Venous Thromboembolism
Conditions
Keywords
YM150, Bleeding, VTE, FXa inhibitor, Venous thromboembolism
Brief summary
The study objective is to evaluate the efficacy and safety of oral YM150 for 52 weeks in patients with a history of venous thromboembolism.
Interventions
DRUGYM150
oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subject has symptomatic VTE and/or asymptomatic deep vein thrombosis * Written informed consent obtained before screening
Exclusion criteria
* Subject has history of deep vein thrombosis and/or pulmonary embolism * Subject has a hemorrhagic disorder and/or coagulation disorder * Subject has had clinically important bleeding occurred within 90 days prior to the screening visit * Subject has an acute bacterial endocarditis * Subject has uncontrolled severe or moderate hypertension, retinopathy, myocardial infarction or stroke * Subject is receiving anticoagulants/antiplatelet agents * Subject has a body weight less than 40 kg
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Joint incidence of deep vein thromboembolism or pulmonary thromboembolism | 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of each thromboembolism | 52 weeks |
| All cause mortality | 52 weeks |
| Incidence of bleeding event | 52 weeks |
Countries
Japan
Outcome results
None listed