Dyslipidemia (Hypertriglyzeridemia and/or low HDL-cholersterol) with metabolic syndrome
Conditions
Interventions
Trade Name: Niaspan Retardtabletten
500 mg
Product Name: Niaspan
Product Code: Niaspan
Pharmaceutical Form: Tablet
INN or Proposed INN: Niaspan
Other descriptive name: Nicotine acid
Concentration uni
Sponsors
Gesellschaft für Wissens- und Technologietransfer der TU Dresden mbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Patients with dyslipidemia (triglycerides >= 150 mg/dl and/or decreased levels of HDL-cholesterol = 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
Exclusion criteria
Exclusion criteria: - Contraindication and incompatibility of nicotine acid - Patients with ulcus ventriculi or ulcus duodeni - Intake of lipid lowering drugs =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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Placebo controlled evaluation of effectiveness of niaspan in treatment of postprandial dyslipidemia in patients with metabolic syndrome;Secondary Objective: Influence of: - markers of subclinical inflammation - changes of levels of plasma glucose and free fatty acids before and after a standard meal - albuminuria - parameters of atherosclerotic risk factors ;Primary end point(s): no defined | — |
Countries
Germany
Outcome results
None listed