Long-Term Safety and Tolerability of Ezetimibe (SCH 58235, MK-0653) With Atovastatin (P02154, MK-0653-017)

Study Overview
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Brief Summary
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The purpose of this study is to examine the long-term safety and tolerability of ezetimibe (SCH 58235) 10 mg once daily or placebo in combination with atorvastatin (10 to 80 mg/day) for up to 12 consecutive months in participants with primary hypercholesterolemia.

Detailed Description
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This study is a long-term extension study of the protocol P00692 parent study.

Official Title
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Long-Term, Safety and Tolerability Study of SCH 58235 or Placebo in Addition to Atorvastatin in Subjects With Primary Hypercholesterolemia

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Drug: Ezetimibe
* Drug: Atovastatin
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Has successfully completed the 12-week double-blind, efficacy and safety parent study (P00692). If female, has a negative pregnancy test prior to study entry and, if of childbearing potential, agrees to practice an effective barrier method of birth control for the duration of the study and for 30 days after the last statin dose. If postmenopausal female receiving hormone therapy, a stable estrogen (ERT), estrogen/progestin (HRT) or raloxifene regimen must be maintained during the study period. Is willing to continue to follow their prescribed National Cholesterol Education Program (NCEP) Step 1 diet for the duration of the study. Exclusion Criteria: Has discontinued from the parent study (P00692) prior to study completion. Is in a situation, or has any condition which, in the opinion of the investigator may interfere with optimal participation. Is a pregnant or lactating female. Is human immunodeficiency virus (HIV) positive.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 86 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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 |
| --- | --- |
| Placebo Comparator: Placebo + Atorvastatin<br>Participants who received placebo in the parent study (P00692) receive placebo (blinded) + atorvastatin (10 mg/day; open-label) in this study. | Drug: Atovastatin<br>* Atorvastatin 10, 20, and 40 mg tablets at a daily dose of 10 to 80 mg<br>Drug: Placebo<br>* Placebo tablets matched to ezetimibe<br>|
| Experimental: Ezetimibe + Atorvastatin<br>Participants who received ezetimibe + atorvastatin, or atorvastatin alone, in the parent study (P00692) receive ezetimibe (blinded) + atorvastatin (10 mg/day; open-label) in this study. | Drug: Ezetimibe<br>* Ezetimibe 10 mg tablets<br>* Other names: SCH 58235;Drug: Atovastatin<br>* Atorvastatin 10, 20, and 40 mg tablets at a daily dose of 10 to 80 mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Experiencing ≥1 Adverse Event (AE) |  | Up to 12 months | 
| Percentage of Participants Discontinuing from Study Treatment due to an Adverse Event (AE) |  | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent Change from Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) |  | Baseline and 1.5, 3, 6, 9, and 12 months | 
| Mean Percent Change from Baseline in High-Density Lipoprotein Cholesterol (HDL-C) |  | Baseline and 1.5, 3, 6, 9, and 12 months | 
| Mean Percent Change from Baseline in Triglyceride Levels |  | Baseline and 1.5, 3, 6, 9, and 12 months | 
| Mean Percent Change from Baseline in Total Cholesterol (TC) |  | Baseline and 1.5, 3, 6, 9, and 12 months | 
| Mean Percent Change from Baseline in Calculated Low-Density Lipoprotein Cholesterol (LDL-C) |  | Baseline and 1.5, 3, 6, 9, and 12 months |