check_circleStudy Completed

Diagnostic Imaging

Bayer Identifier:

15040

ClinicalTrials.gov Identifier:

NCT01411449

EudraCT Number:

Not Available

EU CT Number:

Not Available
Primovist post-marketing surveillance in Japan

Trial purpose

This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Primovist for contrast enhancement in MRI of liver. The objective of this study is to assess safety, especially in relation to renal dysfunction, and efficacy of using Primovist in clinical practice. A total 2,000 patients for diagnosis on detection and identify hepatic tumor will be recruited and followed 7 days after the injection.

Key Participants Requirements

Sex

Both

Age

0 - N/A
  • - Patients who received Primovist for liver MRI

  • - Patients who are contraindicated based on the product label

Trial summary

Enrollment Goal
2030
Trial Dates
March 2008 - February 2015
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, Japan

Primary Outcome

  • Incidence of adverse drug reactions and serious adverse events in subjects who received Primovist
    date_rangeTime Frame:
    After Primovist injection, up to 7 days
    enhanced_encryption
    Safety Issue:
    Yes
  • Incidence of adverse drug reactions in patients with renal impairment
    date_rangeTime Frame:
    After Primovist injection, up to 7 days
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, concomitant disease and dose of Primovist]
    date_rangeTime Frame:
    After Primovist injection, up to 7 days
    enhanced_encryption
    Safety Issue:
    Yes
  • MRI image evaluation assessment by the five rank scales of 1 to 5: 1) much improved; 2) improved; 3) slightly improved; 4) not improved; and 5) impaired
    date_rangeTime Frame:
    After Primovist injection, up to 7 days
    enhanced_encryption
    Safety Issue:
    No

Trial design

Drug use investigation of EOB-Primovist inj. Syringe
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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