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

NCT01095081 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 23775

Last updated 2015-01-21

No results posted yet for this study

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

Conditions

  • Magnetic Resonance Imaging
  • Magnetic Resonance Angiography

Interventions

DRUG

Gadobutrol (Gadovist, BAY86-4875)

Patients requiring contrast enhanced MRI using Gadovist. Administration of Gadovist at the discretion of the attending physician.

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2013-04-30
Completion
2013-04-30

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

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01095081 on ClinicalTrials.gov