NCT00292435已完成3 期
A 12-week, Double-blind, Randomised, Placebo-controlled, Multicentre Trial to Evaluate Efficacy and Tolerability of Antistax Film-coated Tablets, 360 mg/Day Orally, in Male and Female Patients Suffering From Chronic Venous Insufficiency.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 20
- 主要终点
- Change from baseline in limb volume of the more affected leg on day 84 , determined by water displacement.
研究概览
简要总结
To determine efficacy and tolerability of Antistax 360 mg tablets in chronic venous insufficiency linked to edema (swelling) and subjective symptoms
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Double
入排标准
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Change from baseline in limb volume of the more affected leg on day 84 , determined by water displacement.
时间窗: 84 days
次要结局
- Change from baseline in quality of life as determined by the Tuebingen QoL Questionnaire on day 84(84 days)
- Change from baseline in calf circumference on days 21, 42, and 84(21, 42 and 84 days)
- Global assessment of efficacy by the patient on day 84(84 days)
- Global assessment of efficacy by the investigator on day 84(84 days)
- Incidence of adverse events(84 days)
- Global assessment of tolerability by the patient and by the investigator on day 84.(day 84)
- Change from baseline in limb volume on days 21 and 42 determined by water displacement.(21 and 42 days)
- Change from baseline in the subjective symptoms of CVI (tired heavy legs, sensation of tension in the legs, tingling sensations in the legs, pain in the legs) measured by visual analogue scales (VAS) on days 21, 42, and 84(21, 42 and 84 days)
- Measurement of vital signs (pulse rate, blood pressure)(84 days)
研究者
研究点 (20)
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