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

GlaxoSmithKline (GSK)

Status and phase: Withdrawn; Phase 2

Conditions: Venous Thromboembolism

Treatments: Drug: GW813893

Study type: Interventional

Funder types: Industry

Identifiers

NCT00541320

FTI102595

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 85 years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind