NCT01095081

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 23,775 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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

Detailed description

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

Conditions

• Magnetic Resonance Imaging
• Magnetic Resonance Angiography

Interventions

Type	Name	Description
DRUG	Gadobutrol (Gadovist, BAY86-4875)	Patients requiring contrast enhanced MRI using Gadovist. Administration of Gadovist at the discretion of the attending physician.

Timeline

• Start date: 2010-07-01
• Primary completion: 2013-04-01
• Completion: 2013-04-01
• First posted: 2010-03-29
• Last updated: 2015-01-21

Locations

20 sites across 20 countries: Bosnia and Herzegovina, Canada, China, Czechia, France, Germany, Greece, Hong Kong, Hungary, Italy, Kazakhstan, Kyrgyzstan, Poland, Russia, South Africa, South Korea, Spain, Taiwan, Thailand, Vietnam