Hyponatremia Clinical Trial
Official title:
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
The purpose of this trial is to demonstrate that tolvaptan effectively and safely increases and maintains serum sodium concentrations in children and adolescent subjects with euvolemic or hypervolemic hyponatremia.
The purpose of the study is to also assess tolvaptan's pharmacokinetics (PK) and its effect
on fluid balance in children and adolescent subjects with euvolemic or hypervolemic
hyponatremia. Subjects who are diagnosed with euvolemic or hypervolemic hyponatremia (serum
sodium < 130 mEq/L [mmol/L]) that persists despite initial standard background therapy (eg,
including fluid restriction) are eligible to be screened for participation in this trial.
Subjects who demonstrate prior resistance to vasopressin antagonist therapy will be excluded.
All potential subjects must be deemed by the investigator as likely to benefit from a therapy
that raises serum sodium levels.
Subjects will be required to be in a hospital setting during initiation or titration of
tolvaptan. Overall, in this trial, subjects will undergo treatment with tolvaptan or placebo
for 30 (+2) days and a post-last dose follow-up phase of 14 days.
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