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

Overview

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

Full Title of Study: “Observational Study on the Safety and Tolerability of Gadobutrol (Gadovist) Among Filipino Patients”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective

Interventions

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

Arms, Groups and Cohorts

  • Group 1

Clinical Trial Outcome Measures

Primary 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Bayer
  • Provider of Information About this Clinical Study
    • Medical Director, Bayer HealthCare AG
  • Overall Official(s)
    • Bayer Study Director, Study Director, Bayer

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