Trial Condition(s):

Magnetic Resonance Imaging, Magnetic Resonance Angiography

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

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
black-arrow
Phase
N/A
Could I receive a placebo?
No
Products
Gadavist/Gadovist (Gadobutrol, BAY86-4875)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Investigative Site

Many Locations, Taiwan, China

Status
Completed
 
Locations

Investigative Site

Many Locations, Poland

Status
Completed
 
Locations

Investigative Site

Many Locations, South Africa

Status
Completed
 
Locations

Investigative Site

Many Locations, Italy

Status
Completed
 
Locations

Investigative Site

Many Locations, Hungary

Status
Completed
 
Locations

Investigative Site

Many Locations, Kazakhstan

Status
Completed
 
Locations

Investigative Site

Many Locations, South Korea

Status
Completed
 
Locations

Investigative Site

Many Locations, Hong Kong, China

Status
Completed
 
Locations

Investigative Site

Many Locations, Russia

Status
Completed
 
Locations

Investigative Site

Many Locations, China

Status
Completed
 
Locations

Investigative Site

Many Locations, Thailand

Status
Completed
 
Locations

Investigative Site

Many Locations, Bosnia and Herzegovina

Status
Completed
 
Locations

Investigative Site

Many Locations, France

Status
Completed
 
Locations

Investigative Site

Many Locations, Greece

Status
Completed
 
Locations

Investigative Site

Many Locations, Vietnam

Status
Completed
 
Locations

Investigative Site

Many Locations, Czech Republic

Status
Completed
 
Locations

Investigative Site

Many Locations, Spain

Status
Completed
 
Locations

Investigative Site

Many Locations, Canada

Status
Completed
 
Locations

Investigative Site

Many Locations, Germany

Status
Completed
 
Locations

Investigative Site

Many Locations, Kyrgyzstan

Status
Completed
 

Trial Design