph Korn 617-638-4486
Jefferson Medical College *Recruiting*
Philadelphia, Pennsylvania,
United States
Recruiting Sergio Jimenez 215-503-5042
HĂ´pital Saint Antoine *Recruiting*
Paris, ,
France
Recruiting Jean Cabane +33 1 49 28 23 87
Centre Hospitalier Universitaire *Recruiting*
Grenoble, ,
France
Recruiting Patrick Carpentier +33 4 76 76 89 60
Charité Universitätsklinikum *Recruiting*
Berlin, ,
Germany
Recruiting Gabriela Riemekasten +49 304 5051 3055
University Hospital *Recruiting*
Lund, ,
Sweden
Recruiting Anita Akesson +46 46 17 21 53
University Hospital *Recruiting*
ZĂśRICH, ,
Switzerland
Recruiting Pius BrĂĽhlmann +41 1 255 29 96
Georgetown University *Recruiting*
Washington D.C., District of Columbia,
United States
Recruiting Virginia Steen 202-444-2348
UCLA Med School *Recruiting*
Los Angeles, California,
United States
Recruiting Daniel Furst 310-794-9504
The Center for Rheumatology *Recruiting*
Albany, New York,
United States
Recruiting Lee Shapiro 518-489-4471
HĂ´pital Cochin *Recruiting*
Paris, ,
France
Recruiting Loic Guillevin +33 1 58 41 13 10
Policlinico Universitario *Recruiting*
Padova, ,
Italy
Recruiting Silvano Todesco +39 049 82 12 190
University of Pittsburgh *Recruiting*
Pittsburgh, Pennsylvania,
United States
Recruiting Thomas Medsger 412-383-8765
Health Medical Center *Recruiting*
Denver, Colorado,
United States
Recruiting David Collier 303-436-6902
College of Medicine *Recruiting*
Chicago, Illinois,
United States
Recruiting John Varga 312-413-9311
Medical School *Recruiting*
Houston, Texas,
United States
Recruiting Maureen Mayes 713-500-7118
University of Washington *Recruiting*
Seattle, Washington,
United States
Recruiting Ganesh Raghu 206-543-3166
Sint Maartenskliniek *Recruiting*
Nijmegen, ,
Netherlands
Recruiting Frank den Hoogen +31 24 36 59 275
Rabin Medical Center *Recruiting*
Petach Tikva, ,
Israel
Recruiting Mordechai Kramer +972-3-9377221
The Cleveland Clinic *Recruiting*
Cleveland, Ohio,
United States
Recruiting Soumya Chatterjee 216-444-9945
Instituto di Clinica, Villa Monna Tessa *Recruiting*
Firenze, ,
Italy
Recruiting Marco Cerinic +39 05 54 27 92 71
Royal Free Hospital *Recruiting*
London, ,
United Kingdom
Recruiting Carol Black +44 207 794 04 32
Jackson Memorial Hospital *Recruiting*
Miami, Florida,
United States
Recruiting Marylin Glassberg 305-243-6388
General Infirmary *Recruiting*
Leeds, ,
United Kingdom
Recruiting Paul Emery +44 113 392 50 68
CHRU Claude Huriez *Recruiting*
Lille, ,
France
Recruiting Eric Hachulla +33 320 44 42 96
UMDNJ *Recruiting*
New Brunswick, New Jersey,
United States
Recruiting James Seibold 732-235-7578
Virginia Mason Medical Center *Recruiting*
Seattle, Washington,
United States
Recruiting Jerry Molitor 206-223-6836
Medical Univ South Carolina *Recruiting*
Charleston, South Carolina,
United States
Recruiting Richard Silver 843-792-2014
Additional Information:
Study ID Numbers: BUILD 2; AC-052-330
Study Start Date: July 2003
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00070590
Other Pulmonary Fibrosis Studies:
1. Idiopathic Pulmonary Fibrosis: a Case-control Study
2. Pirfenidone for the Treatment of Patients with Pulmonary Fibrosis/Idiopathic Pulmonary Fibrosis (PF/IPF)
3. Clinical and Basic Investigations into Hermansky-Pudlak Syndrome
4. An Open-Label Study of the Safety of Interferon gamma-1b in Patients with IPF
5. Segmental Bronchoalveolar Lavage
Related Studies:
Other Pulmonary Fibrosis Clinical Trials
Other Texas Clinical Trials
Other Houston Clinical Trials
Efficacy and safety of oral bosentan in pulmonary fibrosis associated with scleroderma
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