Trial Condition(s):

Central nervous system diseases

Efficacy and safety study to evaluate Gadavist (Gadobutrol) as contrast agent in Magnetic Resonance Imaging (MRI) of brain or spine diseases in Chinese patients

Bayer Identifier:

91536

ClinicalTrials.gov Identifier:

NCT00395460

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

Inclusion Criteria
- Chinese origin, with known or suspected brain or spine diseases
Exclusion Criteria
- Pregnancy
 - Lactation
 - Conditions interfering with  MRI
 - Allergy to any contrast agent or any drugs
 - Participation in other trial
 - Require emergency treatment
 - Severely impaired liver and kidney functions

Trial Summary

Enrollment Goal
147
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Gadavist/Gadovist (Gadobutrol, BAY86-4875)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Shanghai, China, 200040

Status
Completed
 
Locations

Investigative Site

Beijing, China, 100853

Status
Completed
 
Locations

Investigative Site

Nanjing, China, 210029

Status
Completed
 
Locations

The 1st Affiliated Hosp of the 4th Military Med Uni

Xi'an, China, 710032

Status
Completed
 

Trial Design