YM150 for Prevention of Venous Thromboembolism in Patients With Acute Medical Illness

Astellas

Status and phase

Completed

Phase 3

Conditions

Venous Thromboembolism

Treatments

Drug: YM150

Study type

Interventional

Funder types

Industry

Identifiers

150-CL-044

Details and patient eligibility

About

To evaluate the safety and efficacy of the oral dose of YM150 for prevention of venous thromboembolism (VTE) in patients with acute medical illness.

Enrollment

52 patients

Sex

All

Ages

40+ years old

Volunteers

No Healthy Volunteers

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