Primovist Regulatory Post Marketing Surveillance (PMS)

This study has been completed.

Sponsor:

Information provided by:

Bayer

ClinicalTrials.gov Identifier:

NCT00924248

First received: June 17, 2009

Last updated: September 18, 2012

Last verified: September 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

June 17, 2009

Last Updated Date

September 18, 2012

Start Date ^ICMJE

October 2007

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Safety and efficacy evaluation in real practice [ Time Frame: After administration ]

Change History

Complete list of historical versions of study NCT00924248 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Demography [ Time Frame: Before administration ]
Medical History/Background [ Time Frame: Before administration ]
Dose [ Time Frame: At point of administration ]
Concomitant medication [ Time Frame: At point of administration ]
Facility [ Time Frame: At point of administration ]
Diagnosis [ Time Frame: After administration ]
Serious Adverse Event /Adverse Event collection [ Time Frame: At the point of the occurence ]
Overall evaluation [ Time Frame: After administration ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Primovist Regulatory Post Marketing Surveillance (PMS)

Official Title ^ICMJE

Primovist Regulatory Post Marketing Surveillance

Brief Summary

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

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: None Retained

Description:

n.a.

Sampling Method

Non-Probability Sample

Study Population

Korean who take Primovist for liver MRI

Condition ^ICMJE

Liver

Intervention ^ICMJE

Drug: Gadoxetic acid disodium (Primovist, BAY86-4873)

Patients in daily life clinical practice treatment receiving Primovist according to indication on the label.

Study Groups/Cohorts

Group 1

Intervention: Drug: Gadoxetic acid disodium (Primovist, BAY86-4873)

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

4358

Completion Date

May 2011

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patient who take Primovist for liver MRI

Exclusion Criteria:

Patients who belong to the contraindication on the product label

Sex/Gender

Sexes Eligible for Study:

All

Ages

Child, Adult, Senior

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Korea, Republic of

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00924248

Other Study ID Numbers ^ICMJE

14332
PR0810KR ( Other Identifier: company internal )

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

Plan to Share Data

Not Provided

IPD Description

Not Provided

Responsible Party

Medical Director, Bayer Healthcare AG

Study Sponsor ^ICMJE

Bayer

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Bayer Study Director

Bayer

Information Provided By

Bayer

Verification Date

September 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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