NCT01050829

Gadobutrol Magnevist-controlled Body Study

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)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 370 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Magnetic Resonance Imaging

Interventions

Type	Name	Description
DRUG	Gadobutrol (Gadovist, BAY86-4875)	Single administration at a dose of 0.1 mmol/kg
DRUG	Gadopentetate Dimeglumine (Magnevist, BAY86-4882)	Single administration at a dose of 0.1 mmol/kg

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2010-01-15
• Last updated: 2014-12-30

Locations

15 sites across 3 countries: China, Japan, South Korea