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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00874640
First Posted: April 2, 2009
Last Update Posted: February 20, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bayer
  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:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Patient Profile [ Time Frame: At day of application ]

Secondary Outcome Measures:
  • Dosing of Gadovist in different indications [ Time Frame: At time of application ]
  • Adverse Events [ Time Frame: Throughout and after application ]

Enrollment: 3711
Study Start Date: March 2009
Study Completion Date: November 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   7 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00874640


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

Additional Information:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00874640     History of Changes
Other Study ID Numbers: 14317
GV0810DE ( Other Identifier: Company internal )
First Submitted: March 31, 2009
First Posted: April 2, 2009
Last Update Posted: February 20, 2014
Last Verified: February 2014

Keywords provided by Bayer:
Drug utilization review