EUCTR2020-002757-18-HU进行中（未招募）1 期
Two part (double-blind inclisiran versus placebo [Year 1] followed by open-label inclisiran [Year 2]) randomized multicenter study to evaluate safety, tolerability, and efficacy of inclisiran in adolescents (12 to less than 18 years) with heterozygous familial hypercholesterolemia and elevated LDL-cholesterol (ORION-16)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 150
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
- •Heterozygous Familial Hypercholesterolemia (HeFH) diagnosed either by genetic testing or on phenotypic criteria
- •Fasting LDL-C >130 mg/dL (3.4 mmol/L) at screening
- •Fasting triglycerides <400 mg/dL (4.5 mmol/L) at screening
- •On maximally tolerated dose of statin (investigator’s discretion) with or without other lipid-lowering therapy; stable for = 30 days before screening
- •Estimated glomerular filtration rate (eGFR) >30 mL/min/1.73 m2 at screening
- •Other inclusion criteria are listed in the clinical study protocol
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 150
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Homozygous familial hypercholesterolemia (HoFH)
- •Active liver disease
- •Secondary hypercholesterolemia, e.g. hypothyroidism or nephrotic syndrome
- •Major adverse cardiovascular events within 3 months prior to randomization
- •Previous treatment with monoclonal antibodies directed towards PCSK9 (within 90 days of screening)
- •Recent and/or planned use of other investigational medicinal products or devices
- •Other exclusion criteria are listed in the clinical study protocol
研究者
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