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NCT01095081 Clinical Trial

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

Magnetic Resonance Imaging Clinical Trial

— GARDIAN  

Official title:
GARDIAN, Gadovist in Routine Diagnostic Magnetic Resonance Imaging Administration in Non-selected Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01095081
Other study ID # 14823
Secondary ID GV0901
Status Completed
Phase N/A
First received March 17, 2010
Last updated January 19, 2015
Start date July 2010
Est. completion date April 2013

Study information
Verified date January 2015
Source Bayer
Contact n/a
Is FDA regulated No
Health authority Hungary: National Institute of PharmacyChina: Ethics CommitteeSouth Korea: Korea Food and Drug Administration (KFDA)South Africa: Human Research Ethics CommitteeRussia: Federal Service on Survailance in Healthcare and Social DevelopmentKazakhstan: Ethical CommissionKyrgyzstan: Ethical CommissionTaiwan: Institutional Review BoardThailand: Ethical CommitteeFrance: French Data Protection AuthorityItaly: Ethics CommitteePoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSpain: Regional Health AuthoritiesBosnia: Federal Ministry of Health
Study type Observational

Clinical Trial 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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 23775
Est. completion date April 2013
Est. primary completion date April 2013
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Gadobutrol (Gadovist, BAY86-4875)
Patients requiring contrast enhanced MRI using Gadovist. Administration of Gadovist at the discretion of the attending physician.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Bayer

Countries where clinical trial is conducted

Bosnia and Herzegovina,  Canada,  China,  Czech Republic,  France,  Germany,  Greece,  Hong Kong,  Hungary,  Italy,  Kazakhstan,  Korea, Republic of,  Kyrgyzstan,  Poland,  Russian Federation,  South Africa,  Spain,  Taiwan,  Thailand,  Vietnam, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Adverse Event Collection / Calculation of Adverse Event rates in Study population and subgroups 1 day Yes
Secondary Analysis of Adverse Event Collection rates according to age, gender, concomitant diseases and risk factors, dose administered. 1 day Yes
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