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

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00874640
First received: March 31, 2009
Last updated: February 22, 2013
Last verified: February 2013
History of Changes
  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).


Condition Intervention
Epidemiologic Factors
 Biological: Gadobutrol (Gadovist, BAY86-4875)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Characteristics in Daily Radiological Practice of Gadovist® Application (PATRON)

Resource links provided by NLM:

Drug Information available for: Gadobutrol
U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Patient Profile [ Time Frame: At day of application ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 3711
Study Start Date: March 2009
Study Completion Date: September 2011
Groups/Cohorts Assigned Interventions
Group 1 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

  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Radiological practice

Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00874640

Locations
Germany
Many Locations, Germany
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site
Click here to find results for studies related to Bayer Healthcare products.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Medical Director, Bayer Vital GmbH
ClinicalTrials.gov Identifier: NCT00874640     History of Changes
Other Study ID Numbers: 14317, GV0810DE
Study First Received: March 31, 2009
Last Updated: February 22, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Drug utilization review

ClinicalTrials.gov processed this record on May 23, 2013