Magnevist Post-marketing Surveillance in Japan

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

2051 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-08-31

Study Completion Date

2010-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Diagnostic Imaging

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Group 1

Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Intervention Type DRUG

Patients who will need to undergo contrast enhanced MR angiography with Magnevist (a dosage of more than 0.2 mg/kg)

Interventions

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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)

Intervention Type DRUG

Eligibility Criteria

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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