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

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.
ClinicalTrials.gov Identifier: NCT00874640
Recruitment Status : Completed
First Posted : April 2, 2009
Last Update Posted : February 20, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:

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 or disease Intervention/treatment
Epidemiologic Factors Biological: Gadobutrol (Gadovist, BAY86-4875)

Study Design

Study Type : Observational
Actual Enrollment : 3711 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Patient Characteristics in Daily Radiological Practice of Gadovist® Application (PATRON)
Study Start Date : March 2009
Primary Completion Date : September 2011
Study Completion Date : November 2011

Resource links provided by the National Library of Medicine

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

Groups and Cohorts

Group/Cohort Intervention/treatment
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


Outcome Measures

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

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

Eligibility Criteria

Information from the National Library of Medicine

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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 Posted: April 2, 2009    Key Record Dates
Last Update Posted: February 20, 2014
Last Verified: February 2014

Keywords provided by Bayer:
Drug utilization review