drugset / Trial / NCT00862459

Dose Finding Study of Gadavist in Central Nervous System (CNS) Magnetic Resonance Imaging (MRI)

NCT00862459

Phase 2 Completed 237 enrolled Bayer
RandomizedParallel-groupTriple-blindDiagnostic

Summary

The purpose of this study is to look at the safety (what are the side effects) and efficacy (how well does it work) of Gadavist when used for taking images of the brain and spine. The results of the MRI with Gadavist Injection will be compared to the results of MR images taken without contrast and with the results of the MR images taken with OptiMARK.

Timeline

Start
2005-08
Primary completion
2007-03
Completion
2007-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Gadobutrol Diagnostic / imaging agent 0.03 mmol Intravenous
Subject Gadobutrol Diagnostic / imaging agent 0.1 mmol Intravenous
Subject Gadobutrol Diagnostic / imaging agent 0.3 mmol Intravenous
Subject Gadoversetamide Diagnostic / imaging agent 0.1 mmol