EUCTR2017-003633-28-RO进行中（未招募）1 期
Clinical non-inferiority study between Micronized purifiedflavonoid fraction 1000 mg, one chewable tablet per day andMicronized Purified Flavonoid Fraction 500 mg, 2 tabletsdaily after eight weeks of treatment in patients suffering fromsymptomatic Chronic Venous Disease (CVD).International, multicenter, double-blind, randomized, parallelgroup study - Micronized purified flavonoid fraction 1000 mg, one chewable tablet per day – CHEWY
Institut de Recherches Internationales SERVIER (I.R.I.S.)0 个研究点目标入组 611 人开始时间: 2022年5月17日最近更新:
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
- 611
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
- •- patient 20 to 75 years old inclusive,
- •- male or female,
- •- 18 kg/m² = BMI = 35 kg/m²,
- •- suffering from primary chronic venous disease, with lower limb discomfort superior or equal to
- •4 cm on eVAS,
- •- clinical class C0s to C4s on the most affected leg, according to the Clinical Etiological Anatomic
- •Pathophysiologic (CEAP) classification.
- •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 524
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 46
排除标准
- •- unlikely to co-operate in the study,
- •- unable to fill in a questionnaire or a ePRO by himself,
- •- severe locomotor disability,
- •- patient who had a total or partial leg/foot amputation,
- •- pregnancy, breastfeeding, or woman of child bearing potential without an effective contraceptive
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