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临床试验/EUCTR2010-019954-42-DE
EUCTR2010-019954-42-DE进行中(未招募)不适用

Effect of Niacin/ Laropiprant on postprandial lipoprotein and glucose metabolism in patients with severe dyslipoproteinemia

Med. Klinik II, Klinikum der Universität München Grosshadern0 个研究点开始时间: 2010年7月7日最近更新:
适应症
相关药物

试验速览

阶段
不适用
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
All

入选标准

  • Men and postmenopausal women (19-70 years)
  • High risk patients (PROCAM risk > 20%) on a stable statin-therapy with simvastatin, but at least 20 mg/d
  • HDL-cholesterol < 50 mg/dl, triglycerides 150-400 mg/dl, LDL-cholesterol 70-150 mg/dl
  • Without niacin therapy for at least 6 months
  • Lipoprotein (a) < 30 mg/dl
  • Dosage of concomitant medication has been stable for at least 3 weeks
  • If female, postmenopausal for the past 12 months
  • 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
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range

排除标准

  • Subjects with additional causes for hyperlipoproteinemia
  • Diabetes mellitus or antidiabetic medication
  • History of cardiovascular ischemia in previous 3 months or acute myocardial infarction or unstable angina
  • History of alcoholism
  • History of psychiatric disorder
  • Contraindication against niacin/ laropiprant
  • Fasting triglycerides > 400 mg/dl
  • Major hepatic impariment
  • Active peptic ulcer disease
  • Renal insufficiency
  • Life threatening disease

研究者

发起方
Med. Klinik II, Klinikum der Universität München Grosshadern

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