Clinical Trial Results:
A phase III, randomised, parallel-group, double-blind, active controlled study to investigate the efficacy and safety of two different dose regimens of orally administered dabigatran etexilate capsules [150 or 220 mg once daily starting with a half dose (i.e.75 or 110 mg) on the day of surgery] compared to subcutaneous enoxaparin 40 mg once daily for 8+/-2 days, in prevention of venous thromboembolism in patients with primary elective total knee replacement surgery.
Summary
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EudraCT number |
2004-001317-34 |
Trial protocol |
FI SE DE AT HU DK CZ IT ES |
Global completion date |
15 May 2006
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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 |
13 May 2016
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First version publication date |
22 Mar 2015
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Other versions |
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Summary report(s) |
1160.25 |
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.