Status:
COMPLETED
Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Brain or Spine Diseases in Chinese Patients
Lead Sponsor:
Bayer
Conditions:
Central Nervous System Diseases
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
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.
Detailed Description
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.
Eligibility Criteria
Inclusion
- Chinese origin, with known or suspected brain or spine diseases
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
147 Patients enrolled
Trial Details
Trial ID
NCT00395460
Start Date
September 1 2006
End Date
April 1 2007
Last Update
June 8 2015
Active Locations (4)
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1
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
2
The 1st Affiliated Hosp of the 4th Military Med Uni
Xi'an, Shaanxi, China, 710032
3
Chinese PLA General Hosp.
Beijing, China, 100853
4
Fudan University Huashan Hospital
Shanghai, China, 200040