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

NCT ID: NCT00937820

Last Updated: 2011-01-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

87 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-06-30

Study Completion Date

2010-12-31

Brief Summary

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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

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Conditions

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Venous Thromboembolism

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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YM150 group

Group Type EXPERIMENTAL

YM150

Intervention Type DRUG

oral

Interventions

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YM150

oral

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astellas Pharma Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Astellas Pharma, Inc

Principal Investigators

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Use Central Contact

Role: STUDY_CHAIR

Astellas Pharma Inc

Locations

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Chugoku, , Japan

Site Status

Chūbu, , Japan

Site Status

Kansai, , Japan

Site Status

Kantou, , Japan

Site Status

Tōhoku, , Japan

Site Status

Countries

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Japan

Other Identifiers

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150-CL-104

Identifier Type: -

Identifier Source: org_study_id

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