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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
4
Intravenous
Intravenous
Children's Hospital of New York - Presbyterian
New York, New York, United States
Fundación Cardioinfantil - Instituto Cardiológico
Bogotá, Colombia
Fundación Valle del Lili
Cali, Valle, Colombia
Mean Change From Baseline to the End of the 48-hour Treatment Period in Serum Sodium
Time frame: baseline and 48 hours
Time From the First Dose of Study Medication to a Confirmed ≥ 4 mEq/L Increase From Baseline in Serum Sodium
Time frame: 48 hours
Number of Patients With Confirmed ≥ 4 mEq/L Increase From Baseline in Serum Sodium
Time frame: baseline and 48 hours
Number of Subjects With Confirmed > 6 mEq/L Increase From Baseline in Serum Sodium or a Confirmed Normal Serum Sodium Level (Greater Than or Equal to 135 mEq/L)
Time frame: baseline and 48 hours
Change From Baseline in Effective Water Clearance (EWC) Every 12 Hours
Time frame: Baseline, Hours 12, 24, 36 and 48
Change From Baseline in Free Water Clearance (FWC)
Time frame: Baseline and 48 hours
Number of Participants With an Overly Rapid Rise in Serum Sodium From Baseline
an absolute serum sodium of 145 mEq/L at Hour 24 or an increase in serum sodium of greater than 12 mEq/L
Time frame: baseline and Hours 3, 8, 12 and 24.
Population Pharmacokinetics: Clearance (CL)
Based on conivaptan concentrations, the pharmacokinetics of the study population will be analyzed to determine median CL
Time frame: Up to Hour 60
Population Pharmacokinetics: Volume of Distribution (Vd)
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Based on conivaptan concentrations, the pharmacokinetics of the study population will be analyzed to determine median Vd
Time frame: Up to Hour 60