Once-daily Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Deep-vein Thrombosis
NCT ID: NCT00395772
Last Updated: 2014-10-28
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
543 participants
INTERVENTIONAL
2004-12-31
2005-12-31
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
Study Groups
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Arm 4
(LMW) Heparin + Vitamin K Antagonist
Low Molecular Weight (LMW) Heparin + Vitamin K Antagonist (VKA) for 5 days, then VKA only for the rest of 12 weeks
Arm 1
Xarelto (Rivaroxaban, BAY59-7939)
BAY59-7939 20 mg once daily (od) for 12 weeks
Arm 2
Xarelto (Rivaroxaban, BAY59-7939)
BAY59-7939 30 mg od for 12 weeks
Arm 3
Xarelto (Rivaroxaban, BAY59-7939)
BAY59-7939 40 mg od for 12 weeks
Interventions
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Xarelto (Rivaroxaban, BAY59-7939)
BAY59-7939 20 mg once daily (od) for 12 weeks
Xarelto (Rivaroxaban, BAY59-7939)
BAY59-7939 30 mg od for 12 weeks
Xarelto (Rivaroxaban, BAY59-7939)
BAY59-7939 40 mg od for 12 weeks
(LMW) Heparin + Vitamin K Antagonist
Low Molecular Weight (LMW) Heparin + Vitamin K Antagonist (VKA) for 5 days, then VKA only for the rest of 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Written informed consent
Exclusion Criteria
* Thrombectomy, insertion of a caval filter, or use of a fibrinolytic agent to treat the current episode of DVT
* Other indication for VKA than PE/DVT
* More than 36 hours pre-randomization treatment with therapeutic dosages of (LMW) heparin or more than a single dose of VKA prior to randomization
* Participation in another pharmacotherapeutic study within the prior 30 days
* Creatinine clearance \< 30 mL/min, impaired liver function (transaminases \> 2 x ULN), or bacterial endocarditis
* Life expectancy \< 3 months
* Active bleeding or high risk for bleeding contraindicating treatment with (LMW) heparin
* Uncontrolled hypertension: systolic blood pressure \> 200 mmHg and diastolic blood pressure \> 110 mmHg
* Pregnancy or childbearing potential without proper contraceptive measures
* Any other contraindication listed in the labeling of warfarin, acenocoumarol, phenprocoumon, fluindione, UFH, enoxaparin, or tinzaparin
* Systemic treatment with azole compounds or other strong CYP3A4 inhibitors (e.g. ketoconazole, fluconazol, itraconazole, HIV protease inhibitors) within 4 days prior to randomization and during the study
18 Years
ALL
No
Sponsors
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Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
INDUSTRY
Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Albuquerque, New Mexico, United States
Albuquerque, New Mexico, United States
Chapel Hill, North Carolina, United States
Fredericksburg, Virginia, United States
Seattle, Washington, United States
Canberra, Australian Capital Territory, Australia
Sydney, New South Wales, Australia
Sydney, New South Wales, Australia
Brisbane, Queensland, Australia
Melbourne, Victoria, Australia
Melbourne, Victoria, Australia
Melbourne, Victoria, Australia
Curitiba, Paraná, Brazil
Porto Alegre, Rio Grande do Sul, Brazil
São Paulo, São Paulo, Brazil
Sorocaba, São Paulo, Brazil
Edmonton, Alberta, Canada
Halifax, Nova Scotia, Canada
London, Ontario, Canada
Hradec Králové, , Czechia
Karlovy Vary, , Czechia
Ostrava, , Czechia
Pilsen, , Czechia
Prague, , Czechia
Prague, , Czechia
Ústí nad Labem, , Czechia
Aarhus, , Denmark
Brædstrup, , Denmark
Frederiksberg, , Denmark
Brest, , France
Grenoble, , France
Montpellier, , France
Paris, , France
Paris, , France
Saint-Etienne, , France
Valenciennes, , France
Afula, , Israel
Ashkelon, , Israel
Haifa, , Israel
Haifa, , Israel
Haifa, , Israel
Holon, , Israel
Kfar Saba, , Israel
Petah Tikva, , Israel
Safed, , Israel
Tel Aviv, , Israel
Tel Litwinsky, , Israel
Milan, , Italy
Milan, , Italy
Milan, , Italy
Padua, , Italy
Pavia, , Italy
Reggio Emilia, , Italy
Venezia, , Italy
Amersfoort, , Netherlands
Amsterdam, , Netherlands
Amsterdam, , Netherlands
Arnhem, , Netherlands
Groningen, , Netherlands
Hoofddorp, , Netherlands
Maastricht, , Netherlands
Sittard-geleen, , Netherlands
Zwolle, , Netherlands
Warsaw, Poland, Poland
Bydgoszcz, , Poland
Warsaw, , Poland
Wroclaw, , Poland
Wroclaw, , Poland
Johannesburg, Gauteng, South Africa
Johannesburg, Gauteng, South Africa
Johannesburg, Gauteng, South Africa
Johannesburg, Gauteng, South Africa
Johannesburg, Gauteng, South Africa
Gothenburg, , Sweden
Jönköping, , Sweden
Stockholm, , Sweden
Stockholm, , Sweden
Västervik, , Sweden
Countries
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References
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Buller HR, Lensing AW, Prins MH, Agnelli G, Cohen A, Gallus AS, Misselwitz F, Raskob G, Schellong S, Segers A; Einstein-DVT Dose-Ranging Study investigators. A dose-ranging study evaluating once-daily oral administration of the factor Xa inhibitor rivaroxaban in the treatment of patients with acute symptomatic deep vein thrombosis: the Einstein-DVT Dose-Ranging Study. Blood. 2008 Sep 15;112(6):2242-7. doi: 10.1182/blood-2008-05-160143. Epub 2008 Jul 11.
Related Links
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Click here to find information about studies related to Bayer Healthcare products conducted in Europe
Other Identifiers
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EudraCT: 2004-002171-16
Identifier Type: -
Identifier Source: secondary_id
11528
Identifier Type: -
Identifier Source: org_study_id
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