Placebokontrollierte Untersuchung zur Wirkung von Nikotinsäure auf die Dyslipidämie bei Metabolischem Syndrom und das Arterioskleroserisiko - Niaspan

Gesellschaft für Wissens- und Technologietransfer der TU Dresden mbH0 个研究点开始时间: 2005年11月3日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•Patients with dyslipidemia (triglycerides >= 150 mg/dl and/or decreased levels of HDL-cholesterol <40 mg/dl in men or < 50 mg/dl in women) and with further components of the metabolic syndrome:
•Hypertension: blood pressure >= 130/85 mmHg or/and
•Hyperglycemia: fasting plasma glucose >= 100 mg/dl or/and
•2 hour plasma glucose after 75g glucose load (OGTT) >= 140 mg/dl or/and
•Obesity: waist circumferences > 102 cm in men or >88 cm in women
•age between 30 and 75 years
•informed consent
•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

•-Contraindication and incompatibility of nicotine acid
•-Patients with ulcus ventriculi or ulcus duodeni
•-Intake of lipid lowering drugs < 6 weeks before randomization
•-therapy of type 2 diabetes with insulin, glitazones, acarbose or more than one antidiabetic drug (only mono-therapy with metformin or sulfonyl urea is permit)
•-no acceptable therapy of diabetes with levels of HbA1C>=8.0%
•-cardiovascular events in the last 6 months
•-chronic inflammatory diseases (lupus erythematodes, arthritis, morbus Crohn or colitis ulcerosa)
•-ALAT elevation 2.5 times more than the normal limit
•-pregnancy

发起方

Gesellschaft für Wissens- und Technologietransfer der TU Dresden mbH