Trials / Completed
CompletedNCT01411449
Primovist Post-marketing Surveillance in Japan
Drug Use Investigation of EOB-Primovist Inj. Syringe
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 2,030 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This study is a regulatory post marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Primovist for contrast enhancement in MRI of liver. The objective of this study is to assess safety, especially in relation to renal dysfunction, and efficacy of using Primovist in clinical practice. A total 2,000 patients for diagnosis on detection and identify hepatic tumor will be recruited and followed 7 days after the injection.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Gadoxetic Acid Disodium (Primovist, BAY86-4873) | Patients who will need to undergo contrast enhanced MRI with Primovist |
Timeline
- Start date
- 2008-03-11
- Primary completion
- 2010-12-14
- Completion
- 2015-02-18
- First posted
- 2011-08-08
- Last updated
- 2017-03-17
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT01411449. Inclusion in this directory is not an endorsement.