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Once-daily Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Deep-vein Thrombosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00395772
Recruitment Status : Completed
First Posted : November 3, 2006
Last Update Posted : October 28, 2014
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):

Brief Summary:
The purpose of this study is to determine the optimal dose of BAY 59-7939 and to compare the safety and effectiveness of this new drug with the standard way of treatment of deep vein thrombosis (heparin infusion plus one of the vitamin K antagonists), taking into account new events of thrombosis and pulmonary embolism and bleeding risk.

Condition or disease Intervention/treatment Phase
Venous Thromboembolism Drug: Xarelto (Rivaroxaban, BAY59-7939) Drug: (LMW) Heparin + Vitamin K Antagonist Phase 2

Detailed Description:
Within the U.S., Johnson & Johnson is sponsor.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 543 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Once-daily Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Deep-vein Thrombosis The Einstein-DVT Dose-finding Study. A Phase II Evaluation.
Study Start Date : December 2004
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Rivaroxaban

Arm Intervention/treatment
Active Comparator: Arm 4 Drug: (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

Experimental: Arm 1 Drug: Xarelto (Rivaroxaban, BAY59-7939)
BAY59-7939 20 mg once daily (od) for 12 weeks

Experimental: Arm 2 Drug: Xarelto (Rivaroxaban, BAY59-7939)
BAY59-7939 30 mg od for 12 weeks

Experimental: Arm 3 Drug: Xarelto (Rivaroxaban, BAY59-7939)
BAY59-7939 40 mg od for 12 weeks

Primary Outcome Measures :
  1. The primary efficacy endpoint was the composite of symptomatic recurrent DVT or symptomatic fatal and non-fatal PE at 12 weeks and deterioration in thrombotic burden, as assessed by CUS and PLS, at baseline and at 12 weeks. [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. The principal safety outcome is all clinically relevant bleeding (i.e. major bleeding and clinically relevant non-major bleeding) within 12 weeks. [ Time Frame: 12 weeks ]
  2. The separate components of the primary efficacy outcome at 12 weeks. [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

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

Exclusion Criteria:

  • Legal lower age limitations (country specific)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00395772

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Sponsors and Collaborators
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
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Study Director: Bayer Study Director Bayer

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Bayer Identifier: NCT00395772     History of Changes
Other Study ID Numbers: 11528
EudraCT: 2004-002171-16
First Posted: November 3, 2006    Key Record Dates
Last Update Posted: October 28, 2014
Last Verified: October 2014
Keywords provided by Bayer:
Treatment of venous thromboembolism
Additional relevant MeSH terms:
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Venous Thromboembolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Vitamin K
Factor Xa Inhibitors
Growth Substances
Physiological Effects of Drugs
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Antifibrinolytic Agents