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Primovist Regulatory Post Marketing Surveillance (PMS)

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ClinicalTrials.gov Identifier: NCT00924248
Recruitment Status : Completed
First Posted : June 18, 2009
Last Update Posted : September 19, 2012
Sponsor:
Information provided by:

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

Condition or disease Intervention/treatment
Liver Drug: Gadoxetic acid disodium (Primovist, BAY86-4873)

Study Design

Study Type : Observational
Actual Enrollment : 4358 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Primovist Regulatory Post Marketing Surveillance
Study Start Date : October 2007
Study Completion Date : May 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

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.


Outcome Measures

Primary Outcome Measures :
  1. Safety evaluation in real practice (SAE/AE/ADR collection) [ Time Frame: After administration ]

Secondary Outcome Measures :
  1. Assessment of contrast effect by imaging after administration [ Time Frame: Before administration ]
  2. Overall contrast effects by combining individual assessment [ Time Frame: Before administration ]
  3. Assessment of contrast enhancement effect [ Time Frame: After administration ]

Biospecimen Retention:   None Retained
n.a.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Korean who take Primovist for liver MRI
Criteria

Inclusion Criteria:

  • Patient who take Primovist for liver MRI

Exclusion Criteria:

  • Patients who belong to the contraindication on the product label
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00924248


Locations
Korea, Republic of
Many Locations, Korea, Republic of
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
More Information

Additional Information:
Responsible Party: Medical Director, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT00924248     History of Changes
Other Study ID Numbers: 14332
PR0810KR ( Other Identifier: company internal )
First Posted: June 18, 2009    Key Record Dates
Last Update Posted: September 19, 2012
Last Verified: September 2012

Keywords provided by Bayer:
Liver MRI