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Oral Direct Factor Xa Inhibitor BAY59-7939 in Patients With Acute Symptomatic Proximal Deep Vein Thrombosis(ODIXa-DVT)

This study has been completed.
Sponsor:
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT00839163
First received: February 6, 2009
Last updated: June 28, 2010
Last verified: June 2010
History of Changes
  Purpose

The purpose of this study is to compare the safety and efficacy of BAY59-7939 with the safety and efficacy of the licensed drug enoxaparin and a licensed oral vitamin K-antagonist and to find the optimal dose of BAY59-7939 for the anticipated phase III trials and for the future clinical use.


Condition Intervention Phase
Venous Thrombosis
Deep Vein Thrombosis
 Drug: Xarelto (Rivaroxaban, BAY59-7939)
Drug: Enoxaparin/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, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: ODIXa-DVTA Prospective, Randomized, Multinational, Multicenter, Partially Blinded, Parallel-group, Open-label Active Comparator Controlled Phase II Dose Finding and Proof of Principle Trial.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Response to treatment as determined by a Complete Compression Ultra sound (CCUS) [ Time Frame: 21 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response to treatment as determined by a Complete Compression Ultrasound (CCUS) and perfusion lung scan [ Time Frame: Day 21 ] [ Designated as safety issue: No ]
  • Response to treatment and residual vein diameter as assessed by Complete Compression Ultrasound (CCUS) [ Time Frame: Day 84 ] [ Designated as safety issue: No ]
  • Incidence of symptomatic and confirmed recurrence or extension of Deep Vein Thrombosis (DVT) [ Time Frame: Day 1-84 ] [ Designated as safety issue: No ]
  • Composite endpoint of symptomatic and confirmed recurrence and extension of Deep Vein Thrombosis (DVT) and symptomatic Pulmonary Embolism (PE) (nonfatal DVT and/or nonfatal PE) and deaths during the 3 months treatment period [ Time Frame: Day 1-84 ] [ Designated as safety issue: No ]
  • Incidence of symptomatic and confirmed recurrence and extension of Deep Vein Thrombosis (DVT) and symptomatic Pulmonary Embolism (PE) within 30 days after stop of treatment with study drug [ Time Frame: Day 1-114 ] [ Designated as safety issue: No ]

Enrollment: 636
Study Start Date: March 2004
Study Completion Date: October 2005
Primary Completion Date: October 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Xarelto (Rivaroxaban, BAY59-7939)
10 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).
Experimental: Arm 2 Drug: Xarelto (Rivaroxaban, BAY59-7939)
20 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).
Experimental: Arm 3 Drug: Xarelto (Rivaroxaban, BAY59-7939)
30 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).
Experimental: Arm 4 Drug: Xarelto (Rivaroxaban, BAY59-7939)
40 mg od main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).
Active Comparator: Arm 5 Drug: Enoxaparin/Vitamin K-Antagonist
Enoxaparin/Vitamin K-Antagonist main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84). Enoxaparin was to be administered 1mg/kg bid sc for about 5-7 days. It was to be discontinued when INR was within the therapeutic range 2-3 for 2 consecutive days

  Eligibility

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

Inclusion Criteria:

  • Patients with acute symptomatic proximal deep vein thrombosis

Exclusion Criteria:

  • Contraindication to comparator drugs
  • Symptomatic Pulmonary embolism
  • Conditions with increased bleeding risk
  • Unstable patients with reduced life expectancy
  • Severe renal impairment
  • Impaired liver function
  • Strong CYP 3A4 inhibitors
  • Platelet aggregation inhibitors (exception: ASA up to 500mg) therapy with anticoagulants or fibrinolytics
  • NSAIDs with half-life > 17 hours
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00839163

  Show 110 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Therapeutic Area Head, Bayer HealthCare AG
ClinicalTrials.gov Identifier: NCT00839163     History of Changes
Other Study ID Numbers: 11223, 2004-001083-43, ODIXa-DVT
Study First Received: February 6, 2009
Last Updated: June 28, 2010
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
Austria: Agency for Health and Food Safety
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
Canada: Health Canada
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Czech Republic: State Institute for Drug Control
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute of Pharmacy
Israel: Ministry of Health
Italy: The Italian Medicines Agency
Netherlands: Medicines Evaluation Board (MEB)
New Zealand: Medsafe
Peru: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
South Africa: Department of Health
Spain: Spanish Agency of Medicines
Sweden: Medical Products Agency
Switzerland: Swissmedic

Keywords provided by Bayer:
Embolism and Thrombosis
Pulmonary embolism
Embolism
Thrombosis

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

ClinicalTrials.gov processed this record on May 23, 2013