Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement Surgery

NCT ID: NCT00917254

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

PHASE2/PHASE3

Total Enrollment

369 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-05-31

Study Completion Date

2010-01-31

Brief Summary

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The purpose of this study is to examine the superiority of YM150 to the placebo and to evaluate the dose-dependent response of YM150 in patients undergoing elective total knee replacement surgery.

Detailed Description

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Conditions

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Venous Thromboembolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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YM150 group-1

YM150 low dose group

Group Type EXPERIMENTAL

YM150

Intervention Type DRUG

oral

YM150 group-2

YM150 high dose group

Group Type EXPERIMENTAL

YM150

Intervention Type DRUG

oral

Placebo group

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral

Enoxaparin group

Group Type ACTIVE_COMPARATOR

Enoxaparin

Intervention Type DRUG

injection

Interventions

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YM150

oral

Intervention Type DRUG

Placebo

oral

Intervention Type DRUG

Enoxaparin

injection

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subjects is scheduled for elective primary total knee replacement surgery
* 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, retinopathy, hypertension, or thrombocytopenia
* Subject is receiving anticoagulants/antiplatelets
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

Hokkaido, , Japan

Site Status

Kansai, , Japan

Site Status

Kantou, , Japan

Site Status

Kyusyu, , Japan

Site Status

Tōhoku, , Japan

Site Status

Changhua, , Taiwan

Site Status

Chiayi City, , Taiwan

Site Status

Kaohsiung City, , Taiwan

Site Status

Taichung, , Taiwan

Site Status

Bangkok, , Thailand

Site Status

Chiang Mai, , Thailand

Site Status

Countries

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Japan Taiwan Thailand

Other Identifiers

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150-CL-031

Identifier Type: -

Identifier Source: org_study_id

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