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
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EudraCT number |
2004-000452-16 |
Trial protocol |
HU CZ ES IT |
Global completion date |
22 Oct 2009
|
Paediatric regulatory details
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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
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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 |
05 Nov 2016
|
First version publication date |
05 Nov 2016
|
Other versions |
v2 |
Summary report(s) |
156-03-244 CSR 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.