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Safety and Efficacy of Gadobutrol 1.0 Molar in Japanese Subjects for CNS Imaging

Magnetic Resonance Imaging Clinical Trial

Official title:
A Multicenter, Open-label, Phase III Study to Determine the Safety and Efficacy of Gadobutrol 1.0 Molar in Japanese Subjects Referred for Contrast-enhanced MRI of the Central Nervous System (CNS)

Clinical Trial Summary

Purpose of the 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 images of the brain and spine. The results of the Magnetic Resonance Imaging (MRI) will be compared to the results of images taken without contrast (gadobutrol).

Clinical Trial Description

n/a

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01660841
Study type Interventional
Source Bayer
Contact
Status Completed
Phase Phase 3
Start date September 2012
Completion date August 2013
View Details
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