The purpose of this study is to evaluate the effectiveness of first-line treatment using Niaspan (an extended release version of niacin) and statins versus other drugs that lower lipid levels, in subjects with elevated fat levels in their blood (dyslipidemia). Statins are a class of medication that is often prescribed to patients who need to lower their cholesterol levels.
Name of Drugs: Niaspan (niacin extended-release tablets), Lipitor® (atorvastatin), Zocor® (simvastatin), Zetia™ (ezetimibe), and Crestor® (rosuvastatin)
Study Treatment: Four open-label parallel treatment groups for 12 weeks of observation
- Niaspan and atorvastatin combination treatment titrated to 2000 mg and 40 mg, respectively;
- combination treatment of simvastatin titrated to 40 mg and ezetimibe maintained at 10 mg;
- rosuvastatin monotherapy treatment titrated to 40 mg; and
- Niaspan and rosuvastatin combination treatment titrated to 1000 mg and 20 mg, respectively.
Objective: To evaluate the relative efficacy of first-line therapy using the combination of Niaspan and atorvastatin versus the combination of simvastatin and ezetimibe versus rosuvastatin monotherapy versus the combination of Niaspan and rosuvastatin in patients with dyslipidemia.
- Male or female patients 21 years of age or older
- Patients who are eligible for treatment based upon National Cholesterol Education Program Adult Treatment Panel III (NCEP-ATP III) recommendations at the end of the Qualification period;
- All patients must have mean triglycerides (TG) ≤ 300 mg/dL.
Design: A Phase IV, 12-week, randomized, multi-center, open-label, four-arm, parallel-group study evaluating the efficacy of Niaspan and statin therapy versus other lipid-modifying therapies preceded by a four-week washout of any previous lipid-lowering therapy.
- Atorvastatin (Lipitor®)Drug
Other Names: Lipitor
- Simvastatin Drug
- Rosuvastatin (Crestor)Drug
- Niacin Drug
- Ezetimibe (Zetia)Drug
- Allocation: Randomized
- Masking: Open Label
- Purpose: Treatment
- Endpoint: Safety/Efficacy Study
- Intervention: Parallel Assignment
|Type||Measure||Time Frame||Safety Issue|
|Primary||Mean percent change in LDL-C from Baseline to Week 12|
- Kos Pharmaceuticals Lead