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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00905879
First Posted: May 21, 2009
Last Update Posted: April 26, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bayer
  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 ]

Other Outcome Measures:
  • Magnetic field strength of MRI [ Time Frame: During the procedure ]
  • Volume of contrast agent used [ Time Frame: During the procedure ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00905879


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

Additional Information:
Responsible Party: Medical Director, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00905879     History of Changes
Other Study ID Numbers: 13926
GV0811PH ( Other Identifier: Company Internal )
First Submitted: April 27, 2009
First Posted: May 21, 2009
Last Update Posted: April 26, 2013
Last Verified: April 2013

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