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...
Brief Summary
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: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Intervention(s) in this Clinical Trial
- Drug: Odiparcil
- Drug: Warfarin
- Drug: Coumadin
Outcome Measures for this Clinical Trial
Primary Measures
- Total venous thromboembolism (VTE) event rate after 8 - 12 days of dosing.
- Time Frame: 12 Days
- 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
- Time Frame: 10 Days
Criteria for Participation in this Clinical Trial
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
Clinical Trial Investigator Information
Lead Investigator: GlaxoSmithKline Industry
Overall Clinical Trial Officials and Contacts
GSK Clinical Trials Study Director GlaxoSmithKline
Additional Information
Information obtained from ClinicalTrials.gov on February 12, 2012
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00244725
Study ID Number: ITI101711
ClinicalTrials.gov Identifier: NCT00244725
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
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The URL of this page is:
http://clinicaltrialsfeeds.org/clinical-trials/show/NCT00244725
