NCT00874640

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,711

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 31, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 2, 2009

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

February 20, 2014

Status Verified

February 1, 2014

Enrollment Period

2.5 years

First QC Date

March 31, 2009

Last Update Submit

February 19, 2014

Conditions

Epidemiologic Factors

Keywords

Drug utilization review

Outcome Measures

Primary Outcomes (1)

  • Patient Profile

    At day of application

Secondary Outcomes (2)

  • Dosing of Gadovist in different indications

    At time of application

  • Adverse Events

    Throughout and after application

Study Arms (1)

Group 1

Biological: Gadobutrol (Gadovist, BAY86-4875)

Interventions

Gadobutrol (Gadovist, BAY86-4875)BIOLOGICAL

Patients with indication for a MRT or MR-Angiography and for whom the radiologist has decided to use the contrast medium gadobutrol

Group 1

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Radiological practice

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Many Locations, Germany

Location

MeSH Terms

Interventions

gadobutrol

Study Officials

  • Bayer Study Director

    Bayer

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 31, 2009

First Posted

April 2, 2009

Study Start

March 1, 2009

Primary Completion

September 1, 2011

Study Completion

November 1, 2011

Last Updated

February 20, 2014

Record last verified: 2014-02

Locations

DE(1)