Odiparcil For The Prevention Of Venous Thromboembolism

NCT ID: NCT00244725

Last Updated: 2017-05-02

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

961 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-09-30

Study Completion Date

2006-09-30

Brief Summary

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Odiparcil is being studied to determine if it can prevent blood clots from forming after a total knee replacement and also to prove that odiparcil is safe.

Detailed Description

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Conditions

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Deep Vein Thrombosis Fibrillation, Atrial Venous Thromboembolism Pulmonary Embolism

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Interventions

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Odiparcil

Intervention Type DRUG

Warfarin

Intervention Type DRUG

Coumadin

Intervention Type DRUG

Other Intervention Names

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Odiparcil Warfarin

Eligibility Criteria

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Inclusion Criteria

* Women must be unable to have children.
* Will have a total knee replacement.

Exclusion Criteria

* Allergic to any X-ray dye.
* Allergies or reactions to warfarin or coumadin.
* Previous VTE (venous thromboembolism) or deep vein thrombosis (DVT).
* On anticoagulation therapy.
* Renal impairment.
* Participated in any clinical trial in the past 30 days.
Minimum Eligible Age

35 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Birmingham, Alabama, United States

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Mobile, Alabama, United States

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Phoenix, Arizona, United States

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Little Rock, Arkansas, United States

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Banning, California, United States

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Sacramento, California, United States

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Torrance, California, United States

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Yuba City, California, United States

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Colorado Springs, Colorado, United States

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Lonetree, Colorado, United States

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Clearwater, Florida, United States

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DeLand, Florida, United States

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Jacksonville, Florida, United States

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Sarasota, Florida, United States

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Sarsota, Florida, United States

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St. Petersburg, Florida, United States

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Decatur, Georgia, United States

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Boise, Idaho, United States

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Lexington, Kentucky, United States

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Baton Rouge, Louisiana, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Baltimore, Maryland, United States

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Warren, Michigan, United States

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Mineola, New York, United States

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Charlotte, North Carolina, United States

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Durham, North Carolina, United States

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Cincinnati, Ohio, United States

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Cleveland, Ohio, United States

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Toledo, Ohio, United States

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Allentown, Pennsylvania, United States

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Altoona, Pennsylvania, United States

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Camp Hill, Pennsylvania, United States

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Hershey, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Lubbock, 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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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Richmond, Virginia, United States

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Huntington, West Virginia, United States

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Marshfield, Wisconsin, United States

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Camperdown, New South Wales, Australia

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Southport, Queensland, Australia

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Box Hill, Victoria, Australia

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Clayton, Victoria, Australia

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Geelong, Victoria, Australia

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Ringwood East, Victoria, Australia

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Windsor, Victoria, Australia

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Porto Alegre, Rio Grande do Sul, Brazil

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Porto Alegre, Rio Grande do Sul, Brazil

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Winnipeg, Manitoba, Canada

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Ajax, Ontario, Canada

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Don Mills, Ontario, Canada

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Newmarket, Ontario, Canada

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North York, Ontario, Canada

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Oshawa, Ontario, Canada

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Scarborough Village, Ontario, Canada

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Waterloo, Ontario, Canada

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Charlottetown, Prince Edward Island, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Sainte Jerome, Quebec, Canada

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Chennai, , India

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Secunderabad, , India

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Haifa, , Israel

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Kfar Saba, , Israel

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Petah Tikva, , Israel

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Tel Aviv, , Israel

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Riga, , Latvia

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Riga, , Latvia

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Kaunas, , Lithuania

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Klaipėda, , Lithuania

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Vilnius, , Lithuania

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Bialystok, , Poland

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Krakow, , Poland

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Sosnowiec, , Poland

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Wroclaw, , Poland

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Irkutsk, , Russia

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Kurgan, , Russia

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Moscow, , Russia

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Mosocow, , Russia

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Mosocow, , Russia

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Rostov-on-Don, , Russia

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Pretoria, Gauteng, South Africa

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Centurion, , South Africa

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Pretoria, , South Africa

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Cherkasy, , Ukraine

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Dnipro, , Ukraine

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Kyiv, , Ukraine

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Kyiv, , Ukraine

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Vinnitsa, , Ukraine

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Birmingham, West Midlands, United Kingdom

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Bournmouth, , United Kingdom

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Fife, , United Kingdom

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London, , United Kingdom

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Wigan, , United Kingdom

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Countries

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United States Australia Brazil Canada India Israel Latvia Lithuania Poland Russia South Africa Ukraine United Kingdom

Other Identifiers

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ITI101711

Identifier Type: -

Identifier Source: org_study_id

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