EUCTR2011-005109-56-NL进行中（未招募）1 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of SAR236553/REGN727 in Patients With Heterozygous Familial Hypercholesterolemia Not Adequately Controlled With Their Lipid-Modifying Therapy
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 486
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
- •Patients with heterozygous familial hypercholesterolemia who are not adequately controlled with their lipid-modifying therapy
- •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 682
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •Age < 18 years or legal age of adulthood, whichever is greater
- •LDL-C < 70 mg/dL (1.81 mmol/L) and with cardiovascular disease
- •LDL-C < 100 mg/dL (2.59 mmol/L) and without cardiovascular disease
- •Fasting serum triglycerides > 400 mg/dL (4.52 mmol/L)
- •Known history of homozygous familial hypercholesterolemia
研究者
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