Clinical Trial Results:
A phase III, randomized, parallel-group, double-blind, active controlled study to investigate the efficacy and safety of two different dose regimens (75mg day 1 followed by 150 mg day 2-completion, and 110 mg day 1 followed by 220 mg day 2-completion) of dabigatran etexilate administered orally (capsules), compared to enoxaparin 30 mg twice a day subcutaneous for 12 – 15 days in prevention of venous thromboembolism in patients with primary elective total knee replacement surgery
Summary
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EudraCT number |
2005-001998-10 |
Trial protocol |
GB |
Global completion date |
26 Jun 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 |
22 Jun 2019
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First version publication date |
22 Jun 2019
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Other versions |
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Summary report(s) |
Synopsis |
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.