Clinical Trial Results:
Double blind placebo controlled dose ranging study of the efficacy and safety of celivarone at 50, 100 or 300 mg OD with Amiodarone as calibrator for the prevention of ICD interventions or death.
Summary
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EudraCT number |
2008-008412-47 |
Trial protocol |
DE FR HU ES PT BE SE NL IT PL FI CZ DK SK |
Global completion date |
12 May 2011
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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 |
01 Jun 2016
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First version publication date |
01 Jun 2016
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Other versions |
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Summary report(s) |
DRI10936 |
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.