LBCTR2021034776已完成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)
ovartis Pharma Services inc.0 个研究点目标入组 3 人开始时间: 2024年5月17日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 3
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 12 至 17（—）
- 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
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 protocol-defined inclusion/exclusion criteria may apply
研究者
相似试验
已完成
3 期
Study to Evaluate Efficacy and Safety of Inclisiran in Adolescents With Homozygous Familial HypercholesterolemiaHomozygous Familial HypercholesterolemiaE78.5heterozygous familial hypercholesterolemiaLBCTR2021034779ovartis Pharma Services inc.1
进行中（未招募）
1 期
Study to evaluate efficacy and safety of inclisiran in adolescents with heterozygous familial hypercholesterolemiaMedDRA version: 20.0Level: LLTClassification code 10057079Term: Heterozygous familial hypercholesterolemiaSystem Organ Class: 100000004850Heterozygous Familial HypercholesterolemiaEUCTR2020-002757-18-DEovartis Pharma AG130
进行中（未招募）
1 期
Study to evaluate efficacy and safety of inclisiran in adolescents with heterozygous familial hypercholesterolemiaMedDRA version: 20.0Level: LLTClassification code 10057079Term: Heterozygous familial hypercholesterolemiaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersHeterozygous Familial HypercholesterolemiaEUCTR2020-002757-18-SKovartis Pharma AG130
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)elevated LDL-cholesterol1000751010057166heterozygous familial hypercholesterolemiaNL-OMON54301ovartis24
进行中（未招募）
1 期
Study to evaluate efficacy and safety of inclisiran in adolescents with heterozygous familial hypercholesterolemiaHeterozygous Familial HypercholesterolemiaEUCTR2020-002757-18-PLovartis Pharma AG130