EUCTR2005-002160-28-AT进行中（未招募）不适用
Safety and efficacy of long-term treatment with atorvastatin in patients with primary biliary cirrhosis
Medical University Graz,Department of Internal Medicine, Division of Gastroenterology and Hepatology0 个研究点目标入组 80 人开始时间: 2005年8月19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
- 80
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
- All
入选标准
- •Inclusion criteria (PBC):
- •LDL-cholesterol >= 130 mg/dl
- •Primary biliary cirrhosis (AMA positive or biopsy proven)
- •Male or female gender
- •Age 18-70 years
- •Normal kidney function
- •Inclusion criteria (non-PBC):
- •LDL-cholesterol >= 130 mg/dl matched for age, gender, glucose metabolism and vascular disease manifestations
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Primary biliary cirrhosis Stage III-IV (Ludwig Score)
- •Liver cirrhosis
- •Decompensated liver disease ( > Child-Pugh class B, ascites, esophageal varices)
- •ALT or AST > 2x ULN
- •Pregnancy or breastfeeding
- •Premenopausal women without certain contraception
- •Known hypersensitivity to HMG-CoA reductase inhibitors
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