NCT01595828已完成1 期
An Open Label Study of the Chronic and Acute Effects of Pitavastatin on Monocyte Phenotype, Endothelial Dysfunction and HDL Atheroprotective Function in Subjects With Metabolic Syndrome (CAPITAIN)
Kowa Research Europe1 个研究点 分布在 1 个国家目标入组 14 人开始时间: 2010年10月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Change from baseline to Day 180 in plasma biomarkers of inflammation and atherosclerosis, including monocytes, lymphocytes, endothelial adhesion proteins, atherogenic lipoproteins and cardioprotective HDL
研究概览
简要总结
The purpose of this study is to examine in detail the acute and chronic effects of pitavastatin on plasma lipid transport and atheroma biomarkers in patients at elevated risk for the premature development of atherosclerosis (CAPITAIN).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with metabolic syndrome
- •Patients with LDL-C > 130mg/dL
- •Eligible, able to participate and have given informed consent
排除标准
- •Body Mass Index >35 kg/m2
- •LDL-C > 190mg/dL
- •Fasting triglycerides > 400 mg/dL
- •Diabetes mellitus (fasting glucose >7 mmol/L) or taking diabetic therapy
- •Uncontrolled hypertension (Systolic Blood Pressure >= 140 mmHg or Diastolic Blood Pressure >= 90mmHg)
- •Any conditions that cause secondary dyslipidaemia or increase the risk of statin therapy
- •ALAT and ASAT >3 x ULRR
- •Impaired renal function (Serum Creatinine >1.5 x ULRR or eGFR <60 mL/min)
- •History of any muscle disease or unexplained elevation (>3 x ULRR) of serum creatine kinase
- •Evidence of symptomatic heart failure (NYHA class III or IV)
- •Current or recent user of supplements or medications known to alter lipid metabolism
研究组 & 干预措施
Pitavastatin 4mg daily
Experimental
4 mg tablets of pitavastatin by oral route for a period of 6 months
干预措施: Pitavastatin (Drug)
结局指标
主要结局
Change from baseline to Day 180 in plasma biomarkers of inflammation and atherosclerosis, including monocytes, lymphocytes, endothelial adhesion proteins, atherogenic lipoproteins and cardioprotective HDL
时间窗: 180 days
次要结局
未报告次要终点
研究者
研究点 (1)
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