A Study to Evaluate the Safety and Efficacy of YM150 in Patients With Knee Replacement Surgery

NCT ID: NCT00595426

Last Updated: 2013-03-25

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

Total Enrollment

685 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2009-05-31

Brief Summary

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To evaluate the safety and efficacy of twice daily dosing and once daily dosing of YM150 in subjects undergoing primary elective knee replacement surgery

Detailed Description

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Conditions

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Arthroplasty, Replacement, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1. YM150 Dose X, twice daily

Group Type EXPERIMENTAL

YM150

Intervention Type DRUG

Oral

2. YM150 Dose Y, once daily

Group Type EXPERIMENTAL

YM150

Intervention Type DRUG

Oral

3. YM150 Dose Y, twice daily

Group Type EXPERIMENTAL

YM150

Intervention Type DRUG

Oral

4. YM150 Dose Z, once daily

Group Type EXPERIMENTAL

YM150

Intervention Type DRUG

Oral

5. Warfarin

various doses

Group Type ACTIVE_COMPARATOR

Warfarin

Intervention Type DRUG

Oral

Interventions

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YM150

Oral

Intervention Type DRUG

Warfarin

Oral

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subject is scheduled for elective primary knee arthroplasty
* Written Informed consent obtained

Exclusion Criteria

* Subject has documented history of previous VTE
* Subject is considered to be at increased risk of VTE
* Subject has active bleeding or any condition associated with increased risk of bleeding
* Subject is planning to have surgery on the contralateral knee at the same time or within 6 weeks after enrollment into the study
Minimum Eligible Age

18 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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Responsibility Role SPONSOR

Principal Investigators

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Central Contact

Role: STUDY_DIRECTOR

Astellas Pharma Global Development

Locations

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Mobile, Alabama, United States

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Phoenix, Arizona, United States

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Tuscon, Arizona, United States

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Little Rock, Arkansas, United States

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Fountain Valley, California, United States

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La Mesa, California, United States

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Long Beach, California, United States

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Long Beach, California, United States

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San Diego, California, United States

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Santa Ana, California, United States

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Torrance, California, United States

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Yuba City, California, United States

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Aurora, Colorado, United States

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Denver, Colorado, United States

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Lone Tree, Colorado, United States

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Washington D.C., District of Columbia, United States

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Bay Pines, Florida, United States

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Bradenton, Florida, United States

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Gulf Breeze, Florida, United States

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Hollywood, Florida, United States

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St. Petersburg, Florida, United States

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St. Petersburg, Florida, United States

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Decatur, Georgia, United States

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Savannah, Georgia, United States

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Boise, Idaho, United States

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Idaho Falls, Idaho, United States

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Springfield, Illinois, United States

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Springfield, Illinois, United States

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Baltimore, Maryland, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Tulsa, Oklahoma, United States

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Charleston, South Carolina, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Grapevine, Texas, United States

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Houston, Texas, United States

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Lubbock, Texas, United States

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Lubbock, Texas, United States

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Odessa, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Red Deer, Alberta, Canada

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Ajax, Ontario, Canada

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Burlington, Ontario, Canada

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Montreal, Ontario, Canada

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Newmarket, Ontario, Canada

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Saint Catherines, Ontario, Canada

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Scarborough Village, Ontario, Canada

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Thunder Bay, Ontario, Canada

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Waterloo, Ontario, Canada

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Charlottetown, Prince Edward Island, Canada

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Countries

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United States Canada

Other Identifiers

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150-CL-033

Identifier Type: -

Identifier Source: org_study_id

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