Clinical Trial Results:
A Randomized, Double-Blind, Active- and Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy and Safety of Flexibly-Dosed Extended-Release Paliperidone Compared with Flexibly-Dosed Quetiapine and Placebo in the Treatment of Acute Manic and Mixed Episodes Associated with Bipolar I Disorder
Summary
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EudraCT number |
2005-005812-25 |
Trial protocol |
LT GR |
Global completion date |
16 Nov 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 |
08 Apr 2016
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First version publication date |
08 Apr 2016
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Other versions |
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Summary report(s) |
R076477BIM3002_2005 005812 25_(Paliperidone) 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.