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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Apixaban | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | ||
| compression ultrasound and perfusion lung scan. |
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Inclusion Criteria:
WOCBP include any female who has experienced menarche and who has not undergone successful surgical sterilization (hysterectomy, bilateral tubal ligation or bilateral oophorectomy) or is not postmenopausal [defined as amenorrhea for 12 consecutive months; or women on hormone replacement therapy (HRT) with documented serum follicle stimulating hormone (FSH) level > 35mIU/mL]. Even women who are using oral, implanted or, injectable contraceptive hormones or mechanical products such as an intrauterine device or barrier methods (diaphragm, condoms, spermicides) to prevent pregnancy or practicing abstinence or where partner is sterile (e.g., vasectomy), should be considered to be of child bearing potential. WOCBP must have negative serum or urine pregnancy test (minimum sensitivity 25IU/L or equivalent units of HCG) within 24 hours prior to the start of study medication.
Exclusion Criteria:
NOTE: topical azole antifungal agents are permitted.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Local Institution | Albuquerque | New Mexico | United States | |||
| Local Institution |
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| Chapel Hill |
| North Carolina |
| United States |
| Local Institution | San Antonio | Texas | United States |
| Local Institution | Fredericksburg | Virginia | United States |
| Local Institution | Seattle | Washington | United States |
| Local Institution | Garran | Australian Capital Territory | Australia |
| Local Institution | Caringbah | New South Wales | Australia |
| Local Institution | Kogarah | New South Wales | Australia |
| Local Institution | Randwick | New South Wales | Australia |
| Local Institution | Bedford Park | South Australia | Australia |
| Local Institution | Box Hill | Victoria | Australia |
| Local Institution | Clayton | Victoria | Australia |
| Local Institution | Melbourne | Victoria | Australia |
| Local Institution | Perth | Western Australia | Australia |
| Local Institution | Graz | Austria |
| Local Institution | Vienna | Austria |
| Local Institution | Hradec Králové | Czechia |
| Local Institution | Karlovy Vary | Czechia |
| Local Institution | Ostrava | Czechia |
| Local Institution | Ostrava Poruba | Czechia |
| Local Institution | Pilsen | Czechia |
| Local Institution | Prague | Czechia |
| Local Institution | Ústí nad Labem | Czechia |
| Local Institution | Angers | France |
| Local Institution | Brest | France |
| Local Institution | Clermont-Ferrand | France |
| Local Institution | Créteil | France |
| Local Institution | Limoges | France |
| Local Institution | Montpellier | France |
| Local Institution | Paris | France |
| Local Institution | Saint-Etienne | France |
| Local Institution | Afula | Israel |
| Local Institution | Ashkelon | Israel |
| Local Institution | Haifa | Israel |
| Local Institution | Holon | Israel |
| Local Institution | Jerusalem | Israel |
| Local Institution | Kfar Saba | Israel |
| Local Institution | Petah Tikva | Israel |
| Local Institution | Safed | Israel |
| Local Institution | Tel Aviv | Israel |
| Local Institution | Chieti | Italy |
| Local Institution | Milan | 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 |
| Local Institution | Amsterdam | Netherlands |
| Local Institution | Arnhem | Netherlands |
| Local Institution | Groningen | Netherlands |
| Local Institution | Hoofddorp | Netherlands |
| Local Institution | Maastricht | Netherlands |
| Local Institution | Zwolle | Netherlands |
| Local Institution | Bydgoszcz | Poland |
| Local Institution | Katowice | Poland |
| Local Institution | Krakow | Poland |
| Local Institution | Lublin | Poland |
| Local Institution | Poznan | Poland |
| Local Institution | Warsaw | Poland |
| Local Institution | Wroclaw | Poland |
| Local Institution | Bloemfontein | Free State | South Africa |
| Local Institution | Centurion | Gauteng | South Africa |
| Local Institution | Johannesburg | Gauteng | South Africa |
| Local Institution | Sunninghill | Gauteng | South Africa |
| Local Institution | Somerset West | Western Cape | South Africa |
| Local Institution | Borås | Sweden |
| Local Institution | Gothenburg | Sweden |
| Local Institution | Halmstad | Sweden |
| Local Institution | Jönköping | Sweden |
| Local Institution | Stockholm | Sweden |
| Local Institution | Västervik | Sweden |
| ID | Term |
|---|---|
| D020246 | Venous Thrombosis |
| ID | Term |
|---|---|
| D013927 | Thrombosis |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| C522181 | apixaban |
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