Effectiveness and Safety of Ezetimibe Added to Atorvastatin in Patients With High Cholesterol and Coronary Heart Disease (Study P03740)
Condition: Hypercholesterolemia; Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multicenter, randomized, parallel group, placebo controlled study designed to
      evaluate the efficacy, safety, and tolerability of ezetimibe added to ongoing atorvastatin
      therapy compared with ongoing atorvastatin treatment alone. This study will involve subjects
      with primary hypercholesterolemia and coronary heart disease (CHD) who are currently being
      treated with atorvastatin and who would benefit from additional reduction in low-density
      lipoprotein cholesterol (LDL-C).
    

Detailed description: 
      This multicenter, randomized, parallel groups, placebo-study is designed for subjects with
      primary hypercholesterolemia [plasma LDL-C concentrations between >= 2.6 mmol/L (100 mg/dL)
      to <= 4.1 mmol/L (160 mg/dL) and triglyceride concentrations of < 3.99 mmol/L (350 mg/dL) and
      coronary heart disease who are currently being treated with atorvastatin 10 mg and would
      benefit from additional reduction in LDL-C.

      This study will assess whether the daily co-administration of ezetimibe 10 mg to ongoing
      treatment with atorvastatin 10 mg will be more effective than treatment with atorvastatin 10
      mg alone in further reducing LDL-C concentrations and in achieving LDL-C target goal as
      defined by the ESC or National Cholesterol Education Program (NCEP) guidelines at the time of
      database lock.

      The primary objective is to compare the efficacy of ezetimibe 10 mg added daily to ongoing
      treatment with atorvastatin 10 mg versus ezetimibe placebo added daily to ongoing treatment
      with atorvastatin 10 mg in reducing the concentration of LDL-C at endpoint after 6 weeks of
      treatment.

      The secondary objective is to compare the efficacy of ezetimibe 10 mg added to ongoing
      treatment with atorvastatin 10 mg daily versus ezetimibe placebo added to ongoing treatment
      with atorvastatin 10 mg daily after 6 weeks of treatment with respect to:

        -  The percentage of subjects who achieve the target LDL-C goal as defined by the ESC or
           NCEP guidelines at the time of database lock.

        -  Change in the concentrations of total cholesterol, HDL-C and triglycerides.

        -  Safety and tolerability. Approximately 200 subjects will be enrolled into the study to
           insure that at least 160 subjects complete the study. Each site will enroll
           approximately 20 subjects for a total of approximately 200 subjects.

      The duration of the study for each subject will be approximately 7 weeks. Each subject will
      be scheduled for 3-4 study visits. Visits 1 and 2 are screening visits; these visits may be
      combined. At Visit 3, those subjects who meet the enrollment criteria will be randomized to
      one of two treatment groups: ezetimibe 10 mg or ezetimibe placebo to be taken with ongoing
      open-label atorvastatin 10 mg/day. Randomization will be stratified based on the LDL-C level
      at Visit 3: < 3.3 mmol/L (130 mg/dL) or >= 3.3 mmol/L (130 mg/dL). Subjects will be treated
      for 6 weeks and then return for a final visit, Visit 4.
    

Intervention name(s): ezetimibe; placebo
Intervention type(s): Drug; Drug
Intervention description(s): ezetimibe 10 mg tablets, one tablet taken daily with atorvastatin 10 mg daily for 6 weeks; placebo tablets matched to ezetimibe, one tablet taken daily with atorvastatin 10 mg daily for 6 weeks
Other intervention name(s): Zetia, SCH 58235
Intervention MeSH terms: Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ezetimibe; atorvastatin; hypercholesterolemia; coronary heart disease