NL-OMON54301招募中3 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) - CKJX839C12301 ORION-16
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- ovartis
- 入组人数
- 24
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
- 12 至 17（—）
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 protocol
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
- •Other exclusion criteria are listed in the clinical study protocol
研究者
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