Clinical Trial Results:
A Phase 2, Multicenter, Open-Label Study to Evaluate the Response to and Safety of an 8-Day Course of Phenoptin Treatment in Subjects with Phenylketonuria Who Have Elevated Phenylalanine Levels
Summary
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EudraCT number |
2004-002071-16 |
Trial protocol |
IE DE GB IT |
Global completion date |
04 Nov 2005
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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 |
07 May 2023
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First version publication date |
07 May 2023
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Other versions |
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Summary report(s) |
PKU-001 Synopsis PKU-001 Substudy 01_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.