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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 Magnevist

Incidence 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 extraction

Incidence 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

Click here and search for drug information provided by the FDA.

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.

Starting date: August 2007
Last updated: June 16, 2011

Page last updated: August 23, 2015

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