Venous Thromboembolism
Conditions
Keywords
YM150, Bleeding, VTE, FXa inhibitor, Deep Vein Thrombosis, Venous thromboembolism
Brief summary
To evaluate the safety and efficacy of the oral dose of YM150 for prevention of venous thromboembolism (VTE) in patients with acute medical illness.
Interventions
DRUGYM150
oral
Sponsors
Astellas Pharma Inc
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient is hospitalized within 2 days before the study and has more than 1 basic VTE risks * Complete bed rest is required in the fist day of hospitalization and at least 4 days hospitalization * Written informed consent obtained
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 obtaining informed consent * 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 * Major trauma, major surgery, eye, spinal cord and/or brain surgery within 90 days prior to obtaining informed consent, or the subject scheduled for these surgeries during the study periods
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite assessment of VTE events and all cause death | Until day 28 |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of bleeding events | Until day 28 |
Countries
Japan
Outcome results
None listed