Observational Study on the Safety and Tolerability of Gadobutrol (Gadovist) Among Filipino Patients in Magnetic Resonance Imaging
- Registration Number
- NCT00905879
- Lead Sponsor
- Bayer
- Brief Summary
Patients will be recruited from those who will undergo contrast enhanced MRI. Safety and tolerability will be assessed.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
Inclusion Criteria
- 18 years old and above undergoing contrast enhanced cranial or spinal MRI with Gadobutrol (Gadovist)
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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.
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Gadobutrol (Gadovist, BAY86-4875) -
- Primary Outcome Measures
Name Time Method The primary outcome measures would be safety and tolerability of Gadovist which would be measured by change in Vital signs before and after the procedure and the occurrence of serious or non-serious adverse events Up to 1 hour after MRI
- Secondary Outcome Measures
Name Time Method