Trials / Completed
CompletedNCT01582737
Xarelto [SPAF] Post-marketing Surveillance in Japan
Special Drug Use Investigation of Xarelto [SPAF]
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 11,310 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 0 Years
- 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 Xarelto for SPAF. The objective of this study is to assess safety and effectiveness of Xarelto using in real clinical practice. A total of 10,000 patients are to be enrolled and assessed in 2 years standard observational period. An annual follow-up survey will be conducted for 5 years at the longest after standard observational period.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Rivaroxaban(Xarelto, BAY59-7939) | Patients treated with Xarelto under practical manner |
Timeline
- Start date
- 2012-05-30
- Primary completion
- 2019-03-31
- Completion
- 2020-01-17
- First posted
- 2012-04-23
- Last updated
- 2023-07-24
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT01582737. Inclusion in this directory is not an endorsement.