Multicentre, multinational, randomised, double blind, placebo-controlled study on Sulodexide for the management of leg symptoms in patients with chronic venous diseaseVEINS (VEnous INvestigation with Sulodexide) - VEINS (VEnous INvestigation with Sulodexide)

ALFASIGMA S.P.A.0 个研究点目标入组 624 人开始时间: 2021年5月20日最近更新: 2021年8月30日

试验速览

暂无简介。

•1. Male and female patients of age greater than or equal to 18 years;
•2. Able and willing to issue a signed informed consent after appropriate information and to provide a written authorization for disclosure of protected health information;
•3. With chronic venous disease;
•4. Classified by the attending physician in CEAP clinical classes 2 to 4;
•5. With symptomatic disease (where symptomatic disease in this study means: at least 2 symptoms among those composing the primary outcome measure and for a total of at least 6 score points);
•6. Female participants must be:
•- of non-childbearing potential, i.e.: post-menopausal (at least 2 years without spontaneous menses) or surgically sterile (bilateral tubal occlusion or hysterectomy) or ablation of both ovaries;
•- of childbearing potential with a negative pregnancy test result at Visit 1 AND agreeing to use a highly effective method of contraception (i.e. with failure rate of less than 1% per year).
•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 374
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 250

•1. Patients considered, by the attending physician, unable to comply with the study procedures;
•2. Women who are pregnant or during puerperium (first 6 weeks after birth) or breastfeeding at the time of examination for inclusion in the study;
•3. Sexually active women, unless willing to apply an effective method of contraception during the study;
•4. Patients with a BMI greater than or equal to 35 at screening;
•5. Patients with active cancer or cancer in remission from less than 5 years;
•6. Patients with lymphoedema;
•7. Patients with chronic heart failure with swelling requiring diuretic treatment;
•8. Patients under any type of anticoagulant treatment;
•9. Patients receiving double anti-platelet therapy;
•10. Patients under treatment with drugs that may produce oedema (e.g., calcium antagonists);
•11. Patients under treatment with systemic and/or topical phlebotropic/vasotonic drugs or substances in the last 30 days prior to randomisation;
•12. Patients using compression stockings or bandages;
•13. Patients having had invasive treatment of the superficial or deep venous compartment of the lower legs (e.g., surgery, sclerotherapy, minimal invasive treatment for varicose veins);
•14. Patients participating in other clinical trials during the last 30 days prior to screening;
•15. Patients with known hypersensitivity or intolerance to study medications or their formulation excipients.

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