Hypercholesterolemia
Conditions
Keywords
Dyslipidemia, High Blood Cholesterol, Coronary Heart Disease, Hypertension, National Cholesterol Education Program, Adult Treatment Panel III, Niacin, Simvastatin, Diabetes, Peripheral Vascular Disease, Cerebrovascular disease, Stroke, High-Density Lipoprotein Cholesterol, Hydroxymethyl Glutaryl Coenzyme A, High-Sensitivity C-Reactive Protein, Low-Density Lipoprotein Cholesterol, Lipoprotein (a), Lipoprotein A-I, Total Cholesterol, Triglycerides
Brief summary
The purpose of this study is to compare the effectiveness and safety of different doses of Niacin ER/Simvastatin (NS), in subjects with elevated fat levels in their blood (dyslipidemia).
Detailed description
The purpose of this study is to compare the efficacy and safety of different doses of Niacin ER/Simvastatin (NS), in subjects with elevated fat levels in their blood (dyslipidemia).
Interventions
DRUGNiacin extended release and simvastatin tablets
Sponsors
Kos Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient has primary Type II hyperlipidemia or mixed dyslipidemia * If the patient is currently taking anti-dyslipidemic medications other than Zocor, he/she is willing to withdraw from these medications * Reasonable compliance with a standard cholesterol-lowering diet for a minimum of 4 weeks prior to screening and for the duration of the study. * LDL-C levels and/or Non HDL-C levels above normal for patients This study will be conducted both in the USA and internationally.
Exclusion criteria
* Patient has an allergy, hypersensitivity, or intolerance to niacin, statins, or their derivatives * HbA1c ≥ 9% in diabetic patients
Outcome results
None listed