Pulmonary Embolism Clinical Trial
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.
| Status | Completed |
| Enrollment | 961 |
| Est. completion date | September 2006 |
| Est. primary completion date | September 2006 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 35 Years and older |
| Eligibility |
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. |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double-Blind, Primary Purpose: Prevention
| Country | Name | City | State |
|---|---|---|---|
| Australia | GSK Investigational Site | Box Hill | Victoria |
| Australia | GSK Investigational Site | Camperdown | New South Wales |
| Australia | GSK Investigational Site | Clayton | Victoria |
| Australia | GSK Investigational Site | Geelong | Victoria |
| Australia | GSK Investigational Site | Southport | Queensland |
| Australia | GSK Investigational Site | Windsor | Victoria |
| Brazil | GSK Investigational Site | Porto Alegre | Rio Grande Do Sul |
| Brazil | GSK Investigational Site | Porto Alegre | Rio Grande Do Sul |
| Canada | GSK Investigational Site | Ajax | Ontario |
| Canada | GSK Investigational Site | Charlottetown | Prince Edward Island |
| Canada | GSK Investigational Site | Don Mills | Ontario |
| Canada | GSK Investigational Site | Montreal | Quebec |
| Canada | GSK Investigational Site | Newmarket | Ontario |
| Canada | GSK Investigational Site | North York | Ontario |
| Canada | GSK Investigational Site | Oshawa | Ontario |
| Canada | GSK Investigational Site | Québec | Quebec |
| Canada | GSK Investigational Site | Sainte Jerome | Quebec |
| Canada | GSK Investigational Site | Scarborough | Ontario |
| Canada | GSK Investigational Site | Waterloo | Ontario |
| Canada | GSK Investigational Site | Winnipeg | Manitoba |
| India | GSK Investigational Site | Chennai | |
| India | GSK Investigational Site | Secunderabad | |
| Israel | GSK Investigational Site | Tel-Aviv | |
| Latvia | GSK Investigational Site | Riga | |
| Latvia | GSK Investigational Site | Riga | |
| Lithuania | GSK Investigational Site | Klaipeda | |
| Lithuania | GSK Investigational Site | Vilnius | |
| Poland | GSK Investigational Site | Krakow | |
| Poland | GSK Investigational Site | Wroclaw | |
| Russian Federation | GSK Investigational Site | Irkutsk | |
| Russian Federation | GSK Investigational Site | Kurgan | |
| Russian Federation | GSK Investigational Site | Moscow | |
| Russian Federation | GSK Investigational Site | Mosocow | |
| Russian Federation | GSK Investigational Site | Mosocow | |
| South Africa | GSK Investigational Site | Centurion | |
| South Africa | GSK Investigational Site | Pretoria | |
| South Africa | GSK Investigational Site | Pretoria | Gauteng |
| Ukraine | GSK Investigational Site | Cherkasy | |
| Ukraine | GSK Investigational Site | Dnepropetrovsk | |
| Ukraine | GSK Investigational Site | Kyiv | |
| Ukraine | GSK Investigational Site | Kyiv | |
| Ukraine | GSK Investigational Site | Vinnitsa | |
| United Kingdom | GSK Investigational Site | Birmingham | West Midlands |
| United Kingdom | GSK Investigational Site | Bournmouth | |
| United Kingdom | GSK Investigational Site | Fife | |
| United Kingdom | GSK Investigational Site | London | |
| United Kingdom | GSK Investigational Site | Wigan | |
| United States | GSK Investigational Site | Allentown | Pennsylvania |
| United States | GSK Investigational Site | Altoona | Pennsylvania |
| United States | GSK Investigational Site | Baltimore | Maryland |
| United States | GSK Investigational Site | Baton Rouge | Louisiana |
| United States | GSK Investigational Site | Birmingham | Alabama |
| United States | GSK Investigational Site | Boise | Idaho |
| United States | GSK Investigational Site | Camp Hill | Pennsylvania |
| United States | GSK Investigational Site | Charlotte | North Carolina |
| United States | GSK Investigational Site | Clearwater | Florida |
| United States | GSK Investigational Site | Dallas | Texas |
| United States | GSK Investigational Site | Decatur | Georgia |
| United States | GSK Investigational Site | Deland | Florida |
| United States | GSK Investigational Site | Hershey | Pennsylvania |
| United States | GSK Investigational Site | Lexington | Kentucky |
| United States | GSK Investigational Site | Little Rock | Arkansas |
| United States | GSK Investigational Site | Lubbock | Texas |
| United States | GSK Investigational Site | Marshfield | Wisconsin |
| United States | GSK Investigational Site | Mineola | New York |
| United States | GSK Investigational Site | Mobile | Alabama |
| United States | GSK Investigational Site | Norfolk | Virginia |
| United States | GSK Investigational Site | Philadelphia | Pennsylvania |
| United States | GSK Investigational Site | Phoenix | Arizona |
| United States | GSK Investigational Site | Richmond | Virginia |
| United States | GSK Investigational Site | Sacramento | California |
| United States | GSK Investigational Site | San Antonio | Texas |
| United States | GSK Investigational Site | San Antonio | Texas |
| United States | GSK Investigational Site | Sarasota | Florida |
| United States | GSK Investigational Site | Sarsota | Florida |
| United States | GSK Investigational Site | St. Petersburg | Florida |
| United States | GSK Investigational Site | Torrance | California |
| United States | GSK Investigational Site | Warren | Michigan |
| United States | GSK Investigational Site | Yuba City | California |
| Lead Sponsor | Collaborator |
|---|---|
| GlaxoSmithKline |
United States, Australia, Brazil, Canada, India, Israel, Latvia, Lithuania, Poland, Russian Federation, South Africa, Ukraine, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Total venous thromboembolism (VTE) event rate after 8 - 12 days of dosing. | 12 Days | ||
| Secondary | 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. | 10 Days |
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