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

Phase 2

Completed

• Conditions: Venous Thrombosis; Deep Vein Thrombosis
• Interventions: Drug: Xarelto (Rivaroxaban, BAY59-7939); Drug: Enoxaparin/Vitamin K-Antagonist

• Registration Number: NCT00839163
• Lead Sponsor: Bayer

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2004-03
• Primary Completion: 2005-10
• Study Completion: 2005-10
• Study First Submitted: 2009-02-06
• Study First Submitted QC: 2009-02-06
• Study First Posted: 2009-02-09
• Status Verified: 2014-10
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 613

Inclusion Criteria

• Patients with acute symptomatic proximal deep vein thrombosis

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm 4	Xarelto (Rivaroxaban, BAY59-7939)	-
Arm 5	Enoxaparin/Vitamin K-Antagonist	-
Arm 1	Xarelto (Rivaroxaban, BAY59-7939)	-
Arm 2	Xarelto (Rivaroxaban, BAY59-7939)	-
Arm 3	Xarelto (Rivaroxaban, BAY59-7939)	-

Primary Outcome Measures

Name	Time	Method
Response to treatment as determined by a Complete Compression Ultra sound (CCUS)	21 days

Secondary Outcome Measures

Name	Time	Method
Response to treatment as determined by a Complete Compression Ultrasound (CCUS) and perfusion lung scan	Day 21
Response to treatment and residual vein diameter as assessed by Complete Compression Ultrasound (CCUS)	Day 84
Incidence of symptomatic and confirmed recurrence or extension of Deep Vein Thrombosis (DVT)	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	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	Day 1-114