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NCT01885585 Clinical Trial

Eliquis Regulatory Post Marketing Surveillance (rPMS)

Venous Thromboembolism Clinical Trial

Official title:
Eliquis (Apixaban) Regulatory Post Marketing Surveillance in Clinical Practice for Venous Thromboembolism (VTE) Prevention

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01885585
Other study ID # CV185-222
Secondary ID
Status Completed
Phase N/A
First received June 21, 2013
Last updated February 5, 2016
Start date July 2014
Est. completion date May 2015

Study information
Verified date February 2016
Source Bristol-Myers Squibb
Contact n/a
Is FDA regulated No
Health authority Korea: Ministry of Food and Drug Safety
Study type Observational

Clinical Trial Summary

The objective of this regulatory Post-Marketing Surveillance in Korea is to reconfirm the clinical usefulness of Eliquis through collecting, reviewing, identifying and verifying the safety and effectiveness information about Eliquis in general practice

Recruitment information / eligibility
Status Completed
Enrollment 100
Est. completion date May 2015
Est. primary completion date May 2015
Accepts healthy volunteers No
Gender Both
Age group 19 Years and older
Eligibility Inclusion Criteria:

- Signed data release

- Patients undergoing elective total hip replacement arthroplasty or elective total knee replacement arthroplasty

Exclusion Criteria:

- Being treated for an indication not approved for the use of Eliquis® in Korea

- Is contraindicated for the use of Eliquis® as described in the Korean label

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Apixaban

Locations
Country Name City State
Korea, Republic of Local Institution Seoul

Sponsors (1)
Lead Sponsor Collaborator
Bristol-Myers Squibb

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of Adverse Events (AEs) and serious AEs Up to 30 days after last study drug dose Yes
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