Clinical Trial Results:
A Randomized, Double-Blind, Placebo-Controlled Study to Explore the Efficacy and Safety of Risperidone Long-Acting Intramuscular Injectable in the Prevention of Mood Episodes in Bipolar I Disorder, with Open-Label Extension
Summary
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EudraCT number |
2004-003781-14 |
Trial protocol |
AT SK ES |
Global completion date |
20 Dec 2007
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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 |
05 Jun 2016
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First version publication date |
05 Jun 2016
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Other versions |
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Summary report(s) |
RISBMN3003 (2004-003781-14)_Risperidone_CSR Synopsis |
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.