Clinical Trial Results:
Prospective, randomized, national, multi-centre, open-label, blinded endpoint study to compare Aggrenox® b.i.d. (200 mg dipyridamole MR + 25 mg acetylsalicylic acid) when started within 24 hours of stroke onset on an acute stroke unit, and Aggrenox® b.i.d. when started after a 7-day therapy with ASA 100 mg once daily outside off an acute stroke unit, in symptomatic ischaemic stroke patients over a three months treatment period (EARLY) – An exploratory study
German title:
Prospektive, randomisierte, nationale, offene Multicenterstudie mit verblindeter Endpunktanalyse zum Vergleich von Aggrenox® Retardkapseln (200 mg Dipyridamol + 25 mg Acetylsalicylsäure) 2x täglich, Behandlungsbeginn innerhalb von 24 Stunden nach einem ischämischem Schlaganfall auf einer Stroke unit, versus Aggrenox® Retardkapseln b.i.d., Behandlungsbeginn außerhalb einer Stroke unit nach einer 7-tägigen Therapie mit 100 mg Acetylsalicylsäure pro Tag bei symptomatischen Patienten für einen Behandlungszeitraum von drei Monaten (EARLY) – Phase IV Studie
Summary
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EudraCT number |
2006-004870-28 |
Trial protocol |
DE |
Global completion date |
05 Feb 2009
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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 |
16 May 2016
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First version publication date |
06 May 2015
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Other versions |
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Summary report(s) |
9.182 |
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.