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

This study has been withdrawn prior to enrollment.
(No longer viable)
Information provided by:
GlaxoSmithKline Identifier:
First received: February 12, 2007
Last updated: April 1, 2013
Last verified: April 2013
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.

Condition Intervention Phase
Venous Thromboembolism
Drug: GW813893
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Prevention
Official Title: Dose Ranging Trial for the Evaluation of the Safety and Efficacy of GW813893 in the Prophylaxis of Venous Thromboembolism Post Total Knee Replacement Surgery.

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: February 2007

Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00541320

United States, Alabama
GSK Clinical Trials Call Center
Birmingham, Alabama, United States, 35209
United States, Arizona
GSK Clinical Trials Call Center`
Phoenix, Arizona, United States, 85023
GSK Clinical Trials Call Center
Phoenix, Arizona, United States, 85023
United States, California
GSK Clinical Trials Call Center
Yuba City, California, United States, 95991
United States, Florida
GSK Clinical Trials Call Center
St. Petersburg, Florida, United States, 33703
United States, Georgia
GSK Clinical Trials Call Center
Decatur, Georgia, United States, 30032
United States, South Carolina
GSK Clinical Trials Call Center
Charleston, South Carolina, United States, 29414
United States, Texas
GSK Clinical Trials Call Center
San Antonio, Texas, United States, 78217
Sponsors and Collaborators
Study Director: GSK Clinical Trials, MD GlaxoSmithKline
  More Information Identifier: NCT00541320     History of Changes
Other Study ID Numbers: FTI102595
Study First Received: February 12, 2007
Last Updated: April 1, 2013

Keywords provided by GlaxoSmithKline:
Anti-thrombolytic direct Factor Xa inhibitor

Additional relevant MeSH terms:
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Factor Xa Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants processed this record on May 25, 2017