drugset / Trial / NCT00395460

Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Brain or Spine Diseases in Chinese Patients

NCT00395460

Phase 3 Completed 147 enrolled Bayer
RandomizedParallel-groupSingle-blindDiagnostic

Summary

The purpose of this study is to determine if the contrast agent is effective and safe in the Magnetic Resonance Imaging (MRI) of brain or spine diseases in patients of Chinese origin.

Timeline

Start
2006-09
Primary completion
2007-04
Completion
2007-04

Publications

  • Results Liang Z; Ma L; Wang D; Huan Y; Li P; Yu J; Yao Z; Chen S; He H; Feng X and Breuer J. Efficacy and Safety of Gadobutrol (1.0 M) versus Gadopentetate Dimeglumine (0.5 M) for Enhanced MRI of CNS Lesions: A Phase III, Multicenter, SingleBlind, Randomized Study in Chinese Patients. Magnetic Resonance Insights 2012; 5:17-28

Drugs

EvaluationDrugModalityDoseRoute
Subject Gadobutrol Diagnostic / imaging agent 0.1 unknown Intravenous
Comparator Gadopentetate dimeglumine Diagnostic / imaging agent 0.2 unknown Intravenous