Adding Ezetimibe Tablet to Ongoing Treatment With Atorvastatin in Subjects With High Cholesterol and Multiple Coronary Heart Disease Risk Factors (Study P04060)(COMPLETED)
Condition: Hypercholesterolemia; Coronary Arteriosclerosis
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia; Arteriosclerosis; Hypercholesterolemia
Intervention: Ezetimibe; Placebo; Atorvastatin 10 mg
Intervention description: 10 mg ezetimibe, orally, daily for 6 weeks, added to ongoing treatment with 10 mg atorvastatin; 10 mg/day matching placebo to ezetimibe, orally, daily for 6 weeks, added to ongoing 10 mg atorvastatin; 10 mg/day atorvastatin, orally, (ongoing treatment in participants)
Intervention MeSH terms: Atorvastatin; Ezetimibe
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Enrollment: 22.0
Sex: All
Minimum age: 18 Years
Maximum age: 75 Years
Healthy volunteers: No

Summary:

      This study is being conducted to compare the efficacy, safety, and tolerability of ezetimibe
      10 mg coadministered with atorvastatin 10 mg versus atorvastatin 10 mg in Indonesian
      population with primary hypercholesterolemia.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have an LDL-C concentration >= 3.3 mmol/L (130 mg/dL) to <= 4.9
             mmol/L (190 mg/dL) using the Freidewald calculation.

          -  Participants must have triglyceride concentrations of < 3.99 mmol/L (350 mg/dL).

          -  Participants must have two or more coronary heart disease risk factors listed below:

               -  Current cigarette smoking

               -  Hypertension (BP >= 140/90 mmHg or on antihypertensive medication)

               -  Low HDL cholesterol (< 40 mg/dL)

               -  Family history of premature CHD (CHD in male first degree relative < 55 years;
                  CHD in female first degree relative < 65 years)

               -  Age (Men >= 45 years; women >= 55 years)

          -  Participant must be currently taking atorvastatin 10 mg daily and by history has taken
             80% of daily doses for the 6 weeks prior to participating.

          -  Participants must have liver transaminases (ALT, AST) < 50% above the upper limit of
             normal, with no active liver disease, and CK < 50% above the upper limit of normal.

          -  Participants must have maintained a cholesterol lowering diet, exercise program, and
             stable weight for at least 4 weeks prior to the study and be willing to continue the
             same diet and exercise program during the study.

          -  Women receiving hormonal therapy, including hormone replacement, any estrogen
             antagonist/agonist, or oral contraceptives, must have been maintained on a stable dose
             and regimen for at least 8 weeks and be willing to continue the same regimen for the
             duration of the study.

        Exclusion Criteria:

          -  Participants who meet any of the following criteria will be excluded:

          -  Body mass index (BMI = weight [kg]/height**2[m]) is >= 30 Kg/m**2.

          -  Consume > 14 alcoholic drinks per week.

          -  Women who are pregnant or nursing.

          -  Congestive heart failure defined by NYHA as Class III or IV.

          -  Uncontrolled cardiac arrhythmia.

          -  Coronary heart disease (CHD).

          -  Unstable or severe peripheral artery disease within 3 months of participating

          -  Uncontrolled hypertension (treated or untreated) with systolic blood pressure > 160 mm
             Hg or diastolic > 100 mm Hg.

          -  Type I or Type II diabetes mellitus.

          -  Secondary causes of hyperlipidemia, such as secondary hypercholesterolemia due to
             hypothyroidism.

          -  Impaired renal function (creatinine > 2.0 mg/dL) or nephrotic syndrome.

          -  Known HIV positive.

          -  Cancer within the past 5 years (except for successfully treated basal and squamous
             cell carcinomas).

          -  History of mental instability, drug/alcohol abuse within the past 5 years, or major
             psychiatric illness not adequately controlled and stable on pharmacotherapy.

          -  Participants who are on any of the following concomitant medications:

          -  Participants who are on medications that are potent inhibitors of CYP3A4, including
             cyclosporine, systemic itraconazole, fluconazole, and ketoconazole, erythromycin or
             clarithromycin, nefazodone, mibefradil, protease inhibitors and large amounts of
             grapefruit juice (> 1 quart/day).

          -  Participants who are on lipid-lowering agents (other atorvastatin): niacin (> 200
             mg/day)

          -  Participants who are on over the counter lipid lowering agents such as fish oils,
             garlic and cholestin

          -  Participants who are on oral corticosteroids, unless used as replacement therapy for
             pituitary/adrenal disease and the subject is on a stable regimen for at least 6 weeks.

          -  Participants who are currently using psyllium, other fiber-based laxatives, and/or any
             other OTC therapy known to affect serum lipid levels (phytosterol margarine), and have
             not been on a stable regimen for at least 5 weeks and who do not agree to remain on
             this regimen throughout the study.

          -  Participant who are currently using orlistat or sibutramine.