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

Dose Ranging Trial for the Evaluation of the Safety and Efficacy of GW813893 in the Prophylaxis of Venous Thromboembolism Post Total Knee Replacement Surgery.

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00541320

Enrollment

Registered

2007-10-10

Start date

2007-02-28

Completion date

Unknown

Last updated

2013-04-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Venous Thromboembolism

Keywords

Anti-thrombolytic direct Factor Xa inhibitor

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.

Interventions

DRUGGW813893

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

18 Years to 85 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
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

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026