None listed
Conditions
Interventions
The purpose of this study is to compare the safety and efficacy of BAY 59-7939 with the saftey and efficacy of enoxaparin and vitamin K-antagonist and to find the optimal dose of BAY 59-7939.
Patients with acute symptomatic proximal deep vein thrombosis objectively confirmed by ultrasound examination will be randomized into the study. Patients with symptomatic pulmonary embolism at study entry will be excluded.
The patients will be randomized centrally into one of the following five treatment a
The purpose of this study is to compare the safety and efficacy of BAY 59-7939 with the saftey and efficacy of enoxaparin and vitamin K-antagonist and to find the optimal dose of BAY 59-7939. Patients with acute symptomatic proximal deep vein thrombosis objectively confirmed by ultrasound examination will be randomized into the study. Patients with symptomatic pulmonary embolism at study entry will be excluded. The patients will be randomized centrally into one of the following five treatment arms: I: 10 mg bid BAY 59 7939 tablets. II: 20 mg bid BAY 59 7939 tablets. III: 30 mg bid BAY 59 7939 tablets. IV: 40 mg od BAY 59 7939 tablets. V: Enoxaparin sodium injections/vitamin K-antagonist tablets (warfarin, phenprocoumon or acenocoumarol). The dose arms of BAY 59 7939 will be blinded. The active comparator enoxaparin/vitamin K-antagonist will be open labelled. The main treatment period of 21 days is followed by an extended period of trial therapy until week 12 (Day 84). Patients should continue with the extended trial therapy to Day 84 (week 12) after the primary outcome assessment at Day 21 if the locally reported assessment of CCUS and/or perfusion lung scanning indicates no deterioration of either. If there is a locally reported but asymptomatic deterioration of either result, then investigators will apply their clinical judgment to decide if such patients should proceed with the extended period of trial therapy to Day 84 (week 12). A follow-up visit is required 30 days after the last intake of study medication.
Sponsors
Bayer Australia Ltd
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with acute symptomatic proximal deep vein thrombosis (objectively confirmed by complete compression ultrasound).
Exclusion criteria
Related to medical historyTIA or ischemic stroke within the last 6 months prior to study entry.History of heparin-induced thrombocytopenia, allergy to heparins.Intracerebral or intraocular bleeding within the last 6 months prior to study entry.History of gastrointestinal bleeding within the last 6 months prior to the study.History or presence of gastrointestinal disease which could result in an impaired absorption of the study drug.Related to current symptoms or findingsFemale with childbearing potential using no adequate contraception method.Pregnant and breastfeeding women.Symptomatic pulmonary embolism.Surgery either major or minor within the last 10 days.Neurosurgery within the last 4 weeks.Heart insufficiency NYHA III-IV.Bacterial endocarditis.Known congenital or acquired hemorrhagic diathesis including patients with acquired or congenital thrombopathy.Thrombocytopenia.Macroscopic hematuria.Uncontrolled severe hypertension.Impaired liver function (transaminases > 2 x ULN).Impaired renal function.Patients with known brain metastases.Patients receiving cytotoxic chemotherapy.Life-expectancy < 6 months.Presence of active peptic ulcer or gastrointestinal disease with increased risk of gastrointestinal bleeding or any other increased risk for bleeding (eg diabetic retinopathy).Body weight < 45 kg.Drug-or alcohol abuse.Related to current treatment Therapy with oral anticoagulants, heparins or factor Xa inhibitors other than study medication are not allowed.Therapy with platelet aggregation inhibitors must be stopped prior to randomization. Patients where continued treatment with platelet aggregation inhibitors is clinically indicated will be excluded. The therapy with acetylicsalicylic acid at daily doses up to 500 mg/d is allowed during the study and prior to randomization. Any treatment prior to randomization with heparins (exception: unfractionated heparin treatment within 36 hours, 2 therapeutic doses of a LMWH 24 hours apart or 3 therapeutic doses of a LMWH 12 hours apart. Prophylactic doses of UFH or LMWH are allowed).Fibrinolytic agents are not allowed during the study.All other drugs influencing coagulation (exception: NSAIDs with half-life < 17 hours) are not allowed during the study.Systemic and local topical treatment with azole compounds and other strong CYP3A4 inhibitors are not allowed within 4 days prior to randomization and during the study.
Outcome results
None listed