Clinical Trial Results:
A randomized, double blind, double dummy, parallel group,
placebo controlled study to evaluate the pharmacodynamic and
pharmacokinetic response and safety and tolerability of
SB424323 (250 mg, 375 mg and 500 mg) administered twice
daily for 16 weeks, on top of aspirin (325 mg, qd) in men and
women with non valvular atrial fibrillation at a low or
intermediate risk for stroke
Summary
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|
EudraCT number |
2005-001256-20 |
Trial protocol |
SE GB EE HU DK LV IT DE ES |
Global completion date |
21 Dec 2006
|
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 Feb 2016
|
First version publication date |
08 Nov 2014
|
Other versions |
|
Summary report(s) |
101724-Clinical-Study-Result-Summary |
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.