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

ODIXa-DVTA Prospective, Randomized, Multinational, Multicenter, Partially Blinded, Parallel-group, Open-label Active Comparator Controlled Phase II Dose Finding and Proof of Principle Trial.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00839163

Enrollment

613

Registered

2009-02-09

Start date

2004-03-31

Completion date

2005-10-31

Last updated

2023-09-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Deep Vein Thrombosis, Venous Thrombosis

Keywords

Embolism and Thrombosis, Pulmonary embolism, Embolism, Thrombosis

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.

Interventions

DRUGXarelto (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).

DRUGEnoxaparin/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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
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

Countries

Australia, Austria, Belgium, Brazil, Canada, Colombia, Czechia, Germany, Hungary, Israel, Italy, Netherlands, New Zealand, Peru, Poland, South Africa, Spain, Sweden, Switzerland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026