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

Astellas

Status and phase: Completed; Phase 3

Conditions: Venous Thromboembolism

Treatments: Drug: YM150

Study type: Interventional

Funder types: Industry

Identifiers

NCT00937820

150-CL-104

Details and patient eligibility

About

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

Enrollment: 87 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

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

Trial design

Primary purpose: Prevention

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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87 participants in 1 patient group

YM150 group

Experimental group

Treatment:

Drug: YM150