Clinical Trial Results:
A Pilot Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Trial of the Safety, Efficacy, and Pharmacokinetics of Titrated Oral SAMSCA® (Tolvaptan) in Children and Adolescent Subjects With Euvolemic or Hypervolemic Hyponatremia
Summary
|
|
EudraCT number |
2014-001582-27 |
Trial protocol |
GB DE IT |
Global completion date |
|
Paediatric regulatory details
|
|
Is the trial part of an agreed EMA paediatric investigation plan? |
|
Is the trial in scope of article 45 of Regulation (EC) No 1901/2006? |
|
Is the trial in scope of article 46 of Regulation (EC) No 1901/2006? |
|
Results information
|
|
Results version number |
v1(current) |
This version publication date |
10 Sep 2021
|
First version publication date |
10 Sep 2021
|
Other versions |
|
Summary report(s) |
156-13-207 Sponsor Statement |
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.