The Safety & Efficacy of Combination BMS-201038 (AEGR-733) & Ezetimibe vs. Monotherapy in Moderate Hypercholesterolemia
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Intervention: BMS-201038 (AEGR-733); Ezetimibe
Intervention MeSH terms: Ezetimibe
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Enrollment: 60.0
Sex: All
Minimum age: 18 Years
Maximum age: 70 Years
Healthy volunteers: No
Keywords: Cholesterol

Summary:

      The main objectives of this study are to evaluate the efficacy and safety of combination
      therapy BMS-201038 (AEGR-733) plus ezetimibe vs. each agent given alone on LDL cholesterol
      and other lipoproteins over 12 weeks of therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Men and women between the ages of 18 and 70 years .

          2. For subjects with 0 to 1 risk factor (cigarette smoking, hypertension (BP > 140/90 or
             on antihypertensive medication), low HDL (<40mg/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): Baseline mean LDL-C must be >160 and
             <250 mg/dl as determined by the arithmetic mean of measures taken at visit 1 and 2.
             Fasting mean TGs should be <400 mg/dl.

          3. For subjects with 2 or more risk factors (cigarette smoking, hypertension (BP > 140/90
             or on antihypertensive medication), low HDL (<40mg/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) or prior stable CHD: Baseline mean
             LDL-C must be >130 and <250 mg/dl as determined by the arithmetic mean of measures
             taken at visit 1 and 2. Fasting mean TGs should be <400 mg/dl.

          4. Able to understand and willing to comply with all study requirements, particularly the
             study drug regimen.

          5. Able to understand and willing to sign the Informed Consent Form.

        Exclusion Criteria:

          1. Women who are pregnant or lactating or who are planning to become pregnant or women of
             child bearing potential who have not successfully been using acceptable contraceptive
             methods over the previous 3 months (e.g. intrauterine device and barrier method plus
             spermicide).

          2. Uncontrolled hypertension defined as: systolic blood pressure > 180 mmHg, diastolic
             blood pressure > 95 mmHg

          3. History of chronic renal insufficiency (serum creatinine >2.5 mg/dL)

          4. History of liver disease or transaminases above 1.5 X ULN at screening

          5. Any major surgical procedure occurring less than 3 months prior to the screening visit

          6. Cardiac insufficiency defined by the NYHA classification as functional Class II-Class
             IV

          7. History of a malignancy (other than basal cell or squamous cell carcinoma of the skin
             that has been removed) within the previous 5 years

          8. Participation in an investigational drug study within 6 weeks prior to the screening
             visit.

          9. Serious or unstable medical or psychological conditions that, in the opinion of the
             investigator, would compromise the subject's safety or successful participation in the
             study.

         10. Regular alcohol use > 1 drink per day

         11. Regular consumers of grapefruit juice, or currently taking medications known to be
             metabolized by CYP 3A4 (cyclosporine, itraconazole, ketoconazole, erythromycin,
             clarithromycin, telithromycin, HIV protease inhibitors, and nefazodone)

         12. Other lipid-lowering medications (washouts will be permitted)

         13. Acute CVD (CVD event within the previous 6 months)

         14. Diabetes Mellitus