NCT01166633已完成4 期
A Randomized , Open Label, Dose Titration Study to Evaluate the Effect of Pitavastatin Versus Atorvastatin in Patients With Hypercholesterolemia and Mild to Moderate Hepatic Damage
JW Pharmaceutical0 个研究点目标入组 200 人开始时间: 2009年6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
- 200
- 主要终点
- Proportion of the subjects whose ALT levels were over CTCAE grade II after treatment
研究概览
简要总结
Statin is an effective drug to treat hyperlipidemia (hypercholesterolemia), and it rarely leads to hepatic damage to the patients with hepatic disorder. For these patients, intensive monitoring is required.
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
- 25 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged between 25 and 75
- •Patients who signed informed consent forms of their own volition;
- •Patients who had taken statins for 2 months and longer or whose fasting LDL-C levels, were 130mg/dL and over (Friedewald's formula);
- •Patients whose ALT levels were 1.25 to 2.5 times higher than the upper limit of normal
排除标准
- •Patients with uncompensated liver cirrhosis.
- •Patients whose total bilirubin levels were over 2 times higher than the upper limit of normal.
- •Patients who had taken antiviral drugs for viral hepatitis.
- •Patients who experienced cerebrovascular diseases or myocardial infarction within 3 months before screening visit or patients with heart failure (NYHA class IV).
- •Patients whose triglyceride(TG) levels were 400mg/dL or higher.
- •Patients with uncontrolled hypertension (DBP≧100mmHg)
- •Patients under suspicion of renal dysfunction (serum creatinine≧2.0mg/dL)
- •Patients whose CK levels were over 2.5 times higher than the upper limit of normal.
- •Patients with uncontrolled hypothyroidism although drug treatment (TSH≧ULN×1.5)
- •Female patients who were nursing or being pregnant or were planning on becoming pregnant.
- •Patients judged to be unsuitable by investigators.
研究组 & 干预措施
Pitavastatin 2 mg
Experimental
干预措施: pitavastatin (Drug)
Atorvastatin 10mg
Active Comparator
干预措施: atorvastatin (Drug)
结局指标
主要结局
Proportion of the subjects whose ALT levels were over CTCAE grade II after treatment
时间窗: 12 weeks
次要结局
- 4.Changes in fat in liver after treatment(12 weeks)
- 3.Changes in LDL-C, TC, TG and HDL-C after treatment(12 weeks)
- 1.Changes in ALT after treatment(12 weeks)
- 2.Changes in AST after treatment(12 weeks)
研究者
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