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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
613
10 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).
20 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).
30 mg bid main treatment period of 21 days followed by an extended period of trial therapy until week 12 (Day 84).
Response to treatment as determined by a Complete Compression Ultra sound (CCUS)
Time frame: 21 days
Response to treatment as determined by a Complete Compression Ultrasound (CCUS) and perfusion lung scan
Time frame: Day 21
Response to treatment and residual vein diameter as assessed by Complete Compression Ultrasound (CCUS)
Time frame: Day 84
Incidence of symptomatic and confirmed recurrence or extension of Deep Vein Thrombosis (DVT)
Time frame: 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
Time frame: 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
Time frame: Day 1-114
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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 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
Unnamed facility
Sydney, New South Wales, Australia
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Adelaide, South Australia, Australia
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Adelaide, South Australia, Australia
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Melbourne, Victoria, Australia
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Melbourne, Victoria, Australia
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Melbourne, Victoria, Australia
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Perth, Western Australia, Australia
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Graz, Styria, Austria
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Vienna, Austria
Unnamed facility
Vienna, Austria
...and 100 more locations