Status:
COMPLETED
Efficacy and Safety Study to Evaluate Gadavist (Gadobutrol) as Contrast Agent in Magnetic Resonance Imaging (MRI) of Vascular Diseases in Chinese Patients
Lead Sponsor:
Bayer
Conditions:
Vascular 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 vascular 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
- Known or suspected blood vessel 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 :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2007
Estimated Enrollment :
83 Patients enrolled
Trial Details
Trial ID
NCT00395733
Start Date
October 1 2006
End Date
October 1 2007
Last Update
December 18 2013
Active Locations (3)
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1
Chengdu, Sichuan, China, 610041
2
Beijing, China, 100853
3
Shanghai, China, 200025