check_circleStudy Completed

Diagnostic Imaging

Bayer Identifier:

15035

ClinicalTrials.gov Identifier:

NCT01376739

EudraCT Number:

Not Available

EU CT Number:

Not Available
Magnevist post-marketing surveillance in Japan

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.

Key Participants Requirements

Sex

Both

Age

NaN - N/A
  • - 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
  • - Patients who are contraindicated based on the product label

Trial summary

Enrollment Goal
2051
Trial Dates
August 2007 - June 2010
Phase
N/A
Could I Receive a placebo
No
Products
Magnevist (Gadopentetate Dimeglumine, BAY86-4882)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Japan

Primary Outcome

  • Incidence of adverse drug reactions and serious adverse events in subjects who received Magnevist
    date_rangeTime Frame:
    After Magnevist administration, up to 3 years
    enhanced_encryption
    Safety Issue:
    Yes
  • Incidence of adverse drug reactions, especially Nephrogenic Systemic Fibrosis and Nephrogenic Fibrosing Dermopathy (NSF/NFD) in patients with reduced renal functions
    date_rangeTime Frame:
    After Magnevist administration, up to 3 years
    enhanced_encryption
    Safety Issue:
    Yes

Secondary Outcome

  • MRI image evaluation assessment by the four rank scales of 1 to 4: 1) sufficient extraction; 2) almost sufficient extraction; 3) not sufficient extraction; and 4) insufficient extraction
    date_rangeTime Frame:
    After Magnevist injection, up to 3 years
    enhanced_encryption
    Safety Issue:
    No
  • Incidence of adverse drug reactions in subpopulation with baseline data
    date_rangeTime Frame:
    At baseline and after Magnevist administration, up to 3 years
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Drug use investigation of Magnevist
Trial Type
Observational
Intervention Type
Drug
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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