NCT00529178已完成4 期
A Multicenter, Randomized, Double-blind, Placebo Controlled, Parallel Study to Determine the Efficacy and Safety of Pravastatin 80 mg Administered Once Daily to Hypercholesterolemic Subjects With Chronic, Well Compensated Liver Disease
Bristol-Myers Squibb0 个研究点目标入组 232 人开始时间: 2002年12月最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 232
- 主要终点
- ALT value
研究概览
简要总结
To determine in hypercholesterolemic subjects with chronic, well-compensated liver disease, the percent change from baseline to Week 12 in serum LDL-C of pravastatin 80 mg compared to placebo.
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
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic, well-compensated stable liver
- •Hypercholesterolemia
排除标准
- •Signs or symptoms of ascites, jaundice, or cirrhosis with a Child-Pugh Score > 5
- •History of disorders affecting serum bilirubin levels, more than 1 chronic liver disease, significant endocrine, renal, or gastrointestinal disease, or uncontrolled hypertension
- •Treatment with lipid-lowering drugs, unless they have been withdrawn within the timeframe specified in the protocol
结局指标
主要结局
ALT value
serum LDL-C
时间窗: at week 12
次要结局
- change in HDL-C, TC and TG(at week 12)
- clinical symptoms related to acute hepatic injury
研究者
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