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临床试验/EUCTR2014-005473-36-DE
EUCTR2014-005473-36-DE进行中(未招募)1 期

Modeling of lipoprotein in patients with familial hypercholesterolemia compared to healthy subjects

niversitätsklinikum Freiburg0 个研究点目标入组 12 人开始时间: 2015年1月26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)
入组人数
12

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
Male

入选标准

  • inclusion criteria for FH:
  • Age 18-75 years
  • written consent
  • positive Simon Broome criteria (possible and definitely)
  • no lipid-lowering therapy in the 6 weeks before inclusion
  • inclusion criteria control subjects:
  • Age 18-75 years
  • written consent
  • Patients without disorder of LDL metabolism, proven by< 200 mg/dl cholesteryl, < 150 mg/dl triglycerides
  • and <160 mg/dl LDL-cholesteryl in fasting plasma
  • no relevant internistic deseases and no lipidlowering therapy in the 6 weeks before inclusion
  • no lipid-lowering medication 6 weeks before the first study-associated blood withdrawl and until the second visit.
  • 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 30
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 30

排除标准

  • 1. Active Liver-disease or impairment of liver function with GOT and/or GPT > 2 x value of the Upper Limit
  • of Normal= (ULN)
  • 2. mid-level or severe renal insufficiency
  • 3. TSH not im reference range
  • 4. uncontrolled aterial hypertension: Diastolic RR 105 mmHg and/or systolic RR 160 mmHg
  • 5. lipid-lowering therapy within the last 6 weeks before the screening
  • 6. alcohol abuse, smoking or other drug abuse
  • 7. blood donation within the last 6 weeks before the screening
  • 8. Patients with a adverse acute disease
  • 9. HbA1c > 6.5%
  • 10. Other important striking internistic diseases, which may alter the lipidmetabolism

研究者

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