Primovist Regulatory Post Marketing Surveillance (PMS)

September 18, 2012 updated by: Bayer

Primovist Regulatory Post Marketing Surveillance

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

4358

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Korean who take Primovist for liver MRI

Description

Inclusion Criteria:

  • Patient who take Primovist for liver MRI

Exclusion Criteria:

  • Patients who belong to the contraindication on the product label

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Group 1
Drug: Gadoxetic acid disodium (Primovist, BAY86-4873)
Patients in daily life clinical practice treatment receiving Primovist according to indication on the label.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Safety evaluation in real practice (SAE/AE/ADR collection)
Time Frame: After administration
After administration

Secondary Outcome Measures

Outcome Measure
Time Frame
Assessment of contrast effect by imaging after administration
Time Frame: Before administration
Before administration
Overall contrast effects by combining individual assessment
Time Frame: Before administration
Before administration
Assessment of contrast enhancement effect
Time Frame: After administration
After administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2007

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

June 17, 2009

First Submitted That Met QC Criteria

June 17, 2009

First Posted (Estimate)

June 18, 2009

Study Record Updates

Last Update Posted (Estimate)

September 19, 2012

Last Update Submitted That Met QC Criteria

September 18, 2012

Last Verified

September 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 14332
  • PR0810KR (Other Identifier: company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Locations

3
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