NCT01451411

A Study to Assess the Efficacy, Safety and Pharmacokinetics of Intravenous Conivaptan (Vaprisol®) in Pediatric Subjects With Euvolemic or Hypervolemic Hyponatremia

A Phase III, Double-Blind, Randomized, Placebo-Controlled, Multi-Center, Dose-Titration Study to Assess the Efficacy, Safety and Pharmacokinetics of Intravenous Conivaptan (Vaprisol®) in Pediatric Subjects With Euvolemic or Hypervolemic Hyponatremia

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 4 (actual)
• Sponsor: Cumberland Pharmaceuticals · Industry
• Sex: All
• Age: 2 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hyponatremia

Interventions

Type	Name	Description
DRUG	Conivaptan hydrochloride	Intravenous
DRUG	Placebo	Intravenous

Timeline

• Start date: 2012-02-01
• Primary completion: 2014-01-01
• Completion: 2014-01-01
• First posted: 2011-10-13
• Last updated: 2016-03-01
• Results posted: 2016-03-01

Locations

3 sites across 2 countries: United States, Colombia