Odiparcil For The Prevention Of Venous Thromboembolism

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.

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

Conditions

• Venous Thromboembolism
• Deep Vein Thrombosis
• Pulmonary Embolism

Study Type

Interventional

Study Design

Prevention, Randomized, Double-Blind, Active Control, Single Group Assignment, Safety/Efficacy Study

Further Details

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.

Study Start

September 2005

Eligibility & Criteria

• Ages Eligible for Study: 35 Years and above
• Genders Eligible for Study: Both

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.

Total Enrolment

915

Contact Details

• Box Hill, Victoria, 3128, Australia
• Windsor, Victoria, 3181, Australia
• Ringwood East, Victoria, 3185, Australia

Contact GlaxoSmithKline Australia for more details.