Venous Thromboembolism (VTE) Treatment Study in Japanese Pulmonary Embolism (PE) Patients

Bayer

Status and phase

Completed

Phase 3

Conditions

Pulmonary Embolism

Treatments

Drug: Rivaroxaban (Xarelto, BAY59-7939)

Drug: Unfractionated heparin

Drug: Warfarin

Study type

Interventional

Funder types

Industry

Identifiers

NCT01516814

15960

Details and patient eligibility

About

The objective of this study is to evaluate the efficacy, safety, pharmacokinetics (PK) and pharmacodynamics (PD) of rivaroxaban in the treatment of pulmonary embolism (PE) and the prevention of the occurrence and the recurrence of deep vein thrombosis (DVT) or PE in Japanese patients with acute symptomatic PE with or without symptomatic DVT.

Enrollment

40 patients

Sex

All

Ages

20+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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