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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00070590 |
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Date of registration:
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06/10/2003 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy and Safety of Oral Bosentan in Pulmonary Fibrosis Associated With Scleroderma
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Scientific title:
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A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Assess the Efficacy, Safety and Tolerability of Bosentan in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis |
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Date of first enrolment:
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July 2003 |
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Target sample size:
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132 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00070590 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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Phase:
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Phase 2/Phase 3
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Countries of recruitment
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France
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Germany
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Israel
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Italy
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Netherlands
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Sweden
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Switzerland
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United Kingdom
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United States
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Key inclusion & exclusion criteria
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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)
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Pulmonary Fibrosis
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Scleroderma, Systemic
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Intervention(s)
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Drug: Bosentan
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Primary Outcome(s)
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Change from baseline to End-of-Study in 6-minute walk distance.
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Secondary Outcome(s)
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Time to death (all causes) or to worsening of PFTs up to End-of-Study.
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Worsening of PFTs (on 2 consecutive tests at least 4 weeks apart) is defined as: decrease from baseline = 10% in FVC OR decrease from baseline = 15% in DLco AND = 6% in FVC
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Secondary ID(s)
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BUILD 2
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AC-052-330
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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