跳至主要内容
临床试验/EUCTR2011-005109-56-GB
EUCTR2011-005109-56-GB进行中(未招募)不适用

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

sanofi-aventis Recherche & Développement0 个研究点目标入组 802 人开始时间: 2012年7月5日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
802

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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