The purpose of this study is to gain additional safety information as well as to determine after the study drug has been given to patients who have undergone total hip replacement surgery, whether the study drug is effective in preventing late deep vein thrombosis (blood clots in legs) or pulmonary embolism (blood clots in lungs).

Condition	Treatment or Intervention	Phase
Thromboembolism Deep Vein Thrombosis Venous Thromboembolism Pulmonary Embolism	Drug: Investigational Thromboembolism Drug	Phase II

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

Criteria

Inclusion Criteria:

• Patients scheduled for primary elective unilateral total hip arthroplasty (i.e. first time the hip is being replaced on the operative side).
• Patients who have given written informed consent to participate in this study.

Exclusion Criteria:

• Patients with a contraindication to contrast venography
• Patients with an increased risk of bleeding
• Patients with a predefined risk for prothrombotic episodes or a history of thrombophilia
• Other inclusion or exclusion criteria to be determined by the physician and study sponsor.

California
      Stanford,  California,  94305,  United States
      Yuba City,  California,  95991,  United States
Colorado
      Aurora,  Colorado,  80045,  United States
      Golden,  Colorado,  80401,  United States
Florida
      Jacksonville,  Florida,  32216,  United States
      Delray Beach,  Florida,  33445,  United States
      St. Petersburg,  Florida,  33703,  United States
      Sarasota,  Florida,  34239,  United States
Illinois
      Gurnee,  Illinois,  60031,  United States
      Springfield,  Illinois,  62702,  United States
New Jersey
      Mercerville,  New Jersey,  08610,  United States
New York
      Buffalo,  New York,  14215,  United States
Oklahoma
      Oklahoma City,  Oklahoma,  73102,  United States
Pennsylvania
      Allentown,  Pennsylvania,  18102,  United States
      West Grove,  Pennsylvania,  19390,  United States
Texas
      Dallas,  Texas,  75231,  United States
      San Antonio,  Texas,  78233,  United States
Virginia
      Fredericksburg,  Virginia,  22401,  United States
Washington
      Seattle,  Washington,  98122,  United States
Australia, New South Wales
      Kogarah,  New South Wales,  2217,  Australia
Australia, Queensland
      Chermside,  Queensland,  4032,  Australia
Australia, South Australia
      Bedford Park,  South Australia,  5042,  Australia
Australia, Victoria
      Box Hill,  Victoria,  3128,  Australia
      Ringwood East,  Victoria,  3135,  Australia
      Geelong,  Victoria,  3220,  Australia
      Geelong,  Victoria,  3220,  Australia
Canada
      Quebec,  G1S 4L8,  Canada
Canada, Alberta
      Edmonton,  Alberta,  T6G 2R7,  Canada
Canada, British Columbia
      Kelowna,  British Columbia,  V1W 4V5,  Canada
      Vancouver,  British Columbia,  V6Z 2A5,  Canada
Canada, Manitoba
      Winnipeg,  Manitoba,  R3A 1M3,  Canada
Canada, Ontario
      Ottawa,  Ontario,  K1Y 1J8,  Canada
      Toronto,  Ontario,  M3C 3G8,  Canada
      Toronto,  Ontario,  M6R 1B5,  Canada
      Waterloo,  Ontario,  N2J 2V9,  Canada
      Sudbury,  Ontario,  P3E 6B4,  Canada
Canada, Quebec
      Sainte-Foy,  Quebec,  G1V 4G2,  Canada
      Fleurimont,  Quebec,  J1H 5N4,  Canada
      Saint-Jerome,  Quebec,  J7Z 5T3,  Canada

Study ID Numbers:  424323/025
Record last reviewed:  July 2004
Last Updated:  October 13, 2004
Record first received:  July 9, 2002
ClinicalTrials.gov Identifier:  NCT00041509
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08