Conditions: Hyponatremia
Keywords: Serum Sodium Euvolemia Hypervolemia Vaprisol® Conivaptan YM087
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 4
Healthy volunteers: no

Brief summary:
The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of intravenous conivaptan in pediatric subjects with abnormally low concentration of sodium in blood.

Detailed description:
A 3:1 randomization between conivaptan and placebo will be implemented and randomization will be further stratified in a 1:1:2 ratio for age groups: 2-5 years, 6-10 years, and 11-17 years.

Subjects will need to remain hospitalized for the 48-hour Treatment Period through Hour 96 (Day 4). There will be a follow-up safety visit on Day 9 or day of hospital discharge, whichever occurs first. There is a final follow-up phone call at Day 32 to assess if any serious adverse events have occurred since hospital discharge.

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Conivaptan hydrochloride intervention 2: Placebo
Intervention descriptions: intervention 1: Intravenous intervention 2: Intravenous

Protocol document: