EUCTR2009-017622-39-SI进行中（未招募）不适用
A double blind, randomized study to compare influence of niacin/laropiprant on functional and morphological characteristics of arterial wall and parameters of inflammation in subjects with CHD already treated with a statin
Clinical Center Ljubljana0 个研究点目标入组 62 人开始时间: 2010年4月9日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 62
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
- Male
入选标准
- •-age 35-55, with
- •-confirmed CHD (post MI patients, coronarography and/or cycloergometry)
- •-already treated for dyslipidemia with a statin and reaching ESC LDL target
- •-HDL-C <1.1 mmol/l, TG > 1,7 mmol/l and LDL < 2,6 mmol/L
- •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
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-3x increase of liver enzyme tests or CK
- •-severe renal insufficiency – creatinin >200 mmol/l,
- •-acute disease within 6 weeks prior to inclusion,
- •-hypersensitivity to nicotinic acid
- •-other cardiac medication stable for at least 4 weeks prior to enrollment
- •-Acute MI, CABG, PCI within past 3 months.
- •-Congestive heart failure (CHF) _ NYHA 2.
- •-Ejection fraction < 40% measured within the past 6 months.
- •-Malignancy.
- •-HIV infection or immunodeficiency state.
- •-Stable dose of statin < 6 weeks
- •-Diabetes mellitus type 1.
- •-Diabetes mellitus type 2 with HbA1C > 7%
- •-Hypo/hyper thyroidism.
- •-Alcohol or drug abuse
研究者
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