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

Deep Vein Thrombosis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00839163
• Other study ID #: 11223
• Secondary ID: 2004-001083-43OD
• Status: Completed
• Phase: Phase 2
• Start date: March 2004
• Est. completion date: October 2005

Study information

• Verified date: October 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 613
• Est. completion date: October 2005
• Est. primary completion date: October 2005
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deep Vein Thrombosis
• Thrombosis
• Venous Thrombosis

Intervention

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).
• 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).
• 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).
• 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).
• 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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to treatment as determined by a Complete Compression Ultra sound (CCUS)		21 days
Secondary	Response to treatment as determined by a Complete Compression Ultrasound (CCUS) and perfusion lung scan		Day 21
Secondary	Response to treatment and residual vein diameter as assessed by Complete Compression Ultrasound (CCUS)		Day 84
Secondary	Incidence of symptomatic and confirmed recurrence or extension of Deep Vein Thrombosis (DVT)		Day 1-84
Secondary	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
Secondary	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

External Links

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