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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00905879
First received: April 27, 2009
Last updated: April 25, 2013
Last verified: April 2013
  Purpose

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


Condition Intervention
Magnetic Resonance Imaging
Drug: Gadobutrol (Gadovist, BAY86-4875)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Observational Study on the Safety and Tolerability of Gadobutrol (Gadovist) Among Filipino Patients

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 [ Time Frame: Up to 1 hour after MRI ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Magnetic field strength of MRI [ Time Frame: During the procedure ] [ Designated as safety issue: No ]
  • Volume of contrast agent used [ Time Frame: During the procedure ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

n.a.


Enrollment: 30
Study Start Date: June 2009
Study Completion Date: January 2011
Groups/Cohorts Assigned Interventions
Group 1 Drug: Gadobutrol (Gadovist, BAY86-4875)
Patients who will need to undergo contrast enhanced MRI with gadobutrol (Gadovist)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients 18 years old and above who will undergo contrast enhanced MRI with Gadobutrol (Gadovist)

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00905879

Locations
Philippines
Many Locations, Philippines
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided

Responsible Party: Medical Director, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00905879     History of Changes
Other Study ID Numbers: 13926, GV0811PH
Study First Received: April 27, 2009
Last Updated: April 25, 2013
Health Authority: Philippines: Bureau of Food and Drugs
Philippines: Department of Health

Keywords provided by Bayer:
Magnetic Resonance Imaging (MRI)
Observational study
Gadobutrol

ClinicalTrials.gov processed this record on April 23, 2014