Brief Summary

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.

Trial Health

At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach

1 country

8 active sites

Status

withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed

11 days until next milestone

First Submitted

Initial submission to the registry

February 12, 2007

Completed

8 months until next milestone

First Posted

Study publicly available on registry

October 10, 2007

Completed

Last Updated

April 4, 2013

Status Verified

April 1, 2013

First QC Date

February 12, 2007

Last Update Submit

April 1, 2013

Conditions

Venous Thromboembolism

Keywords

Anti-thrombolytic direct Factor Xa inhibitor

Outcome Measures

Primary Outcomes (1)

Incidence of death OR symptomatic or non-symptomatic blood clots in the legs OR symptomatic blood clots in the lungs within 7 +/- 2 days following total knee replacement surgery.
symptomatic blood clots in the lungs within 7 +/- 2 days following total knee replacement surgery.

Secondary Outcomes (1)

Incidence of bleeding within 7 +/- 2 days following total knee replacement surgery.
Incidence of bleeding within 7 +/- 2 days following total knee replacement surgery

Interventions

GW813893DRUG

Eligibility Criteria

Age18 Years - 85 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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.

Contact the study team to confirm eligibility.