NL-OMON39059已完成3 期
A Double-blind, Randomized, Placebo-controlled, Multicenter Study to Evaluate Safety, Tolerability and Efficacy of AMG 145 on LDL-C in Subjects with Heterozygous Familial Hypercholesterolemia (study 20110117) - AMG20110117
Amgen BV0 个研究点目标入组 80 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 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
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Females (non-child-bearing potential or adequate contraception) and males 18-80 (inclusive) years of age.
- •Heterozygous familial hypercholesterolemia by having met the diagnostic criteria outlined by the Simon Broome Register Group (Scientific Steering Committee 1991), see protocol page 35-36 for details.
- •On an approved statin, with or without additional lipid-lowering treatment (see exclusion criteria as well), with stable dose(s) for at least 4 weeks before LDL-C screening.
- •Fasting LDL-C >= 2,6 mmol/L by central laboratory at screening.
- •Fasting triglycerides <= 4,5 mmol/L by central laboratory at screening.
排除标准
- •LDL or plasma apheresis within 4 months prior to randomization.
- •NYHA III or IV heart failure, or known left ventricular ejection fraction < 30%.
- •Uncontrolled cardiac arrhythmia, see protocol page 36 for details.
- •Myocardial infarction, unstable angina, PCI, CABG or stroke within 3 months prior to randomization.
- •Planned CABG or PCI.
- •Type 1 diabetes or newly diagnosed (within 3 months of randomization) type 2 diabetes, poorly controlled type 2 diabetes (HbA1c > 8.5%), newly diagnosed type 2 diabetes (within 6 months of randomization), laboratory evidence of diabetes during screening (fasting plasma glucose >= 7.0 mmol/L or HbA1c >= 6.5%) without prior diagnosis of diabetes.
- •Uncontrolled hypertension.
- •Red yeast rice, omega-3 fatty acids ([eg, DHA and EPA combined] [> 1000 mg/day]) or prescription lipid-regulating drugs (eg, fibrates and derivatives) other than statins, ezetimibe, bile-acid sequestering resin, stanols, or regulatory approved and marketed niacin.
- •CETP inhibitor in the last 12 months.
- •Active infection.
- •Pregnancy, inadequate contraception, breast feeding.
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