Oral Direct Factor Xa Inhibitor BAY 59-7939 in Patients with acute symptomatic Deep Vein ThrombosisODIXa-DVTA prospective, randomized, multinational, multicenter, partially blinded, parallel-group, open-label active comparator controlled phase II Dose Finding and Proof of Principle Trial. - ODIXa-DVT

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 0

Inclusion Criteria

? Male and female patients aged 18 years or above (For women with childbearing potential pregnancy has to be excluded prior randomization. Females with childbearing potential must use adequate contraception method during the study).
? Patients with acute symptomatic proximal deep vein thrombosis (objectively confirmed by complete compression ultrasound).
? Patients must have signed an informed consent form for participation prior to study entry (after receiving detailed written and oral previous information to any study specific procedures)

Are the trial subjects under 18?
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Related to medical history
? TIA 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 (eg severe inflammatory bowel disease, short gut syndrome).
Related to current symptoms or findings
? Female with childbearing potential using no adequate contraception method.
(NOTE: As adequate method of birth control oral contraception is recommended. If oral contraception is not feasible or not recommended according to local guidelines both partners should use adequate barrier birth control).
? 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 (INR / aPTT not within normal limits) including patients with acquired or congenital thrombopathy.
? Thrombocytopenia (platelets < 100.000/?l).
? Macroscopic hematuria.
? Uncontrolled severe hypertension (SBP > 200 mmHg, DBP > 100 mmHg).
? Impaired liver function (transaminases > 2 x ULN).
? Impaired renal function (serum creatinine > 1.5 x ULN or creatinine clearence
< 30 ml/min).
(NOTE: If a patient meet the exclusion criteria regarding renal impairment during the study (serum creatinine > 1.5 x ULN or creatinine clearance < 30 ml/min) and this is confirmed by two consecutive measurements within 24 hours the patient should stop intake of study medication).
? 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 acetylicsalicylic acid or other platelet aggregation inhibitors (eg clopidogrel, dipyridamole and ticlopidine) must be stopped prior to randomization. Patients where continued treatment with acetylicsalicylic acid or other platelet aggregation inhibitors is clinically indicated will be excluded.
? 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 (eg ketoconazol, fluconazol, itraconazol) and other strong CYP3A4 inhibitors (eg HIV protease inhibitors). Azole compounds and other strong CYP3A4 inhibitors are not allowed within 4 days prior to randomization and during the study.

Miscellaneous
? Concomitant participation in another trial or study.
? Therapy with another investigational product within 30 days prior start of study.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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