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

Bayer

Status and phase

Completed

Phase 2

Conditions

Deep Vein Thrombosis

Venous Thrombosis

Treatments

Drug: Enoxaparin/Vitamin K-Antagonist

Drug: Xarelto (Rivaroxaban, BAY59-7939)

Study type

Interventional

Funder types

Industry

Identifiers

NCT00839163

2004-001083-43 (EudraCT Number)

11223 (Registry Identifier)

ODIXa-DVT (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

613 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

613 participants in 5 patient groups

Arm 1

Experimental group

Treatment:

Drug: Xarelto (Rivaroxaban, BAY59-7939)

Arm 2

Experimental group

Treatment:

Drug: Xarelto (Rivaroxaban, BAY59-7939)

Arm 3

Experimental group

Treatment:

Drug: Xarelto (Rivaroxaban, BAY59-7939)

Arm 4

Experimental group

Treatment:

Drug: Xarelto (Rivaroxaban, BAY59-7939)

Arm 5

Active Comparator group

Treatment:

Drug: Enoxaparin/Vitamin K-Antagonist

Trial contacts and locations

110

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