Venous Thromboembolism (VTE) Treatment Study in Japanese Deep Vein Thrombosis (DVT) Patients
Venous Thromboembolism (VTE) Treatment Study in Japanese Deep Vein Thrombosis (DVT) Patients
The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and
 pharmacodynamics (PD) of two different dosages of rivaroxaban in the treatment of deep vein
 thrombosis (DVT) and the prevention of the occurrence and the recurrence of DVT or pulmonary
 embolism (PE) in Japanese patients with acute symptomatic DVT without symptomatic PE.
The general design of the trial is open label between the Rivaroxaban and the reference arm.
 However, there are two groups in the Rivaroxaban arm only for the initial 3 weeks. Between
 these two groups and in this initial period, the study is blinded.
Inclusion Criteria:

 -  Men and women >/= 20 years of age in patients with confirmed acute symptomatic
 proximal deep vein thrombosis (DVT) without symptomatic pulmonary embolism (PE)

 Exclusion Criteria:

 -  Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the
 current episode of DVT

 -  More than 48 hours pre-randomization treatment with therapeutic dosages of
 anti-coagulant treatment or more than a single dose of warfarin from the onset of the
 current episode of DVT to randomization

 -  Calculated creatinine clearance (CLCR) < 30 mL/min

 -  Subjects with hepatic disease which is associated with coagulopathy leading to a
 clinically relevant bleeding risk

 -  Active bleeding or high risk for bleeding contraindicating treatment with unfractioned
 Heparin (UFH) or warfarin

 -  Systolic blood pressure > 180 mmHg or diastolic blood pressure > 110 mmHg