Clinical Trial Results:
A Phase 3, randomized, 6-month, double blind trial in subjects with Bipolar I Disorder to evaluate the continued safety and maintenance of effect of Ziprasidone plus a mood stabilizer (vs placebo plus a mood stabilizer) following a minimum of 4 months of response to open-label treatment with both agents.
Summary
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EudraCT number |
2005-004167-27 |
Trial protocol |
ES IT SE DE |
Global completion date |
23 May 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 |
27 Apr 2016
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First version publication date |
13 Feb 2015
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Other versions |
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Summary report(s) |
A1281137 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.