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

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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)
Drug: Xarelto (Rivaroxaban, BAY59-7939)
Drug: Xarelto (Rivaroxaban, BAY59-7939)
Drug: Xarelto (Rivaroxaban, BAY59-7939)
Arm 2
Experimental group
Treatment:
Drug: Xarelto (Rivaroxaban, BAY59-7939)
Drug: Xarelto (Rivaroxaban, BAY59-7939)
Drug: Xarelto (Rivaroxaban, BAY59-7939)
Drug: Xarelto (Rivaroxaban, BAY59-7939)
Arm 3
Experimental group
Treatment:
Drug: Xarelto (Rivaroxaban, BAY59-7939)
Drug: Xarelto (Rivaroxaban, BAY59-7939)
Drug: Xarelto (Rivaroxaban, BAY59-7939)
Drug: Xarelto (Rivaroxaban, BAY59-7939)
Arm 4
Experimental group
Treatment:
Drug: Xarelto (Rivaroxaban, BAY59-7939)
Drug: Xarelto (Rivaroxaban, BAY59-7939)
Drug: Xarelto (Rivaroxaban, BAY59-7939)
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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Data sourced from clinicaltrials.gov

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