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Clinical Trial Results:
International, Multi-Centre, Study of One year, Open Label, Titrated Oral Tolvaptan Tablet Administration in Patients with Chronic Hyponatraemia: Extension to Studies 156-02-235 and 156-03-238 to assess One-year safety.

Summary
EudraCT number
2004-000452-16
Trial protocol
HU   CZ   ES   IT  
Global completion date
06 Jul 2005

Paediatric regulatory details
Is the trial part of an agreed EMA paediatric investigation plan?
No
Is the trial in scope of article 45 of Regulation (EC) No 1901/2006?
No
Is the trial in scope of article 46 of Regulation (EC) No 1901/2006?
No

Results information
Results version number
v2(current)
This version publication date
30 Dec 2016
First version publication date
05 Nov 2016
Other versions
v1
Version creation reason
  • Changes to summary attachments
redaction
Summary report(s)
156-03-238
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.
3
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