Comparison of Co-administration of Ezetimibe Plus Simvastatin Versus Simvastatin Alone in Primary… (NCT00651274) | Clinical Trial Compass
CompletedPhase 4
Comparison of Co-administration of Ezetimibe Plus Simvastatin Versus Simvastatin Alone in Primary Hypercholesterolemia (P03476)
144 participantsStarted 2003-04-01
Plain-language summary
This study will assess whether the daily co-administration of ezetimibe 10 mg with ongoing treatment of simvastatin 20 mg will be more effective than treatment with simvastatin 20 mg alone in further reducing LDL-C concentrations.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Subjects must demonstrate their willingness to participate in the study and comply with its procedures by signing a written informed consent.
* 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) using the Friedewald calculation available 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).
* 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 PTCA 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.
* Subject must be currently taking simvastatin 20 mg daily and by history has taken 80% of daily evening doses for the preceding 6 weeks prior to Visit 3 (Baseline Visit).
* 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).
* Clinical laboratory tests (CBC, blood chemis…
What they're measuring
1
Percent change from baseline in LDL-cholesterol with ezetimibe added to simvastatin versus continued simvastatin alone.