Trial Condition(s):

Magnetic Resonance Imaging

GARDIAN, Gadovist in Routine Diagnostic Magnetic Resonance Imaging Administration in Non-selected patients (GARDIAN)

Bayer Identifier:

14823

ClinicalTrials.gov Identifier:

NCT01095081

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study Completed

Trial Purpose

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

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.

Trial Summary

Enrollment Goal
23775
Trial Dates
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Phase
N/A
Could I receive a placebo?
No
Products
Gadavist/Gadovist (Gadobutrol, BAY86-4875)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
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Investigative Site

Many Locations, Taiwan, China

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Investigative Site

Many Locations, Poland

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Many Locations, South Africa

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Many Locations, Italy

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Many Locations, Hungary

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Many Locations, Kazakhstan

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Many Locations, South Korea

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Many Locations, Hong Kong, China

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Many Locations, Russia

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Many Locations, China

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Many Locations, Thailand

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Many Locations, Bosnia and Herzegovina

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Many Locations, France

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Many Locations, Greece

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Many Locations, Vietnam

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Many Locations, Czech Republic

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Many Locations, Spain

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Many Locations, Canada

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Many Locations, Germany

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Investigative Site

Many Locations, Kyrgyzstan

Trial Design