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临床试验/EUCTR2016-003551-30-DE
EUCTR2016-003551-30-DE进行中(未招募)1 期

Modeling of the impact of a PCSK9 inhibition on lipoproteins in patients with dyslipidemia

niversitätsklinikum Freiburg0 个研究点目标入组 30 人开始时间: 2017年2月27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
30

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

入选标准

  • Age >=18
  • written consent
  • Criteria for a therapy with PSCK9 inhibitors are given
  • 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.severe Liver-disease g (Child-Pugh C)
  • 2. severe renal insufficiency
  • 3.TSH not im reference range
  • 4. uncontrolled aterial hypertension: Diastolic RR >=105 mmHg and/or systolic RR >=160 mmHg.
  • 5.alcohol abuse or other drug abuse (except smoking)
  • 6. blood donation within the last 6 weeks before the screening
  • 7. Patients with a severe acute disease
  • 8.HbA1c > 8.0%
  • 9. Other important severe internistic diseases, which may alter the lipidmetabolism
  • 10.hypersensitivity against the substance
  • 11.pregnancy oder planned pregnancy and lactation period

研究者

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