EUCTR2021-002311-64-CZ进行中（未招募）1 期
Efficacy and safety of sulodexide in the treatment of chronic primary venous disease of the lower extremities: randomized double-blind placebo-controlled clinical trial - SuloPrima
ALFASIGMA CZECH s.r.o.0 个研究点目标入组 290 人开始时间: 2021年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 290
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
- •Diagnosed primary venous disease of the lower limbs in stage C2 - C6 according to the CEAP classification, clinical involvement of the venous system of the lower limbs is verified by duplex ultrasonography
- •Presence of objective and subjective symptoms of the disease (classified according to rVCSS score = 4)
- •The patient signed informed consent for inclusion in the clinical trial and consent to the processing of personal data
- •Patient over 18 years of age
- •Both male and female subjects will be enrolled. Female patients 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); OR of childbearing potential but with a negative pregnancy test result at Visit 1 AND agrees to use a highly effective method of contraception
- •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 145
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 145
排除标准
- •Use of a drug with venoactive effect in the last month
- •Regular use of mechanical devices for reduction of oedema in the last month with the exception of compression therapy
- •Patients who had used compression therapy and stopped early before enrolment (for less than one month)
- •Heart Failure as per NYHA III and IV, congestive heart failure with peripheral oedemas
- •Chronic kidney disease with GF < 30 ml/min (< 0,5 ml/s) and/or proteinuria > 0,5 g/24 hours, nephrotic syndrome, renal oedemas
- •Advanced liver disease (Child-Pugh B and C or laboratory values of ALT or AST more than 3 times upper limit of normal range)
- •Deep venous thrombosis lower limb thrombosis and / or documented residual venous obstruction or deep venous reflux due to post-thrombotic changes in the deep venous system
- •Superficial venous thrombosis of the lower limbs in the previous 6 months
- •Congenital venous / venolymphatic venous malformation
- •Neuropathy of any aetiology
- •Diabetic foot syndrome
- •Refractory (uncontrollable) arterial hypertension (inability to achieve therapeutically systolic blood pressure = 160 mmHg or diastolic blood pressure = 100 mmHg)
- •Symptomatic ischemic disease of lower limbs
- •Lymphoedema: primary, posttraumatic, postoperative, post-radiation, malignant
- •Manual/instrumental lymphatic drainage in the last 6 months
- •Invasive procedure on the lower limbs in the last 6 months
- •Trauma of the lower extremity that has not fully healed
- •Use of oral/parenteral anticoagulants, dual antiplatelet therapy, diuretics, corticosteroids
- •Chronic pain treatment = 14 days
- •Psychopharmaceuticals affecting fluid retention (antipsychotics, combined antidepressants)
- •Pathologic obesity (BMI > 40 kg/m2)
- •The patient is currently enrolled in another interventional or non-interventional study
- •Contraindications to the administration of sulodexide according to IB (haemorrhagic diathesis, hypersensitivity to the drug substance or any of the excipients, heparin, heparinoids or other glycosaminoglycans (GAGs), etc.)
- •Patients with active malignant disease or malignant disease in remission for less than 5 years
- •Pregnancy
- •Breastfeeding
研究者
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