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
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Mean change from baseline to Hour 48 in serum sodium as compared to placebo
Baseline and Hour 48
No
Medical Director
Study Director
Astellas Pharma Global Development
United States: Food and Drug Administration
087-CL-096
NCT01451411
February 2012
February 2016
Name | Location |
---|---|
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
Hackensack University Medical Center | Hackensack, New Jersey 07601 |
University of Kentucky | Lexington, Kentucky 40536-0098 |
Robert Wood Johnson University Hospital | New Brunswick, New Jersey 08903 |
Arkansas Children's Hospital Research Institute | Little Rock, Arkansas 72202 |
Riley Children's Hospital | Indianapolis, Indiana 46202 |
Saint Louis Children's Hospital | Saint Louis, Missouri 63110 |
Children's Hospital of New York - Presbyterian | New York, New York 10032 |