EUCTR2014-005473-36-DE进行中(未招募)1 期
Modeling of lipoprotein in patients with familial hypercholesterolemia compared to healthy subjects
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
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