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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: October 27, 2014
Last verified: October 2014
  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
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:


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 ]

Secondary Outcome Measures:
  • Response to treatment as determined by a Complete Compression Ultrasound (CCUS) and perfusion lung scan [ Time Frame: Day 21 ]
  • Response to treatment and residual vein diameter as assessed by Complete Compression Ultrasound (CCUS) [ Time Frame: Day 84 ]
  • Incidence of symptomatic and confirmed recurrence or extension of Deep Vein Thrombosis (DVT) [ Time Frame: Day 1-84 ]
  • 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 ]
  • 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 ]

Enrollment: 613
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   (Adult, Senior)
Sexes Eligible for Study:   All
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
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: NCT00839163

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

Additional Information:
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: October 27, 2014

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

Additional relevant MeSH terms:
Thrombosis
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Vitamins
Vitamin K
Rivaroxaban
Factor Xa Inhibitors
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antithrombins
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticoagulants
Antifibrinolytic Agents
Fibrin Modulating Agents
Hemostatics
Coagulants

ClinicalTrials.gov processed this record on February 24, 2017