check_circleStudy Completed
Diagnostic Imaging
Bayer Identifier:
15040
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Primovist post-marketing surveillance in Japan
Trial purpose
This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Primovist for contrast enhancement in MRI of liver. The objective of this study is to assess safety, especially in relation to renal dysfunction, and efficacy of using Primovist in clinical practice. A total 2,000 patients for diagnosis on detection and identify hepatic tumor will be recruited and followed 7 days after the injection.
Key Participants Requirements
Sex
BothAge
0 - N/ATrial summary
Enrollment Goal
2030Trial Dates
March 2008 - February 2015Phase
N/ACould I Receive a placebo
NoProducts
Eovist/Primovist (Gadoxetate disodium, BAY86-4873)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Japan |
Primary Outcome
- Incidence of adverse drug reactions and serious adverse events in subjects who received Primovistdate_rangeTime Frame:After Primovist injection, up to 7 daysenhanced_encryptionYesSafety Issue:
- Incidence of adverse drug reactions in patients with renal impairmentdate_rangeTime Frame:After Primovist injection, up to 7 daysenhanced_encryptionYesSafety Issue:
Secondary Outcome
- Incidence of adverse drug reactions in subpopulation in a variety of baseline data [such as demographic data, concomitant disease and dose of Primovist]date_rangeTime Frame:After Primovist injection, up to 7 daysenhanced_encryptionYesSafety Issue:
- MRI image evaluation assessment by the five rank scales of 1 to 5: 1) much improved; 2) improved; 3) slightly improved; 4) not improved; and 5) impaireddate_rangeTime Frame:After Primovist injection, up to 7 daysenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A