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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 |
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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.