Magnevist Post-marketing Surveillance in Japan
Information source: Bayer
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diagnostic Imaging
Intervention: Gadopentetate dimeglumine (Magnevist, BAY86-4882) (Drug)
Phase: N/A
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
Summary
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.
Clinical Details
Official title: Drug Use Investigation of Magnevist
Study design: Observational Model: Case-Only, Time Perspective: Prospective
Primary outcome: Incidence of adverse drug reactions and serious adverse events in subjects who received MagnevistIncidence of adverse drug reactions, especially Nephrogenic Systemic Fibrosis and Nephrogenic Fibrosing Dermopathy (NSF/NFD) in patients with reduced renal functions
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 extractionIncidence of adverse drug reactions in subpopulation with baseline data
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients who received a dose of more than 0. 2 mg/kg of Magnevist for MR angiography
of peripheral vasculature with continuous imaging from the abdomen to the lower
extremities
Exclusion Criteria:
- Patients who are contraindicated based on the product label
Locations and Contacts
Many Locations, Japan
Additional Information
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Starting date: August 2007
Last updated: June 16, 2011
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