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
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