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Magnevist Post-marketing Surveillance in Japan

NCT01376739 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 2051

Last updated 2011-06-20

No results posted yet for this study

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

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)

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2010-06-30
Completion
2010-06-30

Countries

  • Japan

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01376739 on ClinicalTrials.gov