Prevention of Recurrence of Venous Thromboembolism in Patients With a History of Venous Thromboembolism

Phase 3

Completed

• Conditions: Venous Thromboembolism
• Interventions: Drug: YM150

• Registration Number: NCT00937820
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

The study objective is to evaluate the efficacy and safety of oral YM150 for 52 weeks in patients with a history of venous thromboembolism.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-07-09
• Study First Submitted QC: 2009-07-10
• Study First Posted: 2009-07-13
• Primary Completion: 2010-12
• Study Completion: 2010-12
• Status Verified: 2011-01
• Last Update Submitted: 2011-01-05
• Last Update Posted: 2011-01-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 87

Inclusion Criteria

• Subject has symptomatic VTE and/or asymptomatic deep vein thrombosis
• Written informed consent obtained before screening

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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 the screening visit
• 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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
YM150 group	YM150	-

Primary Outcome Measures

Name	Time	Method
Joint incidence of deep vein thromboembolism or pulmonary thromboembolism	52 weeks

Secondary Outcome Measures

Name	Time	Method
Incidence of bleeding event	52 weeks
All cause mortality	52 weeks
Incidence of each thromboembolism	52 weeks