NCT00623467

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

A Multicenter, Open-label, Phase 3 Study to Determine the Safety and Efficacy of Gadobutrol 1.0 Molar (Gadavist) in Patients Referred for Contrast-enhanced MRI of the Central Nervous System (CNS).

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 343 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Issues on safety will be addressed in Adverse Events section.

Conditions

• Central Nervous System Diseases

Interventions

Type	Name	Description
DRUG	Gadobutrol (Gadavist, Gadovist, BAY86-4875)	Gadobutrol single injection 0.1 mmol/kg BW via IV bolus administration at 2mL/sec.

Timeline

• Start date: 2007-12-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2008-02-26
• Last updated: 2014-02-10
• Results posted: 2011-10-06

Locations

37 sites across 5 countries: United States, Argentina, China, Colombia, South Korea