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GARDIAN, Gadovist in Routine Diagnostic Magnetic Resonance Imaging Administration in Non-selected Patients

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01095081
First received: March 17, 2010
Last updated: April 10, 2013
Last verified: April 2013
History of Changes

March 17, 2010
April 10, 2013
July 2010
April 2013   (final data collection date for primary outcome measure)
Number of Adverse Event Collection / Calculation of Adverse Event rates in Study population and subgroups [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01095081 on ClinicalTrials.gov Archive Site
Analysis of Adverse Event Collection rates according to age, gender, concomitant diseases and risk factors, dose administered. [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
GARDIAN, Gadovist in Routine Diagnostic Magnetic Resonance Imaging Administration in Non-selected Patients
GARDIAN, Gadovist in Routine Diagnostic Magnetic Resonance Imaging Administration in Non-selected Patients

Prospective, non-interventional, multi-center study. The observation period for each subject covers the treatment period with Gadovist®. For each patient, the treating physician or nurse documents demographics, medical data, safety parameters and treatment signs and symptoms at the visit. Patients with severe renal impairment will be followed-up after 3 month by phone call from the investigator if in line with routine practice. Data audit/monitoring by source data verification will be done in a subset of sites and patients

Evaluate the safety and tolerability of Gadovist in patients requiring contrast-enhanced MRI.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   None Retained
Description:

n.a
Non-Probability Sample

Evaluate the safety and tolerability of Gadovist in patients requiring contrast-enhanced MRI.
  • Magnetic Resonance Imaging
  • Magnetic Resonance Angiography
Drug: Gadobutrol (Gadovist, BAY86-4875)
Patients requiring contrast enhanced MRI using Gadovist. Administration of Gadovist at the discretion of the attending physician.
Group 1
Intervention: Drug: Gadobutrol (Gadovist, BAY86-4875)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23775
April 2013
April 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Patients undergoing contrast enhanced Magnetic Resonance Imaging with Gadobutrol (Gadovist).

Exclusion Criteria:

  • There are no other exclusion criteria beyond the contraindications contained in the Summary of Product Characteristics (hypersensitivity to the active substance or to any of the excipients) and the warnings.
Both
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Bosnia and Herzegovina,   Canada,   China,   Czech Republic,   France,   Germany,   Greece,   Hong Kong,   Hungary,   Italy,   Kazakhstan,   Korea, Republic of,   Kyrgyzstan,   Poland,   Russian Federation,   South Africa,   Spain,   Taiwan,   Thailand,   Vietnam
 
NCT01095081
14823, GV0901
No
Medical Affairs Thearapeutic Area Head, Bayer Healthcare AG
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP