GARDIAN, Gadovist in Routine Diagnostic Magnetic Resonance Imaging Administration in Non-selected Patients
GARDIAN
2 other identifiers
observational
23,775
20 countries
20
Brief Summary
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2010
Typical duration for all trials
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 17, 2010
CompletedFirst Posted
Study publicly available on registry
March 29, 2010
CompletedStudy Start
First participant enrolled
July 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2013
CompletedJanuary 21, 2015
January 1, 2015
2.8 years
March 17, 2010
January 19, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Adverse Event Collection / Calculation of Adverse Event rates in Study population and subgroups
1 day
Secondary Outcomes (1)
Analysis of Adverse Event Collection rates according to age, gender, concomitant diseases and risk factors, dose administered.
1 day
Study Arms (1)
Group 1
Interventions
Patients requiring contrast enhanced MRI using Gadovist. Administration of Gadovist at the discretion of the attending physician.
Eligibility Criteria
Evaluate the safety and tolerability of Gadovist in patients requiring contrast-enhanced MRI.
You may qualify if:
- Patients undergoing contrast enhanced Magnetic Resonance Imaging with Gadobutrol (Gadovist).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Bayerlead
Study Sites (20)
Unknown Facility
Many Locations, Bosnia and Herzegovina
Unknown Facility
Many Locations, Canada
Unknown Facility
Many Locations, China
Unknown Facility
Many Locations, Czechia
Unknown Facility
Many Locations, France
Unknown Facility
Many Locations, Germany
Unknown Facility
Many Locations, Greece
Unknown Facility
Many Locations, Hong Kong
Unknown Facility
Many Locations, Hungary
Unknown Facility
Many Locations, Italy
Unknown Facility
Many Locations, Kazakhstan
Unknown Facility
Many Locations, Kyrgyzstan
Unknown Facility
Many Locations, Poland
Unknown Facility
Many Locations, Russia
Unknown Facility
Many Locations, South Africa
Unknown Facility
Many Locations, South Korea
Unknown Facility
Many Locations, Spain
Unknown Facility
Many Locations, Taiwan
Unknown Facility
Many Locations, Thailand
Unknown Facility
Many Locations, Vietnam
MeSH Terms
Interventions
Study Officials
- STUDY DIRECTOR
Bayer Study Director
Bayer
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2010
First Posted
March 29, 2010
Study Start
July 1, 2010
Primary Completion
April 1, 2013
Study Completion
April 1, 2013
Last Updated
January 21, 2015
Record last verified: 2015-01