A Multi-center/Multi-national, Randomized, Controlled, Single-blind, Group Comparison Phase 3 Study to Determine the Efficacy and Safety of Gadobutrol 1.0 Molar in Comparison to Magnevist Following Single Injection in Patients Referred for Contrast-enhanced MRI of the Body/Extremities Regions (Breast, Heart, Abdomen, Kidney, Pelvis, or Extremities)

NCT01050829 Phase 3 COMPLETED

The 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 MR images of the body/extremities regions. 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 Magnevist.

Details

Lead sponsor	Bayer
Phase	Phase 3
Status	COMPLETED
Enrolment	370
Start date	2010-01
Completion	2011-04

Conditions

• Magnetic Resonance Imaging

Interventions

• Gadobutrol (Gadovist, BAY86-4875)
• Gadopentetate Dimeglumine (Magnevist, BAY86-4882)

Primary outcomes

• The total score of the following 3 visualization parameters is used for primary variable: Degree of contrast enhancement; Border delineation; Internal morphology. — At Day 0

Countries

China, Japan, South Korea