Drug Use Investigation of Gadovist.
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|ClinicalTrials.gov Identifier: NCT02540967|
Recruitment Status : Completed
First Posted : September 4, 2015
Last Update Posted : October 29, 2018
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|Condition or disease||Intervention/treatment|
|Magnetic Resonance Imaging Image Enhancement||Drug: Gadobutrol (Gadavist/Gadovist, BAY86-4875)|
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|
|Actual Enrollment :||3357 participants|
|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|
Gadovist administration goup
Drug: Gadobutrol (Gadavist/Gadovist, BAY86-4875)
Gadovist dosage following summary of product characteristics
- Number of episodes of adverse events as a measure of safety and tolerability [ Time Frame: Up to 3 days ]
- Number of episodes of adverse drug reactions and adverse events [ Time Frame: Up to 3 days ]In subpopulations
- Contrast enhancement [ Time Frame: At the time of MRI ]
Investigator Discretion as very improved , improved, not changed, degraded, not evaluable.
MRI- Magnetic Resonance Imaging
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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|
- Patients who perform contrast enhanced Magnetic Resonance Imaging (MRI) with Gadovist.
- Patients who are contraindicated based on approved label.
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
|Multiple Locations, Japan|
|Study Director:||Bayer Study Director||Bayer|
|Other Study ID Numbers:||
|First Posted:||September 4, 2015 Key Record Dates|
|Last Update Posted:||October 29, 2018|
|Last Verified:||October 2018|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Contrast enhancement in the following MR imaging
Brain and spine
Body and extremities