NCT00640276已完成4 期
A Prospective Comparative Clinical Study to Identify Efficacy and Safety of Pitavastatin in Patients With a Metabolic Syndrome
JW Pharmaceutical2 个研究点 分布在 1 个国家目标入组 187 人开始时间: 2008年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 187
- 试验地点
- 2
- 主要终点
- A change of metabolic syndrome risk component
研究概览
简要总结
We will identify the influence of long-term treatment of Pitavastatin compared to non-treatment control group on the metabolic syndrome by evaluation of a change of metabolic syndrome component score. And we will additionally observe the changes of CVD risk factors like lipid profile, abdominal fat, insulin resistance and so on.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 18 and 75
- •Patients with LDL ≥ 100mg/dL
- •Patients with metabolic syndrome
- •IFG: Fasting glucose ≥ 100mg/dL
- •Abdominal Obesity: Waist circumference: men≥90cm,women≥85cm
- •1 or more of the following
- •Triglyceride ≥ 150mg/dL
- •HDL-C: men < 40mg/dL, women < 50mg/dL
- •Blood pressure: SBP ≥ 130mmHg or DBP ≥ 85mmHg or subject receiving anti-hypertensive treatment
排除标准
- •uncontrolled hypertension (DBP ≥ 95mmHg)
- •taking diabetic drugs or with HbA1c > 8%
- •LDL ≥ 190mg/dL or Triglyceride ≥ 400mg/dL
- •coronary heart disease or other diseases caused by artherosclerosis
- •malignancy within 6 months
- •Serum creatinine ≥ 2.0mg/dL
- •ALT or AST ≥ ULN*2.5
- •CPK ≥ ULN*2
- •hypothyroidism
研究组 & 干预措施
T
Active Comparator
Lifestyle modification + active drug(Pitavastatin)
干预措施: pitavastatin (Drug)
C
Other
Lifestyle Modification
干预措施: Lifestyle Modification (Behavioral)
结局指标
主要结局
A change of metabolic syndrome risk component
时间窗: 48week
次要结局
- Changes of insulin resistance : OGTT(75g), HOMA(48week)
- Changes of abdominal visceral fat(48week)
- Changes of cardiometabolic profiles : lipid profiles, hs-CRP, adiponectin, HMW adiponectin(48week)
研究者
研究点 (2)
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