Trial Condition(s):

Diagnostic Imaging

Magnevist post-marketing surveillance in Japan

Bayer Identifier:

15035

ClinicalTrials.gov Identifier:

NCT01376739

EudraCT Number:

Not Available

Study Completed

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.

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

Trial Summary

Enrollment Goal
2051
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Magnevist (Gadopentetate Dimeglumine, BAY86-4882)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Japan

Status
Completed
 

Trial Design