In patients with coronairy artery disease and a LDL-C level between 2.5 mmol/L and 5.0 mmol/L on a stable (> 4 weeks) statin starting dose (simvastatin 20 mg or atorvastatin 10 mg), investigate what the LCL-C lowering efficacy is of doubling the statin dose (to 40 mg simvastatin or 20 mg atorvastatin) versus a combination tablet of ezetimibe 10 mg plus simvastatin 20 mg once daily for 12 weeks. It is postulated that more patients reach their LDL-C treatment goal with the combination tablet compared to doubling the starting dose. Furthermore, the effect of both treatment regimens on other lipidparameters, safety and LDL-subfractions will be measured.

Condition	Intervention	Phase
Arthersclerosis	Drug: Mk0653A; ezetimibe (+) simvastatin	Phase IV

Further Study Details: 

Primary Outcomes: Switching to a combination tablet of ezetimibe 10 mg plus simvastatin 20 mg is superior to doubling the statin dose as demonstrated by the percentage of patients reaching goal after 12 weeks of treatment.
Secondary Outcomes: Switching to a combination tablet of ezetimibe 10 mg plus simvastatin 20 mg will lower LDL-C more than doubling the statin dose as demonstrated by the percentage change from treated baseline in total and LDL-cholesterol after 12 weeks of treatment.
Expected Total Enrollment:  460

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria:

• Patient is male or female  18 years of age.
• Patient is on a stable daily statin starting dose for the past 4 weeks of either: atorvastatin 10 mg or; simvastatin 20 mg
• lipid values while on statin monotherapy treatment: LDL-C level of > 2.5 mmol/L to * 5.0 mmol/L, triglycerides < 4.0 mmol/L and total cholesterol < 7.0 mmol/L.
• Patient with established coronary artery disease such as stable angina; history of myocardial infarction; history of percutaneous coronary intervention (PTCA with or without stent placement); coronary stenosis on angiography; history of unstable angina or non-Q wave myocardial infarction; history of coronary artery bypass graft surgery (CABG); positive MIBI scan. Patients have to be in a stable medical condition.

Exclusion Criteria:

• Patients in whom cholesterol lowering medication regime has changed in the previous 4 weeks.
• Patients who have been treated with any other investigational drug within 3 months of Visit 1.
• Patients who are pregnant or lactating.
• Any condition or situation which, in the opinion of the investigator, might pose a risk to the patient or interfere with participation in the study.

Please refer to this study by ClinicalTrials.gov identifier  NCT00166530

Netherlands
      Merck Sharp & Dohme B.V., Haarlem,  2031 BN,  Netherlands

Study chairs or principal investigators

Medical Monitor,  Study Director,  Merck   

Study ID Numbers:  2005_059
Last Updated:  September 13, 2005
Record first received:  September 9, 2005
ClinicalTrials.gov Identifier:  NCT00166530
Health Authority: Netherlands: Medicines Evaluation Board (MEB)
ClinicalTrials.gov processed this record on 2005-09-20