Clinical Trial Results:
International, multicenter, randomized, parallel group, double-blind study, in patients with acute symptomatic deep vein thrombosis of the lower limbs, demonstrating the bioequipotency at steady state of equimolar doses of SSR126517E (3.0 mg) once a week and SR34006 (2.5 mg) once a week, documenting the safety and efficacy of both compounds during a 6-month treatment, and demonstrating the neutralizing effect of SSR29261 on the SSR126517E-induced anti-Xa activity.
Summary
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EudraCT number |
2005-005326-30 |
Trial protocol |
AT DK BE ES CZ IT |
Global completion date |
31 Jan 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 |
08 Jun 2016
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First version publication date |
08 Jun 2016
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Other versions |
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Summary report(s) |
EFC5945 |
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.