The purpose of this clinical research study is to assess efficacy and safety of 3 doses of apixaban 5 mg twice a day, 10 mg twice a day and 20 mg once daily versus conventional treatment with low molecular weight heparin or fondaparinux and vitamin K antagonist in the treatment of subjects with acute symptomatic deep-vein thrombosis.

Condition	Intervention	Phase
Deep-Vein Thrombosis	Drug: Apixaban	Phase II

Further study details as provided by Bristol-Myers Squibb:

Primary Outcomes: The composite of symptomatic recurrent venous thromboembolism (i.e., recurrent deep-vein thrombosis or fatal or non-fatal pulmonary embolism and deterioration of the thrombotic burden as assessed by repeat bilateral confir
Expected Total Enrollment:  520

Ages Eligible for Study:  18 Years   -   90 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Confirmed acute symptomatic DVT, i.e., proximal vein or extensive calf vein thrombosis, involving at least the upper third part of the deep calf veins (trifurcation area) without concomitant symptomatic PE.
• Written informed consent.

Exclusion Criteria:

• Women of Childbearing Potential
• Women who are pregnant or breastfeeding
• Women with a positive pregnancy test on enrollment or prior to study drug administration
• More than 24 hours pre-randomization treatment with therapeutic dosages of UFH, LMWH or fondaparinux or more than a single starting dose of VKA prior to randomization
• Uncontrolled hypertension: systolic blood pressure > 200 mm Hg or diastolic blood pressure > 110 mm Hg
• Creatinine clearance < 30 mL/min
• Impaired liver function (ALT > 3 x ULN; serum bilirubin > 1.5 ULN)
• Use of ASA >165 mg/day

Please refer to this study by ClinicalTrials.gov identifier  NCT00252005

BMS Call Center      1-866-892-1BMS  Ext. 327 
BMS Call Center Outside the US and Canada      1-215-347-4079  Ext. 327 

New Mexico
      Local Institution, Albuquerque,  New Mexico,  United States
North Carolina
      Local Institution, Chapel Hill,  North Carolina,  United States
Virginia
      Local Institution, Fredericksburg,  Virginia,  United States
Washington
      Local Institution, Seattle,  Washington,  United States
Australia, Australian Capital Territory
      Local Institution, Garran,  Australian Capital Territory,  Australia
Australia, New South Wales
      Local Institution, Kogarah,  New South Wales,  Australia
      Local Institution, Sydney,  New South Wales,  Australia
      Local Institution, Randwick,  New South Wales,  Australia
Australia, South Australia
      Local Institution, Bedford Park,  South Australia,  Australia
Australia, Victoria
      Local Institution, Box Hill,  Victoria,  Australia
      Local Institution, Clayton,  Victoria,  Australia
      Local Institution, Melbourne,  Victoria,  Australia
Australia, Western Australia
      Local Institution, Perth,  Western Australia,  Australia
Austria
      Local Institution, Graz,  Austria
      Local Institution, Vienna,  Austria
      Local Institution, Wien,  Austria
Czech Republic
      Local Institution, HRADEC KRALOVE,  Czech Republic
      Local Institution, Karlovy Vary,  Czech Republic
      Local Institution, Ostava,  Czech Republic
      Local Institution, Ostrava-Poruba,  Czech Republic
      Local Institution, Plzen,  Czech Republic
      Local Institution, Prague 5,  Czech Republic
      Local Institution, Praha,  Czech Republic
      Local Institution, Praha 4,  Czech Republic
      Local Institution, Usti nad Labem,  Czech Republic
France
      Local Institution, Angers,  France
      Local Institution, Brest Cedex,  France
      Local Institution, Clermont-Ferrand Cedex 01,  France
      Local Institution, Creteil,  France
      Local Institution, Montpellier,  France
      Local Institution, Paris,  France
      Local Institution, Saint-Etienne,  France
Israel
      Local Institution, Afula,  Israel
      Local Institution, Ashkelon,  Israel
      Local Institution, Haifa,  Israel
      Local Institution, Holon,  Israel
      Local Institution, Kfar Saba,  Israel
      Local Institution, Tel Aviv,  Israel
      Local Institution, Petach Tikva,  Israel
      Local Institution, Safed,  Israel
Italy
      Local Institution, Chieti,  Italy
      Local Institution, Milano,  Italy
      Local Institution, Padova,  Italy
      Local Institution, Pavia,  Italy
      Local Institution, Piacenza,  Italy
      Local Institution, Reggio Emilia,  Italy
      Local Institution, Treviso,  Italy
      Local Institution, Venezia,  Italy
Netherlands
      Local Institution, Amsterdam,  Netherlands
      Local Institution, Arnhem,  Netherlands
      Local Institution, Groningen,  Netherlands
      Local Institution, Hoofddorp,  Netherlands
      Local Institution, Maastricht,  Netherlands
      Local Institution, Zwolle,  Netherlands
Poland
      Local Institution, Bydgoszcz,  Poland
      Local Institution, Katowice,  Poland
      Local Institution, Krakow,  Poland
      Local Institution, Lublin,  Poland
      Local Institution, Poznan,  Poland
      Local Institution, Warszawa,  Poland
      Local Institution, Wroclaw,  Poland
South Africa, Free State
      Local Institution, Bloemfontein,  Free State,  South Africa
      Local Institution, Johannesburg,  Free State,  South Africa
South Africa, Gauteng
      Local Institution, Johannesburg,  Gauteng,  South Africa
      Local Institution, Lyttelton,  Gauteng,  South Africa
      Local Institution, Sunninghill,,  Gauteng,  South Africa
      Local Institution, Centurion,  Gauteng,  South Africa
South Africa, Western Cape
      Local Institution, Somerset West,  Western Cape,  South Africa
Sweden
      Local Institution, Boras,  Sweden
      Local Institution, Goteborg,  Sweden
      Local Institution, Halmstad,  Sweden
      Local Institution, Jonkoping,  Sweden
      Local Institution, Stockholm,  Sweden
      Local Institution, Vastervik,  Sweden

Study ID Numbers:  CV185-017
Last Updated:  December 20, 2005
Record first received:  November 9, 2005
ClinicalTrials.gov Identifier:  NCT00252005
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2006-01-10