Phase IIa Venous Thromboembolism (VTE) Prevention Study In Total Knee Replacement (TKR)

NCT ID: NCT00541320

Last Updated: 2013-04-04

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

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Brief Summary

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This study was designed to assess the safety and efficacy of GW813893 in the prophylaxis of VTE following TKR and to provide evidence to enable the selection of the appropriate dose(s) and dose regimen of GW813893 for future investigation.

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

DOUBLE

Interventions

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GW813893

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Patients who are scheduled for primary elective unilateral total knee arthroplasty.

Exclusion Criteria

* Women who are not surgically sterile or post-menopausal
* Have a contra-indication to contract venography
* Have a known disorder associated with increased risk of bleeding or have been immobile up to 12 weeks before surgery.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Principal Investigators

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GSK Clinical Trials, MD

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Clinical Trials Call Center

Birmingham, Alabama, United States

Site Status

GSK Clinical Trials Call Center'

Phoenix, Arizona, United States

Site Status

GSK Clinical Trials Call Center

Phoenix, Arizona, United States

Site Status

GSK Clinical Trials Call Center

Yuba City, California, United States

Site Status

GSK Clinical Trials Call Center

St. Petersburg, Florida, United States

Site Status

GSK Clinical Trials Call Center

Decatur, Georgia, United States

Site Status

GSK Clinical Trials Call Center

Charleston, South Carolina, United States

Site Status

GSK Clinical Trials Call Center

San Antonio, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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FTI102595

Identifier Type: -

Identifier Source: org_study_id

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