Primovist Regulatory Post Marketing Surveillance (PMS)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT00924248 |
Recruitment Status
:
Completed
First Posted
: June 18, 2009
Last Update Posted
: September 19, 2012
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Sponsor:
Bayer
Information provided by:
Bayer
Tracking Information | ||||
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First Submitted Date | June 17, 2009 | |||
First Posted Date | June 18, 2009 | |||
Last Update Posted Date | September 19, 2012 | |||
Study Start Date | October 2007 | |||
Primary Completion Date | Not Provided | |||
Current Primary Outcome Measures |
Safety evaluation in real practice (SAE/AE/ADR collection) [ Time Frame: After administration ] | |||
Original Primary Outcome Measures |
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 |
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Original Secondary Outcome Measures |
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Current Other Outcome Measures | Not Provided | |||
Original Other Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Primovist Regulatory Post Marketing Surveillance (PMS) | |||
Official Title | 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 | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Retention: None Retained Description: n.a. |
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Sampling Method | Non-Probability Sample | |||
Study Population | Korean who take Primovist for liver MRI | |||
Condition | Liver | |||
Intervention | Drug: Gadoxetic acid disodium (Primovist, BAY86-4873)
Patients in daily life clinical practice treatment receiving Primovist according to indication on the label. |
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Study Groups/Cohorts | Group 1
Intervention: Drug: Gadoxetic acid disodium (Primovist, BAY86-4873) |
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Completed | |||
Actual Enrollment |
4358 | |||
Original Estimated Enrollment |
4500 | |||
Actual Study Completion Date | May 2011 | |||
Primary Completion Date | Not Provided | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | Child, Adult, Senior | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Korea, Republic of | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00924248 | |||
Other Study ID Numbers | 14332 PR0810KR ( Other Identifier: company internal ) |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Medical Director, Bayer Healthcare AG | |||
Study Sponsor | Bayer | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Bayer | |||
Verification Date | September 2012 |