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Trial record 1 of 1 for:    NCT02540967
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Drug Use Investigation of Gadovist.

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: NCT02540967
Recruitment Status : Completed
First Posted : September 4, 2015
Last Update Posted : October 29, 2018
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
The objectives of this study are to investigate the safety and effectiveness of Gadovist.

Condition or disease Intervention/treatment
Magnetic Resonance Imaging Image Enhancement Drug: Gadobutrol (Gadavist/Gadovist, BAY86-4875)

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 Design
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Study Type : Observational
Actual Enrollment : 3357 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Drug Use Investigation of Gadovist
Actual Study Start Date : October 27, 2015
Actual Primary Completion Date : November 2, 2017
Actual Study Completion Date : November 2, 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Gadobutrol

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


Outcome Measures
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Primary Outcome Measures :
  1. Number of episodes of adverse events as a measure of safety and tolerability [ Time Frame: Up to 3 days ]

Secondary Outcome Measures :
  1. Number of episodes of adverse drug reactions and adverse events [ Time Frame: Up to 3 days ]
    In subpopulations

  2. Contrast enhancement [ Time Frame: At the time of MRI ]

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

    MRI- Magnetic Resonance Imaging



Eligibility Criteria
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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.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Patients who are contraindicated based on approved label.
Contacts and Locations
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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): NCT02540967


Locations
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Japan
Many Locations
Multiple Locations, Japan
Sponsors and Collaborators
Bayer
Investigators
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Study Director: Bayer Study Director Bayer
More Information
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Additional Information:

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT02540967    
Other Study ID Numbers: 17512
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: October 29, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Contrast enhancement in the following MR imaging
Brain and spine
Body and extremities
Gadobutrol