A Study to Determine the Number of Patients Who Reach Optimal Cholesterol Levels on Each of Three Different Treatments (0653A-121)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: ezetimibe (+) simvastatin; Comparator: atorvastatin; Comparator: rosuvastatin
Intervention description: ezetimibe (+) simvastatin 10/40mg. once daily tablet formulation, all tablet form, taken orally, cholesterol lowering medication.; atorvastatin 40mg. once daily tablet formulation, all tablet form, taken orally; rosuvastatin 10 mg. once daily tablet formulation, all tablet form, taken orally.
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium; Simvastatin; Ezetimibe
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 786.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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)