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NCT00924248 Clinical Trial

Primovist Regulatory Post Marketing Surveillance (PMS)

Liver Clinical Trial

Official title:
Primovist Regulatory Post Marketing Surveillance

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00924248
Other study ID # 14332
Secondary ID PR0810KR
Status Completed
Phase N/A
First received June 17, 2009
Last updated September 18, 2012
Start date October 2007
Est. completion date May 2011

Study information
Verified date September 2012
Source Bayer
Contact n/a
Is FDA regulated No
Health authority South Korea: Korea Food and Drug Administration (KFDA)
Study type Observational

Clinical Trial Summary

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

Recruitment information / eligibility
Status Completed
Enrollment 4358
Est. completion date May 2011
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Patient who take Primovist for liver MRI

Exclusion Criteria:

- Patients who belong to the contraindication on the product label

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Gadoxetic acid disodium (Primovist, BAY86-4873)
Patients in daily life clinical practice treatment receiving Primovist according to indication on the label.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Safety evaluation in real practice (SAE/AE/ADR collection) After administration Yes
Secondary Assessment of contrast effect by imaging after administration Before administration No
Secondary Overall contrast effects by combining individual assessment Before administration No
Secondary Assessment of contrast enhancement effect After administration No
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