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

This study has been completed.
Sponsor:
Collaborator:
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00395772
First received: November 2, 2006
Last updated: October 10, 2013
Last verified: October 2013
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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.

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • The separate components of the primary efficacy outcome at 12 weeks. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 543
Study Start Date: December 2004
Study Completion Date: December 2005
Arms Assigned Interventions
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

Detailed Description:

Within the U.S., Johnson & Johnson is sponsor.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395772

  Show 78 Study Locations
Sponsors and Collaborators
Bayer
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
No publications provided by Bayer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00395772     History of Changes
Other Study ID Numbers: 11528, EudraCT: 2004-002171-16
Study First Received: November 2, 2006
Last Updated: October 10, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Treatment of venous thromboembolism

Additional relevant MeSH terms:
Thromboembolism
Thrombosis
Venous Thrombosis
Venous Thromboembolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Heparin
Vitamin K
Vitamins
Anticoagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cardiovascular Agents
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antifibrinolytic Agents
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on July 24, 2014