Begin With The Right Patients With Dual-Inhibition Action Therapy Through Vytorin for Newly Diagnosed Dyslipidemia Patients (0653A-172)(COMPLETED)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia; Dyslipidemias
Intervention: ezetimibe (+) simvastatin
Intervention description: Vytorin 10/20 (ezetimibe 10 mg /simvastatin20 mg) tablet once daily consecutively for 6 weeks.
Intervention MeSH terms: Simvastatin; Ezetimibe
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 173.0
Sex: All
Minimum age: 20 Years
Maximum age: 79 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to determine the safety and tolerability of
      ezetimibe/simvastatin in patients newly diagnosed with dyslipidemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male Or Female Patient, 20 Through 79 Years Of Age

          -  Newly Diagnosed Dyslipidemia Patients Including: 1) Intermediate Risk (>2 Risk
             Factors) With Total Cholesterol level above 200 mg/dL Or Low Density Lipoprotein-C
             (LDL-C) level> 130 mg/dLwho failed a 3-Month diet control period, or 2) High Risk
             Patients with history of Coronary artery disease Or diabetes and having a total
             Cholesterol> 200 mg/dL Or LDL-C level> 130 mg/dL

          -  Willing To Follow An National Cholesterol Education Program (NCEP) Therapeutic
             Lifestyle Changes (TLC) Or Similar Cholesterol-Lowering Diet For The Duration Of The
             Study

          -  Female Patients Receiving Hormone Therapy (Including Hormone Replacement Therapy, And
             Estrogen Antagonist/Agonist, Or Oral Contraceptives) If Maintained On A Stable Dose
             And Regimen For At Least 8 Weeks Prior To Visit 1 And If Willing To Continue The Same
             Regimen Throughout The Study

        Exclusion Criteria:

          -  Women Who Are Pregnant Or Lactating

          -  Has A History Of Cancer Within The Past 5 Years (Except For Dermatological Basal Cell
             Or Squamous Cell Carcinoma)

          -  Patients Hypersensitive To Simvastatin Or Ezetimibe

          -  Any Condition Or Situation Which, In The Opinion Of The Investigator, Might Pose A
             Risk To The Patient Or Confound The Results Of The Study

          -  History Of Mental Instability, Drug/Alcohol Abuse Within The Past 5 Years, Or Major
             Psychiatric Illness Not Adequately Controlled By Pharmacotherapy

          -  Nephritic Syndrome Or Other Clinically Significant Renal Disease Resulting In Impaired
             Renal Function, Defined As Serum Creatinine ≧ 1.5 Mg/Dl

          -  Alanine Aminotransferase (ALT), And Aspartate Aminotransferase (AST) above 1.5 X Upper
             Limit Of Normal (Uln) Or With Active Liver Disease

          -  Congestive Heart Failure (New York Heart Association (NYHA) III Or IV), Uncontrolled
             Cardiac Arrythmias, Uncontrolled Hypertension (Systolic Blood Pressure (SBP) >160 mm
             Hg Or Diastolic Blood Pressure (DBP) >100 mm Hg), Unstable Angina Pectoris Or Severe
             Peripheral Artery Disease, Or Experienced Myocardial Infarction, Coronary Artery
             Bypass Surgery, Angioplasty Within 3 Months

          -  Unstable Diabetes Mellitus Patient (Hemoglobin A1c (HbA1c) > 8.5%) Or Newly Diagnosed
             (Within 3 Months) Or A Change In Anti-Diabetic Pharmacotherapy Within 3 Months Of
             Screening

          -  Secondary Dyslipidemia (E.G., Hypothyroidism)

          -  Disorders Of The Hematologic, Digestive, Or Central Nervous Systems Including
             Cerebrovascular Disease And Degenerative Disease That Would Limit Study Evaluation Or
             Participation

          -  History Of Active Or Chronic Hepatobiliary Disease Or Cholelithiasis But Have Not
             Undergone Cholecystectomy