Clinical Trial Results:
An open-label, long term multi-center study to assess the safety and efficacy of fixed dose combinations of solifenacin succinate (6 mg and 9 mg) with tamsulosin hydrochloride OCAS 0.4 mg, in male subjects with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH) with a substantial storage component
Summary
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EudraCT number |
2008-001212-20 |
Trial protocol |
NL AT IT DE FR HU SK BE CZ GB |
Global completion date |
14 Dec 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 |
17 Sep 2016
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First version publication date |
17 Sep 2016
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Other versions |
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Summary report(s) |
Results |
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.