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临床试验/EUCTR2016-003253-15-NL
EUCTR2016-003253-15-NL进行中(未招募)1 期

MODULATION OF POSTPRANDIAL LIPEMIA, INFLAMMATION, AND VASCULAR FUNCTION BY PCSK9 INHIBITION IN DIABETES. - PLEIADES-pcsk9

Franciscus Gasthui0 个研究点开始时间: 2017年1月3日最近更新:
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试验速览

阶段
1 期
状态
进行中(未招募)
发起方

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

  • - Age of 18 years or older
  • - Fasting triglycerides levels between 1.8 mmol/L and 7.0 mmol/L
  • - Diabetes mellitus type 2 on intensive insulin treatment (three times short acting and one daily long acting) (unchanges for >10 weeks prior to consent)
  • - Stable glucose regulation last 6 months (HbA1c >6.5% - < <9.0%)
  • - Stable lipid lowering therapy last 2 months (no changes in regiments or dose)
  • 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 20
  • F.1.3 Elderly (>=65 years) no
  • F.1.3.1 Number of subjects for this age range

排除标准

  • - Current smoking
  • - Impaired renalfunction (MDRD <60 ml/min/1.73 m2)
  • - Recent cardiovascular event (<6 months) (myocardial infarction, coronary artery bypass grafting, stroke)
  • - Severe hyperglycemic events in the past 6 months (hyperglycemia >20 mmol/L requiring hospital admittance)
  • - Recent or current use of pcsk9 antibodies

研究者

发起方
Franciscus Gasthui

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