Overview

Venous Thromboembolism (VTE) Treatment Study in Japanese Deep Vein Thrombosis (DVT) Patients

Status:
Completed
Trial end date:
2014-01-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Bayer
Collaborator:
Janssen Scientific Affairs, LLC
Treatments:
Calcium heparin
Heparin
Rivaroxaban
Warfarin
Criteria
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