Comparative Efficacy Evaluation of Lipids When Treated With Niaspan & Statin or Other Lipid-Modifying Therapies-COMPELL
|Dyslipidemia Coronary Heart Disease Atherosclerosis Stroke Diabetes||Drug: Niacin Drug: Atorvastatin Drug: Simvastatin Drug: Ezetimibe Drug: Rosuvastatin||Phase 4|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Comparative Efficacy Evaluation of Lipid Levels When Treated With Niaspan and Statin or Other Lipid-Modifying Therapies|
- Mean percent change in LDL-C from Baseline to Week 12
|Study Start Date:||April 2004|
|Estimated Study Completion Date:||May 2005|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00079638
|Principal Investigator:||COMPELL TEAM||Contact COMPELL Team Member (800) 722-4567|