The purpose of this study is to determine the safety and tolerability of ezetimibe/simvastatin in patients newly diagnosed with dyslipidemia.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
173
Vytorin 10/20 (ezetimibe 10 mg /simvastatin20 mg) tablet once daily consecutively for 6 weeks.
The Percentage of Participants Achieving Low Density Lipoprotein-C (LDL-C) Treatment Goal After 6-week Treatment.
Goal attainment percentage of LDL-C after 6-week treatment. LDL-C goal attainment was based on National Cholesterol Education program (NCEP) Adult Treatment Panel (ATP) III guidelines (2004). Newly Diagnosed Dyslipidemia Patients Including: 1)Intermediate Risk (\>2 Risk Factors) with Total Cholesterol above 200 mg/dL or Low Density Lipoprotein C (LDL-C) level \>130 who failed a 3-month diet control period, or 2) high risk patients with a history of coronary artery disease or diabetes having a total cholesterol \>200 mg/dl or LDL-C level \>130 mg/dl.
Time frame: Baseline and week 6
The Percentage of Participants Achieving Low Density Lipoprotein-C (LDL-C) Treatment Goal After 12-week Treatment.
Goal attainment percentage of LDL-C after 12-week treatment. LDL-C goal attainment was based on National Cholesterol Education program (NCEP) Adult Treatment Panel (ATP) III guidelines (2004). Newly Diagnosed Dyslipidemia Patients Including: 1)Intermediate Risk (\>2 Risk Factors) with Total Cholesterol above 200 mg/dL or Low Density Lipoprotein C (LDL-C) level \>130 who failed a 3-month diet control period, or 2) high risk patients with a history of coronary artery disease or diabetes having a total cholesterol \>200 mg/dl or LDL-C level \>130 mg/dl.
Time frame: Baseline and week 12
Mean Percent Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 6
Time frame: Baseline and week 6
Mean Percent Change From Baseline of Total-Cholesterol (TC) at Week 6
Time frame: Baseline and week 6
Mean Percent Change From Baseline of High Density Lipoprotein-C (HDL-C) at Week 6
Time frame: Baseline and week 6
Mean Percent Change of Triglycerides From Baseline at Week 6
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Time frame: Baseline and week 6
Mean Percent Change From Baseline of Low Density Lipoprotein-Cholesterol (LDL-C) at Week 12
Time frame: Baseline and week 12
Mean Percent Change From Baseline of Total-Cholesterol (TC) at Week 12
Time frame: Baseline and week 12
Mean Percent Change From Baseline of High Density Lipoprotein-C (HDL-C) at Week 12
Time frame: Baseline and week 12
Mean Percent Change of Triglycerides From Baseline at Week 12
Time frame: Baseline and week 12