check_circleStudy Completed

Epidemiologic factors

Bayer Identifier:

14317

ClinicalTrials.gov Identifier:

NCT00874640

EudraCT Number:

Not Available

EU CT Number:

Not Available
Patient characteristics in daily radiological practice of Gadovist® application (PATRON)

Trial purpose

To evaluate patient characteristics in the current daily radiological practice of Gadovist application. Special focus will be laid on the individual risk factors of patients, the indications for and the dose of Gadovist application.

Secondary objective is to prove the known safety profile (especially rare adverse events) of Gadovist and to collect data on handling problems with different application forms (one questionnaire per center).

Key Participants Requirements

Sex

Both

Age

7 - N/A


  • - patients with indication for a MRT or MR-Angiography and for whom the radiologist has decided to use the contrast medium Gadovist


  • - No exclusion criteria besides the contraindications for the use of Gadovist as mentioned in the German product information.

Trial summary

Enrollment Goal
3711
Trial Dates
March 2009 - November 2011
Phase
N/A
Could I Receive a placebo
No
Products
Gadavist/Gadovist (Gadobutrol, BAY86-4875)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many Locations, Germany

Primary Outcome

  • Patient Profile
    date_rangeTime Frame:
    At day of application
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Dosing of Gadovist in different indications
    date_rangeTime Frame:
    At time of application
    enhanced_encryption
    Safety Issue:
    No
  • Adverse Events
    date_rangeTime Frame:
    Throughout and after application
    enhanced_encryption
    Safety Issue:
    Yes

Trial design

Patient characteristics in daily radiological practice of Gadovist® application (PATRON)
Trial Type
Observational
Intervention Type
Biological/Vaccine
Trial Purpose
N/A
Allocation
N/A
Blinding
N/A
Assignment
N/A
Trial Arms
N/A

Additional Information

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