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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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29 August 2016 |
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Main ID: |
NCT01447550 |
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Date of registration:
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05/10/2011 |
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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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Treatment of Thromboangiitis Obliterans (Buerguer's Disease) With Bosentan
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Scientific title:
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Treatment of Thromboangiitis Obliterans (Buerger's Disease) With Bosentan |
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Date of first enrolment:
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January 2009 |
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Target sample size:
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12 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT01447550 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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Spain
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Contacts
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Name:
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Joaquin De Haro, MD,PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hospital Universitario de Getafe |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Critical ischemia in any extremity, causing pain at rest or non-healing ischemic
ulcers, present for at least four weeks with no evidence of improvement in response
to conventional treatment.
Exclusion Criteria:
- Being candidates for surgical or endovascular revascularisation of the extremity
studied.
Age minimum:
18 Years
Age maximum:
65 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Thromboangiitis Obliterans
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Intervention(s)
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Drug: Bosentan
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Primary Outcome(s)
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Clinical improvement rate
[Time Frame: 4-6 months]
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Secondary Outcome(s)
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haemodynamics, endothelial function and angiographic changes
[Time Frame: 4-6 months]
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Secondary ID(s)
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Buerger-Bosentan
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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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