Patients who have deep vein thrombosis (blood clot in the leg) will be treated in this study. The purpose of the study is to compare the safety and effectiveness of a new injectable anticoagulant (blood thinning) drug administered once each week, SanOrg34006, with the standard way of treating deep vein thrombosis. The standard treatment includes injections or infusions of an anticoagulant drug (Unfractionated Heparin or low molecular weight heparin) for about a week, followed by vitamin K antagonist (VKA) anticoagulant tablets (warfarin or acenocoumarol) which are taken by mouth. Eligible patients will be assigned to treatment with either SanOrg34006 or the combination of Unfractionated Heparin or low molecular weight heparin plus a VKA (warfarin or acenocoumarol) by random chance. Treatment will be known to both patients and their doctors.

Condition	Treatment or Intervention	Phase
Deep Vein Thrombosis	Drug: SanOrg34006  Drug: LMW heparin  Drug: Unfractionated heparin  Drug: Vitamin K antagonist (VKA)	Phase III

Further Study Details: 

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Confirmed acute symptomatic DVT
• Written informed consent

Exclusion Criteria:

• Legal lower age limitations
• Patients with symptomatic pulmonary embolism
• Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT
• Other indication for VKA than DVT
• More than 36 hours before the treatment with therapeutic dosages of low molecular weight heparin or initiation of VKA treatment prior to randomization
• Participation in another pharmacotherapeutic study within the prior 30 days
• Creatinine clearance <10mL/min, severe hepatic disease or bacterial endocarditis
• Life expectancy <3 Months
• Active bleeding or high risk for bleeding
• Uncontrolled hypertension: systolic blood pressure >180 mm Hg and diastolic blood pressure >110 mm Hg.
• Pregnancy or childbearing potential without proper contraceptive measures
• Any other contraindication listed in the labeling of warfarin, acenocoumarol, unfractionated heparin (UFH), enoxaparin, or tinzaparin

Colorado
      University of Colorado Health Sciences Center, Denver,  Colorado,  80129,  United States
Florida
      MIMA Century Research Associates, Melbourne,  Florida,  32901,  United States
      Jackson Cardio-Vascular Clinic, Jacksonville,  Florida,  32216,  United States
Georgia
      Medical College of Georgia, Augusta,  Georgia,  30912,  United States
      DeKalb Medical Center, Decatur,  Georgia,  30033-6136,  United States
Illinois
      Evanston Northwestern Healthcare, Evanston,  Illinois,  60201,  United States
      Loyola University of Chicago, Maywood,  Illinois,  60513,  United States
      Northwestern University, Chicago,  Illinois,  60611,  United States
Kansas
      Consultants in Pulmonary Medicine, Olathe,  Kansas,  66061,  United States
Massachusetts
      Boston Medical Center, Boston,  Massachusetts,  02118,  United States
Michigan
      St. Joseph Mercy - Oakland Research Center, Pontiac,  Michigan,  48341,  United States
New Mexico
      Lovelace Health Systems, Albuquerque,  New Mexico,  87108,  United States
New York
      University of Rochester Medical Center, Rochester,  New York,  14642,  United States
      North Shore University Hospital, Manhasset,  New York,  11030,  United States
North Dakota
      Health System Research Center, Grand Forks,  North Dakota,  58201,  United States
Oklahoma
      University of Oklahoma HSC, Oklahoma City,  Oklahoma,  73104,  United States
Pennsylvania
      Lehigh Valley Hospital, Allentown,  Pennsylvania,  18103,  United States
Texas
      Scott and White Memorial Hospital & Clinic, Temple,  Texas,  76508,  United States
      James Muntz, Houston,  Texas,  77030,  United States
Virginia
      McGuire VAMC, Richmond,  Virginia,  23249,  United States
      Pulmonary Associates, Fredericksburg,  Virginia,  22401,  United States
      Inova Alexandria Hospital, Alexandria,  Virginia,  22304,  United States
Washington
      William Dittman, Spokane,  Washington,  99203,  United States
      Swedish Medical Center, Seattle,  Washington,  98122,  United States

Study ID Numbers:  EFC3491/64717
Record last reviewed:  February 2005
Last Updated:  February 4, 2005
Record first received:  August 11, 2003
ClinicalTrials.gov Identifier:  NCT00067093
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-04-08