check_circleStudy Completed
Diagnostic Imaging
Bayer Identifier:
15035
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Magnevist 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 Magnevist at a dose of more than 0.2 ml/kg for MR angiography of peripheral vasculature with continuous imaging from the abdomen to the lower extremities. The objective of this study is to assess safety, especially in relation to renal dysfunction, and efficacy of using Magnevist in clinical practice. A total 2,000 patients will be recruited.
Key Participants Requirements
Sex
BothAge
NaN - N/ATrial summary
Enrollment Goal
2051Trial Dates
August 2007 - June 2010Phase
N/ACould I Receive a placebo
NoProducts
Magnevist (Gadopentetate Dimeglumine, BAY86-4882)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 Magnevistdate_rangeTime Frame:After Magnevist administration, up to 3 yearsenhanced_encryptionYesSafety Issue:
- Incidence of adverse drug reactions, especially Nephrogenic Systemic Fibrosis and Nephrogenic Fibrosing Dermopathy (NSF/NFD) in patients with reduced renal functionsdate_rangeTime Frame:After Magnevist administration, up to 3 yearsenhanced_encryptionYesSafety Issue:
Secondary Outcome
- MRI image evaluation assessment by the four rank scales of 1 to 4: 1) sufficient extraction; 2) almost sufficient extraction; 3) not sufficient extraction; and 4) insufficient extractiondate_rangeTime Frame:After Magnevist injection, up to 3 yearsenhanced_encryptionNoSafety Issue:
- Incidence of adverse drug reactions in subpopulation with baseline datadate_rangeTime Frame:At baseline and after Magnevist administration, up to 3 yearsenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A