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NCT00905879 Clinical Trial

Observational Study on the Safety and Tolerability of Gadobutrol (Gadovist) Among Filipino Patients in Magnetic Resonance Imaging

Magnetic Resonance Imaging Clinical Trial

Official title:
Observational Study on the Safety and Tolerability of Gadobutrol (Gadovist) Among Filipino Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00905879
Other study ID # 13926
Secondary ID GV0811PH
Status Completed
Phase N/A
First received April 27, 2009
Last updated April 25, 2013
Start date June 2009
Est. completion date January 2011

Study information
Verified date April 2013
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Philippines: Bureau of Food and DrugsPhilippines: Department of Health
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date January 2011
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Gadobutrol (Gadovist, BAY86-4875)
Patients who will need to undergo contrast enhanced MRI with gadobutrol (Gadovist)

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Philippines, 

Outcome
Type Measure Description Time frame Safety issue
Other Magnetic field strength of MRI During the procedure No
Other Volume of contrast agent used During the procedure No
Primary 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 Yes
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