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

Phase 3

Completed

• Conditions: Venous Thromboembolism
• Interventions: Drug: YM150

• Registration Number: NCT01028950
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-05
• Study First Submitted: 2009-12-07
• Study First Submitted QC: 2009-12-08
• Study First Posted: 2009-12-09
• Primary Completion: 2010-04
• Study Completion: 2010-04
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-14
• Last Update Posted: 2010-06-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
YM150 group	YM150	-

Primary Outcome Measures

Name	Time	Method
Composite assessment of VTE events and all cause death	Until day 28

Secondary Outcome Measures

Name	Time	Method
Incidence of bleeding events	Until day 28