check_circleStudy Completed
Venous Thromboembolism
Bayer Identifier:
14793
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
Xarelto regulatory Post-Marketing Surveillance
Trial purpose
This study is to identify the following problems and questions with respect to the safety and effectiveness of Xarelto in comparison with other pharmacologic agents in the prophylaxis of venous thromboembolism (VTE) in a large sample of patients who undergo elective total hip replacement (THR) or total knee replacement (TKR) in the real-life conditions in its registered indication(s) as required by Korean Food and Drug Administration (KFDA).
1) Known and unknown adverse reactions, especially serious adverse reactions
2) Incidence of adverse reactions under the routine drug use
3) Factors that may affect the safety of the drug
4) Factors that may affect the effectiveness of the drug
5) Other safety information related to overuse, drug interaction and laboratory abnormalities
6) Other adverse reactions
1) Known and unknown adverse reactions, especially serious adverse reactions
2) Incidence of adverse reactions under the routine drug use
3) Factors that may affect the safety of the drug
4) Factors that may affect the effectiveness of the drug
5) Other safety information related to overuse, drug interaction and laboratory abnormalities
6) Other adverse reactions
Key Participants Requirements
Sex
BothAge
18 - N/ATrial summary
Enrollment Goal
3388Trial Dates
December 2009 - January 2016Phase
N/ACould I Receive a placebo
NoProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Many Locations, Korea, Republic Of |
Primary Outcome
- Adverse event collectiondate_rangeTime Frame:From the start of signed consent to 4 weeks after dischargeenhanced_encryptionyesSafety Issue:
Secondary Outcome
- Duration of treatmentdate_rangeTime Frame:Whole treatment periodenhanced_encryptionnoSafety Issue:
Trial design
Trial Type
ObservationalIntervention Type
DrugTrial Purpose
N/AAllocation
N/ABlinding
N/AAssignment
N/ATrial Arms
N/A