Patient Characteristics in Daily Radiological Practice of... | NCT00874640

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

NCT00874640

Sponsor

Bayer

Status

Completed

Last Update Posted

Feb 20, 2014Estimated

Enrollment

3,711Actual

Phase

Not provided

Conditions

Epidemiologic Factors

Interventions

Gadobutrol (Gadovist, BAY86-4875)

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
GV0810DE	Other Identifier	Company internal

Status Module

Record Verification Date

Feb 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2009

Primary Completion Date

Sep 2011Actual

Completion Date

Nov 2011Actual

First Submitted Date

Mar 31, 2009

First Submission Date that Met QC Criteria

Apr 1, 2009

First Posted Date

Apr 2, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 19, 2014

Last Update Posted Date

Feb 20, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,711Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Group 1			Biological: Gadobutrol (Gadovist, BAY86-4875)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Patient Profile		At day of application

Secondary Outcomes

Measure	Description	Time Frame
Dosing of Gadovist in different indications		At time of application
Adverse Events		Throughout and after application

Other Outcomes

Not provided

Eligibility Module

Eligibility 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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

7 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Radiological practice

Sampling Method

Non-Probability Sample

Name	Affiliation	Role
Bayer Study Director	Bayer	Study Director

Intervention Browse Module

MeSH Terms

ID	Term
C090600	gadobutrol

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided