None listed
Conditions
Interventions
Intervention1: YM150: Oral, Dose X twice daily, Dose X once daily, Dose Y twice daily, Dose Y once daily
Control Intervention1: NIL: NIL
Sponsors
Astellas Pharma Inc.
ICON Clinical Research India Pvt Limited
Eligibility
Inclusion criteria
Inclusion criteria: Male or female subject aged 18 years or older. Subject is scheduled for elective hip replacement surgery.
Exclusion criteria
Exclusion criteria: - Subject has active bleeding or any condition associated with increased risk of bleeding - Subject has had major trauma or surgery within 3 months before planned hip replacement surgery or requires major surgery or other invasive procedures with potential for uncontrolled bleeding during the study - Subject has had an MI or stroke within 3 months before planned hip replacement surgery
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Symptomatic Venous Thromboembolisms and Death from all causes Time Frame: 12 days Timepoint: Time Frame: 12 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 1) Incidence of All Venous Thromboembolic events Time Frame : Until day 12, during the treatment period, follow-up period and entire study period 2) Incidence of Bleeding events Time Frame : During the treatment period, follow-up period and entire study period Timepoint: Until day 12, during he treatment period, follow-up period and entire study period. | — |
Countries
India
Contacts
Public ContactDr. Venkataraghuram Muppavarapu
Outcome results
None listed