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:
EudraCT Number:
Not Available
EU CT 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
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
| Locations | |
|---|---|
Locations Investigative Site Many Locations, Philippines | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
Observational study on the safety and tolerability of Gadobutrol (Gadovist) among Filipino patients
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- 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 eventsTimeframe: Up to 1 hour after MRI
Additional Information
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