check_circleStudy Completed
Venous Thromboembolism
Bayer Identifier:
10945
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
An Oral, Direct Factor Xa Inhibitor, BAY59-7939, for Prophylaxis Against Venous Thromboembolism after Total Knee Replacement: a Dose-Ranging Study
Trial purpose
The study drug, BAY59-7939, is a new drug currently being tested in the prevention of VTE. It directly inhibits factor Xa, a blood component in the pathway which leads to coagulation (clotting of blood cells). It is available as a tablet. The purpose of this study is to compare the safety and efficacy of BAY59-7939 with the safety and efficacy of the licensed drug Enoxaparin. Enoxaparin, a so-called low molecular heparin, is approved and widely used in the area of thromboprophylaxis and will be given once daily subcutaneously. In this study 4 different doses of the investigational drug BAY59-7939 will be tested in comparison to Enoxaparin. You will receive during the study either one of the following BAY59-7939 treatments or Enoxaparin. The following doses of BAY59-7939 will be tested: Dose I ; Dose II, Dose III, Dose IV. This study will run for approximately 7 months in a number of countries. In total, up to 600 patients may participate in this study.
Key Participants Requirements
Sex
BothAge
18 YearsTrial summary
Enrollment Goal
613Trial Dates
February 2004 - November 2004Phase
Phase 2Could I Receive a placebo
NoProducts
Xarelto (Rivaroxaban, BAY59-7939)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Birmingham, 35205, United States | |
Completed | Welland, L3B 4W6, Canada | |
Completed | Phoenix, 85023, United States | |
Completed | Red Deer, T4N 6V7, Canada | |
Completed | Sudbury, P3E 6C3, Canada | |
Completed | Sarasota, 34239, United States | |
Completed | Winnipeg, R3A 1M3, Canada | |
Completed | Lubbock, 79410, United States | |
Completed | Quebec, G1J 1Z4, Canada | |
Completed | Decatur, 30033, United States | |
Completed | Ottawa, K1H 8L6, Canada | |
Completed | Cincinnati, 45219, United States | |
Completed | Montreal, H3G 1A4, Canada | |
Completed | Aurora, 80011-6798, United States | |
Completed | St. Catherines, L2R 5K3, Canada | |
Completed | Kelowna, V1Y 1T2, Canada | |
Completed | Vancouver, V6Z 1Y6, Canada | |
Completed | Toronto, M3M 2G2, Canada | |
Completed | St. Petersburg, 33703, United States | |
Completed | Barrie, L4M 6M2, Canada | |
Completed | Charlottetown, C1A 1L2, Canada | |
Completed | Richmond Hill, L4C 4Z3, Canada | |
Completed | La Mesa, 91942, United States | |
Completed | Palm Beach Gardens, 33410, United States | |
Completed | Torrance, 90502-2004, United States | |
Completed | Oshawa, L1G 2B9, Canada | |
Completed | Peterborough, K9J 7H8, Canada | |
Completed | Tucson, 85712, United States | |
Completed | Jacksonville, 32216, United States | |
Completed | Niagara Falls, L2G 5X8, Canada | |
Completed | Dallas, 75231, United States | |
Completed | Aurora, 80012, United States | |
Completed | Edmonton, T6G 2B7, Canada | |
Completed | Thunder Bay, P7B 6V4, Canada | |
Completed | Kitchener, N2G 1G3, Canada | |
Completed | Fredericton, E3B 5N5, Canada | |
Withdrawn | Chatham, N7M 4T1, Canada | |
Withdrawn | Lexington, 40509, United States | |
Withdrawn | La Jolla, 92037, United States | |
Terminated | Guelph, N1E 6L9, Canada | |
Withdrawn | Scottsdale, 85260, United States | |
Withdrawn | Windsor, N8W 1E6, Canada | |
Withdrawn | Poway, 92064, United States | |
Withdrawn | Saint John, E2L 4L2, Canada | |
Withdrawn | Toronto, M6R 1B5, Canada | |
Withdrawn | San Antonio, 78233, United States | |
Withdrawn | Toronto, M4C 3E7, Canada | |
Withdrawn | St. Jerome, J7Z 5T3, Canada | |
Withdrawn | Hamilton, L8V 1C3, Canada | |
Withdrawn | Waterloo, N2J 1C4, Canada | |
Withdrawn | St. Catharines, L2R 5K3, Canada |
Primary Outcome
- Composite endpoints of Deep vein Thrombosis (proximal and/or distal),non fatal PE and death from all causesdate_rangeTime Frame:5-9 days after surgery or earlier in case of symptoms indicating deep vein Thrombosis.enhanced_encryptionYesSafety Issue:
Secondary Outcome
- Incidence of DVTs (total, proximal, distal)date_rangeTime Frame:Day 6-10enhanced_encryptionYesSafety Issue:
- Incidence of symptomatic VTEsdate_rangeTime Frame:Day 6-10enhanced_encryptionYesSafety Issue:
- The composite endpoint that results from the primary endpoint by substituting VTE related death for all deathsdate_rangeTime Frame:Day 6-10enhanced_encryptionYesSafety Issue:
- Incidence of symptomatic VTEs (total, PE, DVT)date_rangeTime Frame:Day 6-10enhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
PreventionAllocation
RandomizedBlinding
Double BlindAssignment
Parallel AssignmentTrial Arms
6