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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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11 May 2015 |
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Main ID: |
NCT00319033 |
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Date of registration:
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26/04/2006 |
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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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Open-label Study With Bosentan in Interstitial Lung Disease
BUILD 2 OL |
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Scientific title:
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Long-term Open-label Study in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis Who Completed the Protocol AC-052-330. |
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Date of first enrolment:
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July 2004 |
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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/NCT00319033 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, 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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Canada
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France
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Germany
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Israel
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Italy
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Korea, Republic of
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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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Inclusion Criteria:
- To have completed the 12-month treatment period of the AC-052-330/BUILD 2.
- Women should not be pregnant
- Women of childbearing potential must have a negative pre-treatment pregnancy test and
use a reliable method of contraception
- Signed informed consent prior to initiation of any study-mandated procedure
Exclusion Criteria:
- Any major violation of the protocol AC-052-330.
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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Interstitial Lung Disease
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Scleroderma
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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 all assessed time points in Borg dyspnea index, FVC and DLco, SpO2 at rest and de-saturation index (6-minute walk distance multiplied by SpO2 mean value).
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Change from baseline to all assessed time points in 6-minute walk test distance.
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Change from baseline to all assessed time points in SpO2 mean value, time to de-saturation (decrease in SpO2 = 4%), trough SpO2 and area under the curve during 6-minute walk test.
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Transition Dyspnea Index at all assessed time points.
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Secondary Outcome(s)
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Adverse events; serious adverse events.
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Secondary ID(s)
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AC-052-332
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BUILD 2 OL
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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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