A Study to Determine the Number of Patients Who Reach Optimal Cholesterol Levels on Each of Three Different Treatments (0653A-121)

Study Overview
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Brief Summary
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To evaluate the percentage of patients with either established cardiovascular disease (CVD), at high risk of developing CVD or with diabetes who are on simvastatin 40mg, with fasting LDL-C > 2mmol/l, who are able to attain the recommended LDL-C target of < 2mmol/l following 6 weeks treatment with either ezetimibe/simvastatin 10/40mg, atorvastatin 40mg or rosuvastatin 10mg.

Official Title
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A MC, DB, Rand, Study to Evaluate Efficacy, Safety and Tolerability of Eze/Simva 10/40 mg, Atorva 40 mg, Rosuva 10 mg in Achieving LDL-C <2 mmol/l in Pts With CVD...on Simva 40 mg With LDL-C ³2 mmol/l

Conditions
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Hypercholesterolemia

Intervention / Treatment
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* Drug: ezetimibe (+) simvastatin
* Drug: Comparator: atorvastatin
* Drug: Comparator: rosuvastatin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient Is Male Or Female And Aged Over 18 Patient Provides Written Informed Consent Patient Has A Fasting Ldl-C Level >2mmol/L At Both Visit 1 And Again At Visit 2 Patient Has Established Cvd, Diabetes Or At High Risk Of Cvd (>20 % Risk Over 10 Years, Framingham Scale) Patient Has Taken Simvastatin 40mg Continuously For The Past 6 Weeks Patient Has A Fasting Triglyceride Level Of <3.7mmol/L Patient Has Hba1c <9% At Visit 1 Patient Is 75% Compliant With Medication Between Visit 1 And Visit 2 Exclusion Criteria: Patient Is Hypersensitive To Any Of The Study Medications Or Their Components Patient Has A History Of, Or Active Liver Disease (Persistent Elevation Of Alt / Ast (>3xuln) Patient Is Pregnant, Lactating, Or A Female Patient Of Childbearing Potential Not Using Adequate Contraception Patient Has Severe Renal Impairment: Creatinine Clearance <30ml/Min (Cockcroft-Gault Equation) (In Patients With Moderate Renal Impairment: <60ml/Min, The Dose Of Rosuvastatin Will Be 5mg In Line With The Spc) Patient Has Uncontrolled Endocrine Or Metabolic Disease Known To Influence Serum Lipids Or Lipoproteins (I.E. Secondary Causes Of Hyperlipidaemia Such As Hypothyroidism Or Hyperthyroidism) Patient Has A Recent History Of, Or Current, Alcohol Abuse Patient Has Ck >10 X Uln At Visit 1 Or Visit 2 Patient Has Fasting Ldl-C >4.2mmol/L Patient Has Any Acute Or Serious Condition, Or History Suggestive Of Myopathy Or Predisposing To The Development Of Renal Failure Secondary To Rhabdomyolysis (E.G. Sepsis, Hypotension, Major Surgery, Trauma, Severe Metabolic, Severe Endocrine And Electrolyte Disorders Or Uncontrolled Seizures)

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Experimental: 1<br>Arm 1: Drug | Drug: ezetimibe (+) simvastatin<br>* ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally, cholesterol lowering medication.<br>* Other names: MK0653A;|
| Active Comparator: 2<br>Arm 2: Active comparator | Drug: Comparator: atorvastatin<br>* atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally<br>* Other names: atorvastatin;|
| Active Comparator: 3<br>Arm 3: Active comparator | Drug: Comparator: rosuvastatin<br>* rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally.<br>* Other names: rosuvastatin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Patients Achieving a Target of Fasting LDL-C of <2mmol/l at Study End | Fasting LDL-C was the primary efficacy variable. The primary efficacy analysis was based on the proportion of patients achieving a target of <2mmol/l in fasting LDL-C at study end. | 6 Weeks |