Clinical Trial Results:
(FONDACAST, del inglés FONDAparinux in patients with a plaster CAST)
Estudio Fase III, multicéntrico, aleatorizado, abierto, controlado, de dos grupos paralelos para evaluar la eficacia y seguridad de Fondaparinux frente a heparina de bajo peso molecular (Nadroparina) en pacientes que necesitan inmovilización rígida o semirígidasemirrígida al menos durante 21 días y hasta 45 días debido a una lesión aislada no quirúrgica por debajo de la rodilla.
Summary
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EudraCT number |
2008-004181-10 |
Trial protocol |
ES DE FR NL IT |
Global completion date |
04 Jul 2011
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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 |
12 Feb 2016
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First version publication date |
06 Nov 2014
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Other versions |
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Summary report(s) |
109350-FDAAA-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.