Clinical Trial Results:
A randomized, double-blind, placebo-controlled, infusion proof-of-concept trial investigating the safety, tolerability, pharmacokinetics, and pharmacodynamics of ascending doses of FE 202158 in patients with vasodilatory hypotension in early septic shock
Due to the EudraCT – Results system being out of service between 31 July 2015 and 12 January 2016, these results have been published in compliance with revised timelines
Summary
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EudraCT number |
2009-010798-19 |
Trial protocol |
BE DK |
Global completion date |
14 Sep 2011
|
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 |
29 Dec 2016
|
First version publication date |
29 Dec 2016
|
Other versions |
|
Summary report(s) |
FE 202158 CS02 summary report |
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.