Hypercholesterolemia MedDRA version: 6.1 Level: PT Classification code 10020603
Conditions
Interventions
Product Name: VYTORIN
Product Code: SCH 58235
Pharmaceutical Form: Tablet
INN or Proposed INN: Ezetimibe
Concentration unit: mg milligra
Sponsors
SCHERING-PLOUGH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects must have documented coronary heart disease CHD . For the purposes of this study, CHD will include one or more of the following features documented stable angina with evidence of ischemia on exercise testing ; history of myocardial infarction; history of percutaneous coronary intervention primarily PCI with or without stent placement ; symptomatic peripheral vascular disease claudication ; documented history of atherothrombotic cerebrovascular disease; and/or documented history of unstable angina or non-Q wave myocardial infarction. 2. Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent. 3. Subjects must be 18 years and 75 years of age. 4. Subjects must have an LDL-C concentration 2.6 mmol/L 100 mg/dL to 4.1 mmol/L 160 mg/dL using the Friedewald calculation see Section 8.8 available at the time of randomization Visit 3 Baseline Visit . 5. Subjects must have triglyceride concentrations of 3.99 mmol/L 350 mg/dL at Visit 3 Baseline Visit . 6. Subject must be currently taking simvastatin 20 mg daily and by history has taken 80 of daily evening doses for the 6 weeks prior to Visit 3 Baseline Visit . 7. Subjects 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 at Visit 3 Baseline Visit . 8. Clinical laboratory tests CBC, blood chemistries, urinalysis must be within normal limits or clinically acceptable to the investigator at Visit 3 Baseline Visit . 9. Subjects must have maintained a cholesterol lowering diet and exercise program for at least 4 weeks prior to the study and be willing to continue the same diet and exercise program during the study. 10. Subjects must report a stable weight history for at least 4 weeks prior to entry into study at Visit 3 Baseline Visit . 11. 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. 12. Women of childbearing potential includes women who are less than 1 year postmenopausal and women who become sexually active must be using an acceptable method of birth control e.g., hormonal contraceptive, medically prescribed IUD, condom in combination with spermicide or be surgically sterilized e.g., hysterectomy or tubal ligation . 13. Subjects must be free of any clinically significant diseases other than hyperlipidemia or coronary heart disease that would interfere with study evaluations. 14. Subjects must understand and be able to adhere to the dosing and visit schedules, and must agree to remain on their cholesterol-lowering diet and their exercise regimen for the duration of the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Subjects whose body mass index BMI weight kg /height2 m is 35 Kg/m2 at Visit 3 Baseline Visit . 2. Subjects who consume 14 alcoholic drinks per week. A drink is a can of beer, glass of wine, or single measure of spirits . 3. Any condition or situation which, in the opinion of the investigator, might pose a risk to the subject or interfere with participation in the study. 4. Women who are pregnant or nursing.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy of ezetimibe/simvastatin 10/20 mg when administrated daily versus doubling the dose of simvastatin to 40 mg in reducing the concentration of LDL-C at endpoint after 6 weeks of treatment.;Secondary Objective: To compare the efficacy of ezetimibe/simvastatin 10/20 mg when administrated daily versus doubling the dose of simvastatin to 40 mg at endpoint after 6 weeks of treatment with respect to 1. the percentage of subjects who achieve the target LDL-C goal as defined by the NCEP III guidelines 2.6 mmol/L; 100 mg/dL . 2. percent change from baseline in the concentrations of total cholesterol, HDL-C , triglycerides and C-reactive protein. 3. safety and tolerability.;Primary end point(s): To compare the efficacy of ezetimibe/simvastatin 10/20 mg when administrated daily versus doubling the dose of simvastatin to 40 mg in reducing the concentration of LDL-C at endpoint after 6 weeks of treatment. | — |
Countries
Italy
Outcome results
None listed