NCT00151788终止2 期
A Randomized, Double-blind, Stratified, Placebo-controlled, Parallel-group Study of the Efficacy and Safety of the ACAT Inhibitor CS-505 for Reducing the Progression of Atherosclerosis in Subjects With Heterozygous Familial Hypercholesterolemia and Carotid Atherosclerosis Using Carotid Ultrasound (CUS)
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 796
- 试验地点
- 37
- 主要终点
- To demonstrate the effect of pactimibe versus placebo, when added to usual medical care, on the intima-media thickness (IMT) of the carotid arteries in subjects with heterozygous familial hypercholesterolemia (HeFH) and carotid atherosclerosis.
研究概览
简要总结
The effects of pactimibe versus placebo on the progression of atherosclerosis in the carotid arteries will be assessed using standard ultrasound techniques.
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
- Double
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed diagnosis of heterozygous familial hypercholesterolemia
- •Ambulatory male (40 to 75 years, inclusive) or female (45 to 75 years, inclusive) subjects
- •Calculated LDL-C level greater than or equal to 100 mg/dL (or 2.5 mmol/L) and triglycerides less than 500 mg/dL (5.65 mmol/L) while on usual and stable lipid-lowering therapy
排除标准
- •Breast feeding or lactating women
- •Previous organ transplantation
- •High-grade stenosis (>75%) or the occlusion of any segment of either carotid artery
- •History of carotid endarterectomy, or insertion of carotid artery stent or are scheduled to have either of these procedures
结局指标
主要结局
To demonstrate the effect of pactimibe versus placebo, when added to usual medical care, on the intima-media thickness (IMT) of the carotid arteries in subjects with heterozygous familial hypercholesterolemia (HeFH) and carotid atherosclerosis.
次要结局
- To assess the effects of pactimibe versus placebo, when added to usual medical care:
- - on the incidence and the time to first occurrence of
- cardiovascular events,
- - on inflammatory and oxidative markers, such as serum
- high-sensitivity C-reactive protein (hsCRP), plasma
- interleukin 6 (IL-6), plasma myeloperoxidase (MPO) and
- serum nitrotyrosine.
- To compare the safety of pactimibe versus placebo, when added to usual medical care, particularly with respect to the incidence of clincal and laboratory adverse events.
研究者
研究点 (37)
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