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

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GlaxoSmithKline
• Treatments: 2-(5-chlorothien-2-yl)-N-(1-(1-methyl-2-(morpholin-4-yl)-2-oxoethyl)-2-oxopyrrolidin-3-yl)ethenesulfonamide

Criteria

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.