Clinical Trial Results:
A prospective, open label, randomized, multicenter, multinational study evaluating the overall efficacy and safety including the effect on renal function of sirolimus (Rapamune) replacing CNI in a standard care regimen of CNI, mycophenolate mofetil (MMF) and steroids in heart transplant patients
Summary
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EudraCT number |
2005-001183-31 |
Trial protocol |
ES AT CZ GB BE |
Global completion date |
06 Apr 2006
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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 |
02 Jun 2016
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First version publication date |
02 Jun 2016
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Other versions |
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Summary report(s) |
MT18328 CSR Synopsis Redacted |
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.