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

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ClinicalTrials.gov Identifier: NCT01095081
Recruitment Status : Completed
First Posted : March 29, 2010
Last Update Posted : January 21, 2015
Sponsor:
Information provided by (Responsible Party):
Bayer

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

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

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

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Study Type : Observational
Actual Enrollment : 23775 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: GARDIAN, Gadovist in Routine Diagnostic Magnetic Resonance Imaging Administration in Non-selected Patients
Study Start Date : July 2010
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Gadobutrol

Group/Cohort Intervention/treatment
Group 1 Drug: Gadobutrol (Gadovist, BAY86-4875)
Patients requiring contrast enhanced MRI using Gadovist. Administration of Gadovist at the discretion of the attending physician.




Primary Outcome Measures :
  1. Number of Adverse Event Collection / Calculation of Adverse Event rates in Study population and subgroups [ Time Frame: 1 day ]

Secondary Outcome Measures :
  1. Analysis of Adverse Event Collection rates according to age, gender, concomitant diseases and risk factors, dose administered. [ Time Frame: 1 day ]

Biospecimen Retention:   None Retained
n.a


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01095081


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Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01095081     History of Changes
Other Study ID Numbers: 14823
GV0901 ( Other Identifier: company internal )
First Posted: March 29, 2010    Key Record Dates
Last Update Posted: January 21, 2015
Last Verified: January 2015