drugset / Trial / NCT00709852

Safety and Efficacy of Gadobutrol 1.0 Molar (Gadavist) in Patients for Central Nervous System (CNS) Imaging

NCT00709852

Phase 3 Completed 402 enrolled Bayer
RandomizedCrossoverQuadruple-blindDiagnostic

Summary

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

Timeline

Start
2008-06
Primary completion
2009-04
Completion
2009-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Gadobutrol Diagnostic / imaging agent 0.1 unknown Intravenous
Subject Gadoteridol Diagnostic / imaging agent 0.1 unknown Intravenous