check_circleStudy Completed

Liver

Bayer Identifier:

14332

ClinicalTrials.gov Identifier:

NCT00924248

EudraCT Number:

Not Available

EU CT Number:

Not Available
Primovist Regulatory Post Marketing Surveillance (PMS)

Trial purpose

The objective of this Post Marketing Surveillance (PMS) is to gain information about safety and efficacy in real practice

Key Participants Requirements

Sex

Both

Age

0 - N/A


  • - Patient who take Primovist for liver MRI


  • - Patients who belong to the contraindication on the product label

Trial summary

Enrollment Goal
4358
Trial Dates
October 2007 - May 2011
Phase
N/A
Could I Receive a placebo
No
Products
Eovist/Primovist (Gadoxetate disodium, BAY86-4873)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Korea, Republic Of

Primary Outcome

  • Safety evaluation in real practice (SAE/AE/ADR collection)
    date_rangeTime Frame:
    After administration
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Assessment of contrast effect by imaging after administration
    date_rangeTime Frame:
    Before administration
    enhanced_encryption
    Safety Issue:
    No
  • Overall contrast effects by combining individual assessment
    date_rangeTime Frame:
    Before administration
    enhanced_encryption
    Safety Issue:
    No
  • Assessment of contrast enhancement effect
    date_rangeTime Frame:
    After administration
    enhanced_encryption
    Safety Issue:
    No

Trial design

Primovist regulatory Post Marketing Surveillance
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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