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

Sponsored by:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00839163

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
Deep Vein Thrombosis	Drug: Rivaroxaban (BAY59-7939) Drug: Enoxaparin/Vitamin K-Antagonist	Phase II

MedlinePlus related topics: Deep Vein Thrombosis Pulmonary Embolism Ultrasound

Drug Information available for: Vitamin K Rivaroxaban Enoxaparin Sodium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	ODIXa-DVT A Prospective, Randomized, Multinational, Multicenter, Partially Blinded, Parallel-Group, Open-Label Active Comparator Controlled Phase II Dose Finding and Proof of Principle Trial.

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 Pulmonary embolism (PE) and deaths during the 3 m 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:	July 2005 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Arm 1: Experimental	Drug: 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).
Arm 2: Experimental	Drug: 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).
Arm 3: Experimental	Drug: 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).
Arm 4: Experimental	Drug: 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).
Arm 5: Active Comparator	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:

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No publications provided

Responsible Party:	Bayer HealthCare AG ( Therapeutic Area Head )
Study ID Numbers:	11223, 2004-001083-43, ODIXa-DVT
Study First Received:	February 6, 2009
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00839163 History of Changes
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
Venous Thrombosis
Thrombosis

Study placed in the following topic categories:

Anticoagulants
Pulmonary Embolism
Vascular Diseases
Fibrinolytic Agents
Trace Elements
Cardiovascular Agents
Hemostatics
Thrombosis
Enoxaparin
Signs and Symptoms

Fibrin Modulating Agents
Embolism and Thrombosis
Antiplasmin
Antifibrinolytic Agents
Embolism
Vitamins
Vitamin K
Venous Thrombosis
Micronutrients
Antithrombin III

Additional relevant MeSH terms:

Anticoagulants
Coagulants
Molecular Mechanisms of Pharmacological Action
Growth Substances
Physiological Effects of Drugs
Hematologic Agents
Vascular Diseases
Fibrinolytic Agents
Cardiovascular Agents
Thrombosis
Pharmacologic Actions

Hemostatics
Enoxaparin
Embolism and Thrombosis
Fibrin Modulating Agents
Antifibrinolytic Agents
Therapeutic Uses
Vitamins
Vitamin K
Venous Thrombosis
Cardiovascular Diseases
Micronutrients

ClinicalTrials.gov processed this record on May 06, 2009