NCT01743404Unknown2 期
Double-blinded Placebo-controlled Multicenter Study of Anti-atherosclerotic Activity of Inflaminat in Asymptomatic Participants With Subclinical Atherosclerosis
Institute for Atherosclerosis Research, Russia1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2007年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- B-mode ultrasound of carotid arteries
研究概览
简要总结
The purpose of this study is to investigate the anti-atherosclerotic effect of long-term anti-inflammatory therapy (Inflaminat) in asymptomatic participants with subclinical atherosclerosis of carotid arteries.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Men aged 40 to 70 years
- •Subclinical carotid atherosclerosis detected by B-mode ultrasound (increased intima-media thickness 1000-2000 mcm)
- •Arterial normotension or mild arterial hypertension (systolic blood pressure <160 mm Hg, diastolic blood pressure <90 mm Hg)
- •Absence of chronic diseases demanding permanent drug administration (more than 2 month per year)
排除标准
- •Personal history of stroke or transient ischemic attacks
- •Chronic diseases demanding drug administration more than during 2 month per year
- •Individual intolerance of Inflaminat or appearance of side effects
研究组 & 干预措施
Sugar pill
Placebo Comparator
Placebo 500 mg tablet by mouth three times a day
干预措施: Placebo (Drug)
Inflaminat
Active Comparator
Inflaminat 500 mg tablet by mouth three times a day
干预措施: Inflaminat (Dietary Supplement)
结局指标
主要结局
B-mode ultrasound of carotid arteries
时间窗: up to 2 years
Variation of intima-media thickness of common carotid arteries
次要结局
- Measure of serum atherogenicity(up to 2 years)
研究者
研究点 (1)
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