Clinical Trial Results:
A single-blind, placebo-controlled, multicentre study evaluating continued long-term treatment with satavaptan (SR121463B) in patients with ascites due to liver cirrhosis who have previously been treated in studies LTS5634 or LTS5635.
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Ensayo simple ciego, multicéntrico, controlado con placebo para evaluar el tratamiento contínuo a largo plazo con satavaptan (SR121463B) en pacientes con ascitis debida a cirrosis hepática que han sido tratados previamente en los estudios LTS5634 ó LTS5635
Summary
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EudraCT number |
2006-005753-29 |
Trial protocol |
ES FR BE CZ IT DE |
Global completion date |
03 Dec 2008
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Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
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Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
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Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
No
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Results information
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Results version number |
v1(current) |
This version publication date |
26 Oct 2016
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First version publication date |
26 Oct 2016
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Other versions |
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Summary report(s) |
LTS10209 |
Note: The legislation allows summary attachments to be posted instead of the full dataset for this trial. Refer to Commission Guideline 2012/C 302/03
for further information.