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

NCT ID: NCT01028950

Last Updated: 2010-06-16

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

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-04-30

Brief Summary

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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

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Conditions

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Venous Thromboembolism

Study Design

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Allocation Method

NA

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

* 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
Minimum Eligible Age

40 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-044

Identifier Type: -

Identifier Source: org_study_id

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