Clinical Trial Results:
A phase III randomised, parallel group, double-blind, active controlled
study to investigate the efficacy and safety of oral 220 mg dabigatran
etexilate (110 mg on the day of surgery followed by 220 mg once daily)
compared to subcutaneous 40 mg enoxaparin once daily for 28-35 days
in prevention of venous thromboembolism in patients following
primary elective total hip arthroplasty. (RE-NOVATE II)
Summary
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EudraCT number |
2007-002630-11 |
Trial protocol |
NL FI ES BE DE SE DK HU CZ AT IT |
Global completion date |
21 Sep 2009
|
Paediatric regulatory details
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Is the trial part of an agreed EMA paediatric investigation plan? |
No
|
Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
No
|
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 |
16 May 2016
|
First version publication date |
22 Mar 2015
|
Other versions |
|
Summary report(s) |
1160.64 |
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.