Oral Direct Factor Xa-inhibitor Apixaban in Patients With Acute Symptomatic Deep-vein Thrombosis-The Botticelli DVT Study
NCT ID: NCT00252005
Last Updated: 2010-03-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
520 participants
INTERVENTIONAL
2005-11-30
2007-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Interventions
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Apixaban
Eligibility Criteria
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Inclusion Criteria
2. 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.
3. Women and men, ages 18 (or legal age of consent) to 90. Women of childbearing potential (WOCBP) must be using an adequate method of contraception to avoid pregnancy throughout the study and for up to 1 week after the study in such a manner that the risk of pregnancy is minimized.
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
2. Women with a positive pregnancy test on enrollment or prior to study drug administration.
3. More than 24 hours pre-randomization treatment with therapeutic dosages of unfractionated heparin (UFH), low molecular weight heparin (LMWH) or fondaparinux or more than a single starting dose of vitamin K antagonist (VKA) prior to randomization.
4. Uncontrolled hypertension: systolic blood pressure \> 200 mm Hg or diastolic blood pressure \> 110 mm Hg.
5. Creatinine clearance \< 30 mL/min
6. Impaired liver function (ALT \> 3 x ULN)
7. Use of ASA \> 165 mg/day
8. WOCBP who are unwilling or unable to use an acceptable method of birth control to avoid pregnancy for the entire study period and for up to 1 week after the study.
9. Azole antifungals (e.g., ketoconazole), HIV protease inhibitors (e.g., ritonavir) and macrolide antibiotics (e.g., erythromycin).
NOTE: topical azole antifungal agents are permitted.
18 Years
90 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Locations
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Local Institution
Albuquerque, New Mexico, United States
Local Institution
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
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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
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Holon, , Israel
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Jerusalem, , Israel
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Kfar Saba, , Israel
Local Institution
Petah Tikva, , Israel
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Safed, , Israel
Local Institution
Tel Aviv, , Israel
Local Institution
Chieti, , Italy
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Milan, , Italy
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Padua, , Italy
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Pavia, , Italy
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Piacenza, , Italy
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Reggio Emilia, , Italy
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Treviso, , Italy
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Venezia, , Italy
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Amsterdam, , Netherlands
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Arnhem, , Netherlands
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Groningen, , Netherlands
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Hoofddorp, , Netherlands
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Maastricht, , Netherlands
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Zwolle, , Netherlands
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Bydgoszcz, , Poland
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Katowice, , Poland
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Krakow, , Poland
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Lublin, , Poland
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Poznan, , Poland
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Warsaw, , Poland
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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
Countries
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Other Identifiers
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CV185-017
Identifier Type: -
Identifier Source: org_study_id
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