drugset / Trial / NCT01092754

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

NCT01092754

Phase 4 Completed 100 enrolled Guerbet
Non-randomizedParallel-groupOpen-labelDiagnostic

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.

Timeline

Start
2002-05
Primary completion
2003-12
Completion
2003-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Gadoversetamide Diagnostic / imaging agent 0.1 mmol Intravenous

Indications

No indication recorded.