Status:
COMPLETED
The Effects of Ezetimibe/Simvastatin 10/20 mg Versus Simvastatin 40 mg in High Cholesterol and Coronary Heart Disease Study (P04039AM2)(COMPLETED)
Lead Sponsor:
Organon and Co
Collaborating Sponsors:
Schering-Plough
Conditions:
Hypercholesterolemia
Coronary Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
This study is being conducted to compare the efficacy, safety, and tolerability of ezetimibe/simvastatin 10/20 mg when administered daily versus doubling the dose of simvastatin to 40 mg in patients w...
Eligibility Criteria
Inclusion
- 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 \[PCI\] (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.
- Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
- History of myocardial infarction (heart attack).
- Subjects must be \>= 18 years and \<= 75 years of age.
- Subjects must have an LDL-C concentration \>= 2.6 mmol/L (100 mg/dL) to \<= 4.1 mmol/L (160 mg/dL) at the time of randomization (Visit 3/Baseline Visit).
- Subjects must have triglyceride concentrations of \< 3.99 mmol/L (350 mg/dL) at (Visit 3 Baseline Visit).
- Subject must be currently taking simvastatin 20 mg daily.
- Subjects must have liver transaminases (ALT \[alanine aminotransferase\], AST \[aspartate aminotransferase\]) \< 50% above the upper limit of normal, with no active liver disease, and CK (creatine kinase) \< 50% above the upper limit of normal at Visit 3 (Baseline Visit).
- Clinical laboratory tests (complete blood count \[CBC\], blood chemistries, urinalysis) must be within normal limits or clinically acceptable to the investigator at Visit 3 (Baseline Visit).
- 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.
- Subjects must report a stable weight history for at least 4 weeks prior to entry into study at Visit 3 (Baseline Visit).
- 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.
- 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 intrauterine device \[IUD\], condom in combination with spermicide) or be surgically sterilized (e.g., hysterectomy or tubal ligation).
- Subjects must be free of any clinically significant diseases other than hyperlipidemia or coronary heart disease that would interfere with study evaluations.
- 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.
Exclusion
- Subjects whose body mass index (BMI = weight \[kg\]/height2 \[m\]) is \>= 35 kg/m\^2 at Visit 3 (Baseline Visit).
- Subjects who consume \> 14 alcoholic drinks per week. (A drink is: a can of beer, glass of wine, or single measure of spirits).
- 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.
- Women who are pregnant or nursing.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2008
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00423579
Start Date
July 1 2006
End Date
March 1 2008
Last Update
May 22 2024
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