Clinical Trial Results:
Randomized double blind trial to evaluate the efficacy and safety of dronedarone (400 mg BID) versus amiodarone (600 mg daily for 28 days then 200 mg daily thereafter) for at least 6 months for the maintenance of sinus rhythm in patients with atrial fibrillation (AF)
Summary
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EudraCT number |
2006-005804-15 |
Trial protocol |
CZ DE SE BE FI EE AT IT NL PL |
Global completion date |
03 Oct 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 |
01 May 2016
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First version publication date |
01 May 2016
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Other versions |
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Summary report(s) |
EFC4968 |
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.