check_circleStudy Completed

Magnetic Resonance Imaging

Bayer Identifier:

13926

ClinicalTrials.gov Identifier:

NCT00905879

EudraCT Number:

Not Available

EU CT Number:

Not Available
Observational study on the safety and tolerability of Gadobutrol (Gadovist) among Filipino patients in Magnetic Resonance Imaging

Trial purpose

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

Key Participants Requirements

Sex

Both

Age

18 - N/A


  • - 18 years old and above undergoing contrast enhanced cranial or spinal MRI with Gadobutrol (Gadovist)


  • - 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
June 2009 - January 2011
Phase
N/A
Could I Receive a placebo
No
Products
Gadavist/Gadovist (Gadobutrol, BAY86-4875)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Philippines

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 events
    date_rangeTime Frame:
    Up to 1 hour after MRI
    enhanced_encryption
    Safety Issue:
    Yes

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
N/A

Additional Information

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