Clinical Trial Results:
Multizentrische, prospektive, einarmige Phase III-Studie zur Wirksamkeit und Sicherheit einer oralen Therapie mit Propranolol (ProAngiol Saft; 2 mg/kg KG/d mit fakultativer Dosiserhöhung auf 3 mg/kg KG/d) bei Säuglingen im Alter von 4 Wochen bis 11 Monaten mit schweren, proliferierenden Hämangiomen
Summary
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EudraCT number |
2010-019754-41 |
Trial protocol |
DE |
Global completion date |
15 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 |
01 Mar 2020
|
First version publication date |
01 Mar 2020
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Other versions |
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Summary report(s) |
EudraCT-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.