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Magnevist Post-marketing Surveillance in Japan

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01376739
First Posted: June 20, 2011
Last Update Posted: June 20, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bayer
  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.

Condition Intervention
Diagnostic Imaging Drug: Gadopentetate dimeglumine (Magnevist, BAY86-4882)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Drug Use Investigation of Magnevist

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Incidence of adverse drug reactions and serious adverse events in subjects who received Magnevist [ Time Frame: After Magnevist administration, up to 3 years ]
  • Incidence of adverse drug reactions, especially Nephrogenic Systemic Fibrosis and Nephrogenic Fibrosing Dermopathy (NSF/NFD) in patients with reduced renal functions [ Time Frame: After Magnevist administration, up to 3 years ]

Secondary Outcome Measures:
  • 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 [ Time Frame: After Magnevist injection, up to 3 years ]
  • Incidence of adverse drug reactions in subpopulation with baseline data [ Time Frame: At baseline and after Magnevist administration, up to 3 years ]

Enrollment: 2051
Study Start Date: August 2007
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 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)

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The target population of this study is patients who received Magnevist for MR angiography. The study is expected to collect data of 2,000 patients in approximately 150 hospitals in Japan.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01376739


Locations
Japan
Many Locations, Japan
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Responsible Party: Head Medical Development Japan, Bayer Yakuhin Co. LTD.
ClinicalTrials.gov Identifier: NCT01376739     History of Changes
Other Study ID Numbers: 15035
MAGNEVIST
First Submitted: June 8, 2011
First Posted: June 20, 2011
Last Update Posted: June 20, 2011
Last Verified: June 2011

Keywords provided by Bayer:
Magnevist
MR angiography