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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
  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


Condition Intervention
Magnetic Resonance Imaging
Magnetic Resonance Angiography
 Drug: Gadobutrol (Gadovist, BAY86-4875)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: GARDIAN, Gadovist in Routine Diagnostic Magnetic Resonance Imaging Administration in Non-selected Patients

Resource links provided by NLM:

MedlinePlus related topics: MRI Scans
Drug Information available for: Gadobutrol
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Number of Adverse Event Collection / Calculation of Adverse Event rates in Study population and subgroups [ Time Frame: 1 day ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   None Retained

n.a


Enrollment: 23775
Study Start Date: July 2010
Study Completion Date: April 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Group 1 Drug: Gadobutrol (Gadovist, BAY86-4875)
Patients requiring contrast enhanced MRI using Gadovist. Administration of Gadovist at the discretion of the attending physician.

Detailed Description:

Evaluate the safety and tolerability of Gadovist in patients requiring contrast-enhanced MRI.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Evaluate the safety and tolerability of Gadovist in patients requiring contrast-enhanced MRI.

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01095081

  Hide Study Locations
Locations
Bosnia and Herzegovina
Many Locations, Bosnia and Herzegovina
Canada
Many Locations, Canada
China
Many Locations, China
Czech Republic
Many Locations, Czech Republic
France
Many Locations, France
Germany
Many Locations, Germany
Greece
Many Locations, Greece
Hong Kong
Many Locations, Hong Kong
Hungary
Many Locations, Hungary
Italy
Many Locations, Italy
Kazakhstan
Many Locations, Kazakhstan
Korea, Republic of
Many Locations, Korea, Republic of
Kyrgyzstan
Many Locations, Kyrgyzstan
Poland
Many Locations, Poland
Russian Federation
Many Locations, Russian Federation
South Africa
Many Locations, South Africa
Spain
Many Locations, Spain
Taiwan
Many Locations, Taiwan
Thailand
Many Locations, Thailand
Vietnam
Many Locations, Vietnam
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Affairs Thearapeutic Area Head, Bayer Healthcare AG
ClinicalTrials.gov Identifier: NCT01095081     History of Changes
Other Study ID Numbers: 14823, GV0901
Study First Received: March 17, 2010
Last Updated: April 10, 2013
Health Authority: Hungary: National Institute of Pharmacy
China: Ethics Committee
South Korea: Korea Food and Drug Administration (KFDA)
South Africa: Human Research Ethics Committee
Russia: Federal Service on Survailance in Healthcare and Social Development
Kazakhstan: Ethical Commission
Kyrgyzstan: Ethical Commission
Taiwan: Institutional Review Board
Thailand: Ethical Committee
France: French Data Protection Authority
Italy: Ethics Committee
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Spain: Regional Health Authorities
Bosnia: Federal Ministry of Health

ClinicalTrials.gov processed this record on June 18, 2013