NCT01768481已完成3 期
Intervention précoce Sur Les Indices d'athérogénèse Des Adolescents à Risque
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- carotid intima media thickness
研究概览
简要总结
Randomized controlled trial of statin intervention in dyslipidemic obese teenagers. Primary outcome is intima media thickness before and after intervention.
详细描述
Obese teenagers with abnormal lipid profiles were randomized to either low dose statin or placebo and had their carotid intima media thickness compared before and after intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 14 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Abnormal Triglyceride levels (>1.7mmol/L).
- •Abnormal HDL-C levels (1.0mmol/L)
排除标准
- •Abnormal thyroid unfction (not treated)
研究组 & 干预措施
Statin
Experimental
Atorvastatin 10 mg every day for one year
干预措施: Atorvastatin (Drug)
Sugar pill
Placebo Comparator
Same size, taste and size placebo tablet (manufactured by sponsor) given every day for one year.
干预措施: sugar pill (Drug)
结局指标
主要结局
carotid intima media thickness
时间窗: 12 months
Carotid Intima media thickness measured at baseline and after 12 months in 2 arms (placebo and statin)
次要结局
- weight(12 months)
研究者
Laurent Legault
associate professor
Université de Montréal
研究点 (1)
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