Hypercholesterolemia
Conditions
Keywords
Niacin, Statin, Zocor, Simvastatin, Coronary Heart Disease, Dyslipidemia, Atherosclerosis, Hypercholesterolemia, Stroke, High-Density Lipoprotein Cholesterol, Low-Density Lipoprotein Cholesterol, Lipoprotein, Lipid, Niacin ER/simvastatin, Total Cholesterol, Triglycerides
Brief summary
The purpose of this 24 week 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). At least 600 subjects with a similar medical condition will take part in this study.
Detailed description
Objectives: To evaluate the safety and efficacy of the combination product niacin ER and simvastatin (NS) in patients with primary type II dyslipidemia and to descriptively compare flushing rates between two Titration Schedules for NS.
Interventions
DRUGNiacin Extended-Release and simvastatin Tablets
Sponsors
Kos Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
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 a lipid modifying medication other than Zocor & he/she is willing to discontinue this medication * LDL-C levels and/or non HDL-C levels above normal. * Reasonable compliance with a standard cholesterol-lowering diet for a minimum of 4 weeks prior to screening and for the duration of the study.
Exclusion criteria
* Patient has an allergy, hypersensitivity, or intolerance to niacin, statins, or their derivatives. * HbA1c ≥ 9% in diabetic patients
Outcome results
None listed