Official Title: “A Dose Ranging Trial for the Evaluation of the Safety, Tolerability and Efficacy of Odiparcil in the Prevention of Venous Thromboembolism Following Total Knee Replacement Surgery”

Odiparcil is being studied to determine if it can prevent blood clots from forming after a total knee replacement and also to prove that odiparcil is safe.

Study Type: Interventional

Study Design: Prevention, Randomized, Double-Blind, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: Odiparcil
• Drug: Warfarin
• Drug: Coumadin

Primary Measures

• Total venous thromboembolism (VTE) event rate after 8 - 12 days of dosing.
  • Time Frame: 12 Days
    

Secondary Measures

• Relative risk of VTE at Day 10. VTE event rate for odiparcil at Day 10. Pharmacodynamic effect as measured by anti-IIa activity at Days 1, 3, 5 and 10. Measurements of LFTs and major bleeding anytime during the trial.
  • Time Frame: 10 Days
    

Inclusion Criteria:

• Women must be unable to have children.
• Will have a total knee replacement.

Exclusion Criteria:

• Allergic to any X-ray dye.
• Allergies or reactions to warfarin or coumadin.
• Previous VTE (venous thromboembolism) or deep vein thrombosis (DVT).
• On anticoagulation therapy.
• Renal impairment.
• Participated in any clinical trial in the past 30 days.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 35 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: GlaxoSmithKline

Overall Clinical Trial Officials and Contacts

GSK Clinical Trials, MD Study Director GlaxoSmithKline  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00244725

Study ID Number: ITI101711

ClinicalTrials.gov Identifier: NCT00244725

Health Authority: United States: Food and Drug Administration