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Study to Evaluate the Safety, Efficacy and Pharmacokinetics of Optimark (Gadoversetamide) in Pediatric Patients

2014-07-23 21:09:44 | BioPortfolio

Summary

The objective of this study is to characterize the safety, efficacy and pharmacokinetic profiles of Optimark at the standard clinical dose of 0.1 mmol/kg in the pediatric patient population.

Description

Pediatric patients referred for magnetic resonance imaging (MRI) of the liver or central nervous system (CNS) will be stratified by age to one of two groups (2 through 11 and 12 through 18 years of age).

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Conditions

Pathological Processes

Intervention

MRI, MRI, Gadoversetamide

Location

Arkansas Childrens Hospital
Little Rock
Arkansas
United States
72201

Status

Completed

Source

Mallinckrodt

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-07-23T21:09:44-0400

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