Dyslipoproteinemia MedDRA version: 12.1 Level: LLT Classification code 10063903 Term: Dyslipoproteinemia MedDRA version: 12.1 Level: LLT Classification code 10052066 Term: Metabolic syndrome
Conditions
Interventions
Trade Name: Tredaptive 1000 mg/ 20 mg
Product Name: Tredaptive 1000 mg/ 20 mg Tabletten
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: NICOTINIC ACID
CAS Number: 59-67-6
Concentrat
Sponsors
Med. Klinik II, Klinikum der Universität München Grosshadern
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective of the trial is to evaluate the postprandial lipoprotein metabolism particularly the change of the incremental area under the plasma triglyceride curve after a standardized fat tolerance test.;Secondary Objective: Secondary objectives of the trial are to evaluate fasting lipids, postprandial postprandial glucose metabolism, monocyte function and biomarkers of endothelial dysfunction and inflammation.;Primary end point(s): Incremental area under the plasma triglyceride curve following a standardized oral fat tolerance test. | — |
Countries
Germany
Outcome results
None listed