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Patient Characteristics in Daily Radiological Practice of Gadovist® Application (PATRON)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00874640
First received: March 31, 2009
Last updated: February 19, 2014
Last verified: February 2014

March 31, 2009
February 19, 2014
March 2009
September 2011   (final data collection date for primary outcome measure)
Patient Profile [ Time Frame: At day of application ] [ Designated as safety issue: No ]
Patient Profile [ Time Frame: At day of application ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00874640 on ClinicalTrials.gov Archive Site
  • Dosing of Gadovist in different indications [ Time Frame: At time of application ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: Throughout and after application ] [ Designated as safety issue: Yes ]
  • Dosing of Gadovist in different indications [ Time Frame: At time of application ] [ Designated as safety issue: No ]
  • Adverse Events [ Time Frame: Throughout and after application ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
Patient Characteristics in Daily Radiological Practice of Gadovist® Application (PATRON)
Patient Characteristics in Daily Radiological Practice of Gadovist® Application (PATRON)

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).

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

Radiological practice

Epidemiologic Factors
Biological: Gadobutrol (Gadovist, BAY86-4875)
Patients with indication for a MRT or MR-Angiography and for whom the radiologist has decided to use the contrast medium gadobutrol
Group 1
Intervention: Biological: Gadobutrol (Gadovist, BAY86-4875)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
3711
November 2011
September 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

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

Exclusion Criteria:

  • No exclusion criteria besides the contraindications for the use of Gadovist as mentioned in the German product information.
Both
7 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00874640
14317, GV0810DE
No
Bayer
Bayer
Not Provided
Study Director: Bayer Study Director Bayer
Bayer
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP