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

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Primovist Regulatory Post Marketing Surveillance

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Safety evaluation in real practice (SAE/AE/ADR collection) [ Time Frame: After administration ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Assessment of contrast effect by imaging after administration [ Time Frame: Before administration ] [ Designated as safety issue: No ]
  • Overall contrast effects by combining individual assessment [ Time Frame: Before administration ] [ Designated as safety issue: No ]
  • Assessment of contrast enhancement effect [ Time Frame: After administration ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained
n.a.

Enrollment: 4358
Study Start Date: October 2007
Study Completion Date: May 2011
Groups/Cohorts Assigned Interventions
Group 1 Drug: Gadoxetic acid disodium (Primovist, BAY86-4873)
Patients in daily life clinical practice treatment receiving Primovist according to indication on the label.

  Eligibility

Ages Eligible for Study:   Child, Adult, Senior
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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 
Study First Received: June 17, 2009
Last Updated: September 18, 2012
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Bayer:
Liver MRI

ClinicalTrials.gov processed this record on September 28, 2016