Magnevist Post-marketing Surveillance in Japan

Bayer

Status: Completed

Conditions: Diagnostic Imaging

Treatments: Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Study type: Observational

Funder types: Industry

Identifiers

NCT01376739

15035

MAGNEVIST

Details and patient eligibility

About

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.

Enrollment: 2,051 patients

Sex: All

Volunteers: No Healthy Volunteers

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 design

2,051 participants in 1 patient group

Group 1

Treatment:

Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)