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.
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
- Venous Thromboembolism
- Deep Vein Thrombosis
- Pulmonary Embolism
Prevention, Randomized, Double-Blind, Active Control, Single Group Assignment, Safety/Efficacy Study
Primary Outcome Measures:
- Total venous thromboembolism (VTE) event rate after 8 – 12 days of dosing.
Secondary Outcome 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.
Eligibility & Criteria
- Ages Eligible for Study: 35 Years and above
- Genders Eligible for Study: Both
- Women must be unable to have children.
- Will have a total knee replacement.
- 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.
- Box Hill, Victoria, 3128, Australia
- Windsor, Victoria, 3181, Australia
- Ringwood East, Victoria, 3185, Australia
Contact GlaxoSmithKline Australia for more details.