Factor Xa Inhibitor for Prevention of Venous Thromboembolism in Patients Undergoing Elective Total Knee Replacement
NCT ID: NCT00408239
Last Updated: 2011-12-19
Study Results
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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COMPLETED
PHASE2
367 participants
INTERVENTIONAL
2006-12-31
2009-03-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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1
Dose regimen 1
YM150
Oral
2
enoxaparin
Sub cutaneous
3
Dose regimen 2
YM150
Oral
Interventions
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YM150
Oral
enoxaparin
Sub cutaneous
Eligibility Criteria
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Inclusion Criteria
* Legal minimum age requirement ( country-specific)
* Written informed consent has been obtained
Exclusion Criteria
* Subjects considered to be at increased risk of bleeding:
* Known hemorrhagic disorder and/or coagulation disorder
* Thrombocytopenia
* Clinically important bleeding occurred within 3 months prior to the screening visit
* Acute bacterial endocarditis
* Severe hypertension
* Retinopathy
* Concomitant use of anticoagulants / antiplatelet agents (including homeopathic drugs) and/or anticipated postoperative need for other reasons than prevention of DVT during the study period.
18 Years
ALL
No
Sponsors
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Astellas Pharma Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Central Contact
Role: STUDY_CHAIR
Astellas Pharma Inc
Locations
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Jakarta, , Indonesia
Chubu Region, , Japan
Chugoku Region, , Japan
Kansai Region, , Japan
Kanto Region, , Japan
Kyushyu Region, , Japan
Shikoku Region, , Japan
Tohoku Region, , Japan
Kelantan, , Malaysia
Kuala Lumpur, , Malaysia
Manila, , Philippines
Quezon City, , Philippines
Singapore, , Singapore
Incheon, , South Korea
Jeonnam, , South Korea
Seoul, , South Korea
Kaohsiung City, , Taiwan
Bangkok, , Thailand
Chiang Mai, , Thailand
Countries
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Other Identifiers
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150-CL-029
Identifier Type: -
Identifier Source: org_study_id