CompletedPhase 2ACTRN12605000597695

Once-daily oral direct factor Xa inhibitor BAY 59-7939 in patients with acute symptomatic deep-vein thrombosis. The Einstein-DVT dose-finding study.

Once-daily oral direct factor Xa inhibitor BAY 59-7939 in patients with acute symptomatic deep-vein thrombosis to assess the dose-effect relationship and determine the optimum dose.

Sponsor

Bayer Australia Ltd

Enrollment

520 participants

Start Date

Dec 24, 2004

Study Type

Interventional

Conditions

Acute symptomatic deep-vein thrombosis

Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study tests a new oral blood-thinning medication (a factor Xa inhibitor) for treating blood clots such as deep vein thrombosis. It is open to adults aged 18 and older who have been diagnosed with blood clots. Participants would take the study drug and attend regular visits to monitor their condition.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

To assess the dose-effect relationship of once-daily BAY 59-7939 in the treatment of patients with acute symptomatic deep-vein thrombosis (DVT) using the combination of (LMW) heparin and vitamin K antagonist (VKA) as comparator. To determine the optimum once daily dose of BAY 59-7939 for use in phase III studies. Patients will receive either BAY 59-7939 (20, 30 or 40 mg, once-daily) or the combination of (LMW) heparin/VKA (INR 2.0-3.0). The study duration is 12 weeks followed by an additional observational period of 30 days.

Locations(1)

Australia

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ACTRN12605000597695