Trial Condition(s):

Magnetic Resonance Imaging

Observational study on the safety and tolerability of Gadobutrol (Gadovist) among Filipino patients in Magnetic Resonance Imaging

Bayer Identifier:

13926

ClinicalTrials.gov Identifier:

NCT00905879

EudraCT Number:

Not Available

Study Completed

Trial Purpose

Patients will be recruited from those who will undergo contrast enhanced MRI. Safety and tolerability will be assessed.

Inclusion Criteria
- 18 years old and above undergoing contrast enhanced cranial or spinal MRI with Gadobutrol (Gadovist)
Exclusion Criteria
- History of hypersensitivity reaction to gadolinium containing contrast material 
 - Hypersensitivity to any of the ingredients of Gadobutrol (Gadovist) 
 - History of hypersensitivity to any other contrast agent 
 - Patients with uncorrected hypokalemia 
 - Pregnant and lactating women 
 - Patients with severe cardiovascular diseases 
 - Patients in whom MRI cannot be performed.

Trial Summary

Enrollment Goal
30
Trial Dates
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Phase
N/A
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

Many Locations, Philippines

Status
Completed
 

Trial Design