EUCTR2008-005612-40-IT进行中（未招募）不适用
Open-label, controlled, randomised, multicentre, parallel group clinical trial of efficacy and tolerability of heparan sulfate slow-release 120 mg tablets and defibrotide 400 mg capsules in the treatment of clinical findings of chronic venous insufficiency - ND
FARMACEUTICI DAMOR0 个研究点开始时间: 2008年12月30日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients will be enrolled at Visit 1 if they meet all the following criteria: 1. Written informed consent obtained; 2. Outpatients of either sex, aged between 18 and 75 years; 3. Patients with ultrasonography-confirmed chronic venous insufficiency (CVI); 4. Diagnosed CEAP (clinical component) class 2-5 CVI; 5. Presence of at least two subjective symptoms and of at least two signs of CVI (of at least moderate degree, i.e. score ≥ 2); 6. Patient?s co-operative attitude and able to understand and adhere to study protocol procedures and timelines.
- •Are the trial subjects under 18? no
- •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
排除标准
- •Patients will not be enrolled at Visit 1 if they meet any of the following criteria: 1. Patients being treated with anticoagulant, fibrinolytic, antiplatelet, hemorheologic agents; 2. Patients being treated with concomitant drugs potentially acting on coagulation or platelet aggregation parameters; 3. History or current evidence of cardiovascular diseases, e.g. congestive heart failure NYHA class > 1, coronary artery disease, myocardial infarction, severe hypertension, cardiac arrhythmias; 4. History or current evidence of liver (i.e. AST/ALT higher than twice the upper limit of normal range) or renal (i.e. creatinine > 2 mg/dl) insufficiency, of metabolic or endocrine diseases (e.g. uncontrolled diabetes mellitus), or of any other underlying medical condition that might interfere with the study evaluation parameters; 5. History or current evidence of DVT; 6. Evidence of venous, diabetic or ischemic leg ulcers; 7. Presence of peripheral artery obstructive disease; 8. Immunocompromised patients; 9. Malignant disease or any other disease with life expectancy less than 2 years; 10. History of alcoholism, drug abuse, psychological or other psychiatric diseases that could invalidate informed consent or limit the subject compliance with protocol requirements; 11. Patients on artificial enteral or parenteral feeding; 12. Allergy, sensitivity or intolerance to study drugs and/or any of study drug formulation ingredients; 13. Pregnant or breastfeeding females, or those females not practicing adequate contraceptive measures; 14. Patients unlikely to comply with the protocol or unable to understand the nature, scope and possible consequences of the study; 15. Patients who received any investigational drug within the last 12 weeks; 16. Patients who have been previously enrolled in this study; 17. Employees of the investigator or study centre (i.e., principal investigator, sub-investigator, study coordinators, other study staff, employees, or contractors of each), with direct involvement in the proposed study or other studies under the direction of that investigator and/or study centre, as well as family members of the employees or the investigator.
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