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

GlaxoSmithKline

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

DOUBLE

Conditions

Venous Thromboembolism

Interventions

GW813893DRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Locations (8)

GSK Clinical Trials Call Center

Birmingham, Alabama, United States

GSK Clinical Trials Call Center'

Phoenix, Arizona, United States

GSK Clinical Trials Call Center

Phoenix, Arizona, United States

GSK Clinical Trials Call Center

Yuba City, California, United States

Outcomes

Primary Outcomes

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.

Time frame: symptomatic blood clots in the lungs within 7 +/- 2 days following total knee replacement surgery.

Secondary Outcomes

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

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

Data from ClinicalTrials.gov

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