Who is sponsoring NCT00395460?

NCT00395460 is sponsored by Bayer.

What condition does NCT00395460 study?

NCT00395460 studies Central Nervous System Diseases.

What drugs are being tested in NCT00395460?

Interventions: Gadobutrol (Gadavist, Gadovist, BAY86-4875), Magnevist.

What is the status of NCT00395460?

NCT00395460 is currently COMPLETED.

Last reviewed 2015-05-13 · How we verify

A Single-blind, Multicenter, Randomized, Phase III Study of the Efficacy and Safety of Gadavist (1.0 M) in Comparison With Magnevist (0.5 M) as Contrast Agent for Enhanced Magnetic Resonance Imaging (MRI) of Central Nervous System (CNS) Lesions in Chinese Patients

NCT00395460 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Bayer
Phase	Phase 3
Status	COMPLETED
Enrolment	147
Start date	2006-09
Completion	2007-04

Conditions

Central Nervous System Diseases

Interventions

Gadobutrol (Gadavist, Gadovist, BAY86-4875)
Magnevist

Primary outcomes

Change in Contrast to Noise Ratio (CNR) Between Pre- and Post-contrast Magnetic Resonance Imaging (MRI) Scan of Central Nervous System (CNS) Lesions — Immediately before injection (pre-contrast) and 2-5 min after injection (post-contrast)
CNR = (signal intensity \[SI\] lesion - SI normal tissue) / standard deviation (SD) background. SI lesion is the signal intensity in the lesion, SI normal tissue is the signal intensity in the normal tissue, and SD background is the standard deviation of the background noise. The signal intensity (SI) on the pre-contrast and on the post-contrast MR scans was to be measured in the enhanced lesion, normal tissue and background.

Countries

China