Drug Use Investigation of Gadovist.

November 6, 2023 updated by: Bayer

Drug Use Investigation of Gadovist

The objectives of this study are to investigate the safety and effectiveness of Gadovist.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a prospective, non-interventional, continuous submission safety study that includes patients who planned Gadolinium (Gd) contrast enhanced Magnetic Resonance Imaging (MRI) in accordance with approved label. The investigator will have made the choice of Gd enhanced MRI (the decision to use Gadovist according the Japanese Package Insert prior to enrolling the patient in this study).

The study period is 3 years. Data analysis period is 1 year. In total, 3300 patients will be recruited.

For each patient, data are collected as defined in the case report form (CRF) at the visit for MRI examination (as per investigators routine practice).

Study Type

Observational

Enrollment (Actual)

3357

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Multiple Locations, Japan
        • Many Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Female and male patients who planned Gd contrast enhanced MRI in accordance with approved label. Eligible patients who receive Gadovist will be enrolled and documented in the eCRF

Description

Inclusion Criteria:

  • Patients who perform contrast enhanced Magnetic Resonance Imaging (MRI) with Gadovist.

Exclusion Criteria:

  • Patients who are contraindicated based on approved label.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
BAY86-4875
Gadovist administration goup
Drug: Gadobutrol (Gadavist/Gadovist, BAY86-4875)
Gadovist dosage following summary of product characteristics

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of episodes of adverse events as a measure of safety and tolerability
Time Frame: Up to 3 days
Up to 3 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of episodes of adverse drug reactions and adverse events
Time Frame: Up to 3 days
In subpopulations
Up to 3 days
Contrast enhancement
Time Frame: At the time of MRI

Investigator Discretion as very improved , improved, not changed, degraded, not evaluable.

MRI- Magnetic Resonance Imaging
At the time of MRI

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Investigators

  • Study Director: Bayer Study Director, Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 27, 2015

Primary Completion (Actual)

November 2, 2017

Study Completion (Actual)

November 2, 2017

Study Registration Dates

First Submitted

September 2, 2015

First Submitted That Met QC Criteria

September 3, 2015

First Posted (Estimated)

September 4, 2015

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 6, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 17512

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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