Acute deep vein thrombosis MedDRA version: 7.0 Level: Code Classification code 10051055
Conditions
Interventions
Product Name: N/A
Product Code: BAY 59-7939
Pharmaceutical Form: Tablet
INN or Proposed INN: proposed INN: rivaroxaban
CAS Number: 366789-02-8
Other descriptive name: 2-Thiophenecarboxamide, 5-chloro
Sponsors
Bayer HealthCare AG
Eligibility
Sex/Gender
All
Inclusion criteria
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
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 200 mmHg, DBP > 100 mmHg). ? Impaired liver function (transaminases > 2 x ULN). ? Impaired renal function (serum creatinine > 1.5 x ULN or creatinine clearence 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objectives of this Phase II dose finding trial are to assess the efficacy and safety of BAY 59-7939 for the treatment of acute symptomatic proximal deep vein thrombosis (objectively confirmed by complete compression ultrasound - CCUS) in male and female patients aged 18 years or above. Patients with symptomatic pulmonary embolism at study entry will be excluded. Pharmacokinetic and pharmacodynamic parameters (incl, activated partial thrombin time (aPTT), prothrombin time (PT, INR) Factor Xa activity and Heptest) will also be assessed ;Secondary Objective: ;Primary end point(s): The primary efficacy endpoint will be the response to treatment as determined by CCUS after three weeks of treatment. A positive response is defined as an improvement in the CCUS score compared to baseline. However, any confirmed symptomatic recurrence of extension of DVT, any confirmed symptomatic PE or any VTE-related death up to Day 21 defines a negative response even in case of an improved CCUS at Day 21 Secondary efficacy endpoints are: ? Response to treatment at Day 21 as determined by CCUS and perfusion lung scan where a positive response is defined as an improvement in the CCUS and /or perfusion lung scan without any deterioration in either. ? Response to treatment at Day 84 as assessed by CCUS. ? Residual vein diameter as assessed by CCUS on Day 84. ? Incidence of symptomatic and confirmed recurrence or extension of DVT during the 3 months treatment period. ? Incidence of symptomatic and confirmed PE during the 3 months treatment period. ? Composite endpoint of symptomatic and confirmed recurrence and extension of DVT and symptomatic PE (nonfatal DVT and/or nonfatal PE) and deaths during the 3 months treatment period. ? Composite endpoint of symptomatic and confirmed recurrence and extension of DVT and symptomatic PE (nonfatal DVT and/or nonfatal PE) and deaths related to VTE during the 3 months treatment period. ? Incidence of symptomatic and confirmed recurren | — |
Countries
Hungary, United Kingdom
Outcome results
None listed