NCT01376739

Magnevist Post-marketing Surveillance in Japan

Drug Use Investigation of Magnevist

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 2,051 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Diagnostic Imaging

Interventions

Type	Name	Description
DRUG	Gadopentetate dimeglumine (Magnevist, BAY86-4882)	Patients who will need to undergo contrast enhanced MR angiography with Magnevist (a dosage of more than 0.2 mg/kg)

Timeline

• Start date: 2007-08-01
• Primary completion: 2010-06-01
• Completion: 2010-06-01
• First posted: 2011-06-20
• Last updated: 2011-06-20

Locations

1 site across 1 country: Japan