Trial Condition(s):
Magnetic Resonance Imaging
Drug Use Investigation of Gadovist.
Bayer Identifier:
17512
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Study Completed
Trial Purpose
The objectives of this study are to investigate the safety and effectiveness of Gadovist.
Inclusion Criteria
- Patients who perform contrast enhanced Magnetic Resonance Imaging (MRI) with Gadovist.
Exclusion Criteria
- Patients who are contraindicated based on approved label.
Trial Summary
Enrollment Goal
3357
Trial Dates
Phase
N/A
Could I receive a placebo?
No
Products
Gadavist/Gadovist (Gadobutrol, BAY86-4875)
Accepts Healthy Volunteers
No
Where to Participate
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Locations
| Locations | |
|---|---|
Locations Many Locations Many Locations, Japan | Contact Us: E-mail: [email protected] Phone: (+) 1-888-8422937 |
Trial Design
Drug Use Investigation of Gadovist
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Number of episodes of adverse events as a measure of safety and tolerabilityTimeframe: Up to 3 days
Secondary Outcome
- Number of episodes of adverse drug reactions and adverse eventsIn subpopulationsTimeframe: Up to 3 days
- Contrast enhancementInvestigator Discretion as very improved , improved, not changed, degraded, not evaluable. MRI- Magnetic Resonance ImagingTimeframe: At the time of MRI
Additional Information
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