Clinical Trial Results:
RANDOMIZED, DOUBLE-BLIND, ACTIVE CONTROLLED, 3-ARM PARALLEL GROUP, MULTI-NATIONAL, MULTI-CENTRE STUDY TO EVALUATE THE CARDIAC SAFETY OF TWO DOSES OF GLYCOPYRROLATE BROMIDE (25µG AND 50µG BID) DELIVERED VIA HFA PMDI BOTH COMBINED WITH FOSTER® 100/6 µG BID DELIVERED VIA HFA PMDI VERSUS FOSTER® 100/6 µG BID DELIVERED VIA HFA PMDI IN PATIENTS WITH MODERATE TO SEVERE COPD
Summary
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EudraCT number |
2011-004759-37 |
Trial protocol |
HU DE GB PL BG |
Global completion date |
27 Sep 2012
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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 |
06 Jan 2017
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First version publication date |
06 Jan 2017
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Other versions |
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Summary report(s) |
EudraCT No. 2011-004759-37 ICH E3 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.