To Evaluate Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) in Patients With Type IIa or Type IIb Hyperlipidemia (0653A-091)(COMPLETED)

Study Overview
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Brief Summary
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To evaluate the efficacy and safety of ezetimibe/simvastatin and niacin in patients with high cholesterol.

Official Title
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Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin and Niacin (Extended Release Tablet) Co-Administered in Patients With Type IIa or Type IIb Hyperlipidemia

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Drug: Comparator: ezetimibe/simvastatin + niacin (ER)
* Drug: Comparator: Placebo to ezetimibe/simvastatin
* Drug: Comparator: niacin (ER) tablet
* Drug: Comparator: ezetimibe (+) simvastatin
* Drug: Comparator: Placebo to Niacin (ER)
* Drug: Comparator: ezetimibe/simvastatin and niacin (ER)
* Drug: Comparator: ezetimibe and simvastatin
* Drug: Comparator: Placebo to niacin (ER)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient with LDL-C of 130 through 190 mg/dL and Triglycerides less than or equal to 500 mg/dL Patient willing to be on a low-cholesterol diet Exclusion Criteria: Pregnant or lactating women or intending to become pregnant Patient with sensitivity or intolerance to ezetimibe, simvastatin, or ezetimibe/simvastatin combination tablet Patient with sensitivity or intolerance ro niacin, any component or niacin extended release or aspirin Patient for whom discontinuation of existing lipid-lowering therapy treatment poses an unacceptable risk

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 79 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Part 1 - Arm 1<br>ezetimibe/simvastatin combination tablet + niacin (ER) | Drug: Comparator: ezetimibe/simvastatin + niacin (ER)<br>* ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be  24 weeks<br>|
| Active Comparator: Part 1 -Arm 2<br>ezetimibe/simvastatin | Drug: Comparator: ezetimibe (+) simvastatin<br>* ezetimibe/simvastatin 10/20mg tablet. Treatment time will be  24 weeks.<br>Drug: Comparator: Placebo to Niacin (ER)<br>* Niacin (ER) (Pbo) tablet. Treatment time will be  24 weeks.<br>|
| Active Comparator: Part 1 - Arm 3<br>Niacin (ER) | Drug: Comparator: Placebo to ezetimibe/simvastatin<br>* ezetimibe/simvastatin (Pbo) tablet. Treatment time will be  24 weeks.<br>Drug: Comparator: niacin (ER) tablet<br>* niacin (ER) tablet, titrating to 2g, po qd. Treatment time will be  24 weeks<br>|
| Active Comparator: Part 2 - Arm 1<br>ezetimibe/simvastatin combination tablet + niacin (ER) | Drug: Comparator: ezetimibe/simvastatin and niacin (ER)<br>* ezetimibe/simvastatin 10/20mg tablet + niacin (ER) tablet 2g, po qd. Treatment time will be  40 additional weeks for a total of 64 weeks<br>|
| Placebo Comparator: Part 2 - Arm 2<br>ezetimibe/simvastatin combination tablet + niacin (Pbo) | Drug: Comparator: ezetimibe and simvastatin<br>* ezetimibe/simvastatin 10/20mg tablet. Treatment time will be  40 additional weeks for a total of 64 weeks<br>Drug: Comparator: Placebo to niacin (ER)<br>* Niacin (ER) (Pbo) tablet. Treatment time will be  40 additional weeks for a total of 64 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) | Ezetimibe/simvastatin co-administered with niacin extended release compared to niacin extended release monotherapy on the percent change, from baseline in LDL-C after 24 weeks - 24 Week Measure Minus Baseline | Baseline and 24 Weeks | 
| Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) | Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in LDL-C after 24 weeks - 24 week measure minus baseline | Baseline and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) | Ezetimibe/simvastatin co-administered with niacin extended release compared to niacin extended release monotherapy on the percent change from baseline in non-HDL-C after 24 weeks - 24 week measure minus baseline | Baseline and 24 weeks | 
| Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C) | Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in HDL-C after 24 weeks - 24 week measure minus baseline | Baseline and 24 weeks | 
| Percent Change From Baseline in Triglycerides (TG) | Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in Triglycerides after 24 weeks - 24 week measure minus baseline | baseline and 24 Weeks | 
| Percent Change From Baseline in High-Density Lipoprotein-Cholesterol (HDL-C) | Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in HDL-C after 64 weeks - 64 week measure minus baseline | Baseline and 64 weeks | 
| Percent Change From Baseline in Triglycerides (TG) | Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in Triglycerides after 64 weeks - 64 week measure minus baseline | Baseline and 64 weeks | 
| Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) | Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in non-HDL-C after 64 weeks - 64 week measure minus baseline | Baseline and 64 weeks | 
| Percent Change From Baseline in Low-Density Lipoprotein-Cholesterol (LDL-C) | Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in LDL-C after 64 weeks - 64 week measure minus baseline | Baseline and 64 weeks | 
| Percent Change From Baseline in Non-High-Density Lipoprotein-Cholesterol (Non-HDL-C) | Ezetimibe/simvastatin co-administered with niacin extended release compared to ezetimibe/simvastatin monotherapy on the percent change from baseline in non-HDL-C after 24 weeks - 24 week measure minus baseline | Baseline and 24 weeks |