Comparative Efficacy Evaluation of Lipids When Treated With Niaspan & Statin or Other Lipid-Modifying Therapies-COMPELL
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|ClinicalTrials.gov Identifier: NCT00079638|
Recruitment Status : Completed
First Posted : March 12, 2004
Last Update Posted : November 1, 2006
|Condition or disease||Intervention/treatment||Phase|
|Dyslipidemia Coronary Heart Disease Atherosclerosis Stroke Diabetes||Drug: Niacin Drug: Atorvastatin Drug: Simvastatin Drug: Ezetimibe Drug: Rosuvastatin||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||300 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Comparative Efficacy Evaluation of Lipid Levels When Treated With Niaspan and Statin or Other Lipid-Modifying Therapies|
|Study Start Date :||April 2004|
|Study Completion Date :||May 2005|
- Mean percent change in LDL-C from Baseline to Week 12
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00079638
|Principal Investigator:||COMPELL TEAM||Contact COMPELL Team Member (800) 722-4567|