Clinical Trial Results:
Multicenter, open-label study to evaluate the safety and efficacy (by blinded reading) of Gadobutrol-enhanced magnetic resonance angiography (MRA) after a single injection of 0.1 mmol/kg of Gadobutrol in subjects with known or suspected renal artery disease
Summary
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EudraCT number |
2010-023002-13 |
Trial protocol |
CZ DE AT |
Global completion date |
06 Jul 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 |
This version publication date |
12 Jul 2016
|
First version publication date |
09 Nov 2014
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Other versions |
v2 , v3 |
Summary report(s) |
Bayer Study 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.