跳至主要内容
临床试验/EUCTR2019-001491-11-IT
EUCTR2019-001491-11-IT进行中(未招募)1 期

Phase IV study for efficacy and safety of Evolocumab added to Ezetimibe (Standard of Care) in high cardiovascular risk haemodialized statin intolerant patients with hypercholesterolemia. - EV01

IRCCS SAN RAFFAELE PISANA GESTITO DA SAN RAFFAELE ROMA SR0 个研究点目标入组 50 人开始时间: 2021年5月24日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
50

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 will be included in the study if all of the following criteria are met:
  • - Age = 18; both genders.
  • - High cardiovascular risk patients defined as: patients with established coronary heart disease (CHD), OR patients with CHD risk equivalents (ischemic stroke, peripheral artery disease, diabetes mellitus plus at least 2 additional risk factors);
  • - Statin-intolerant patients with not adequately controlled LDL-C levels (=70 mg/dL)
  • - Patients with uremia on periodic haemodialysis treatment.
  • 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 50
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 25

排除标准

  • - LDL-C <70 mg/dL
  • - Age < 18 years.

研究者

发起方
IRCCS SAN RAFFAELE PISANA GESTITO DA SAN RAFFAELE ROMA SR

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