check_circleStudy Completed

Magnetic Resonance Imaging, Image Enhancement

Bayer Identifier:
17512
ClinicalTrials.gov Identifier:
NCT02540967
EudraCT Number:
Not Available
EU CT Number:
Not Available
Drug Use Investigation of Gadovist.

Trial purpose

The objectives of this study are to investigate the safety and effectiveness of Gadovist.

Key Participants Requirements

Sex

Both

Age

NaN - N/A
  • - Patients who perform contrast enhanced Magnetic Resonance Imaging (MRI) with Gadovist.

  • - Patients who are contraindicated based on approved label.

Trial summary

Enrollment Goal
3357
Trial Dates
October 2015 - November 2017
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 LocationsMany Locations, Japan

Primary Outcome

  • Number of episodes of adverse events as a measure of safety and tolerability
    date_rangeTime Frame:
    Up to 3 days
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Number of episodes of adverse drug reactions and adverse events
    In subpopulations
    date_rangeTime Frame:
    Up to 3 days
    enhanced_encryption
    Safety Issue:
    Yes
  • Contrast enhancement
    Investigator Discretion as very improved , improved, not changed, degraded, not evaluable. MRI- Magnetic Resonance Imaging
    date_rangeTime Frame:
    At the time of MRI
    enhanced_encryption
    Safety Issue:
    No

Trial design

Drug Use Investigation of Gadovist
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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