The goal of this clinical trial is to test whether one pill that combines ezetimibe, rosuvastatin, and amlodipine can safely lower cholesterol and blood pressure in Korean adults with high blood pressure and high cholesterol.
Amlodipine is a calcium channel blocker used for the treatment of hypertension. Rosuvastatin is a statin that inhibits HMG-CoA reductase and is widely used for the treatment of hypercholesterolemia. Ezetimibe is a lipid-lowering agent that inhibits intestinal cholesterol absorption and is commonly used in combination with statins. This multicenter, randomized, double-blind, active-controlled, phase 3 clinical trial evaluates the efficacy and safety of a fixed-dose combination of ezetimibe, rosuvastatin, and amlodipine in Korean adults with essential hypertension and primary hypercholesterolemia. Following a run-in period that includes therapeutic lifestyle modification, participants are randomized in a 1:1:1 ratio to receive ezetimibe/rosuvastatin/amlodipine 10/20/10 mg or amlodipine 10 mg, or ezetimibe/rosuvastatin 10/20 mg for 8 weeks. A total of 163 participants were enrolled across 21 study sites. Low-density lipoprotein cholesterol (LDL-C) levels and mean sitting systolic blood pressure (MSSBP) are assessed at Weeks 4 and 8. The primary efficacy endpoints are the percent change in LDL-C from baseline at Week 8 and the change in MSSBP from baseline at Week 8. Secondary endpoints include changes in total cholesterol, high-density lipoprotein cholesterol (HDL-C), triglycerides, non-HDL-C, and apolipoprotein B (ApoB).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
163
Oral tablet containing amlodipine 10 mg administered for 8 weeks.
Fixed-dose combination oral tablet containing ezetimibe 10 mg and rosuvastatin 20 mg administered for 8 weeks.
Placebo for ezetimibe/rosuvastatin (10mg/20mg)
Korea University Ansan Hospital
Ansan, South Korea
Hallym University Sacred Heart Hospital
Anyang, South Korea
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8 in Treatment Group and Control Group 1
Percent change from baseline in LDL-C level.
Time frame: Baseline, Week 8
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 in Treatment Group and Control Group 2
Change from baseline in mean sitting systolic blood pressure. Change is calculated as the Week 8 value minus the baseline value.
Time frame: Baseline, Week 8
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 4 in the Treatment Group and Control Group 1
Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 4 in the treatment group and control group 1.
Time frame: Baseline, Week 4
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 4 in the Treatment Group and Control Group 2
Change from baseline in mean sitting systolic blood pressure (MSSBP) at Week 4 in the treatment group and control group 2.
Time frame: Baseline, Week 4
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Weeks 4 and 8 in the Treatment Group and Control Group 1
Change from baseline in mean sitting systolic blood pressure (MSSBP) at Weeks 4 and 8 in the treatment group and control group 1.
Time frame: Baseline, Week 4, Week 8
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Weeks 4 and 8 in the Treatment Group and Control Group 2
Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Weeks 4 and 8 in the treatment group and control group 2.
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Placebo for amlodipine (10mg)
Kosin University Gospel Hospital
Busan, South Korea
Pusan National University Hospital
Busan, South Korea
Dankook University Hospital
Cheonan, South Korea
Daegu Catholic University Medical Center
Daegu, South Korea
Keimyung University Dongsan Medical Center
Daegu, South Korea
Yeungnam University Hospital
Daegu, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Gachon University Gil Medical Center
Incheon, South Korea
...and 11 more locations
Time frame: Baseline, Week 4, Week 8
Percent Change From Baseline in TC, TG, HDL-C, non-HDL-C, and Apo B at Weeks 4 and 8 in the Treatment Group, Control Group 1 and Control Group 2
Percent change from baseline in total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), non-high-density lipoprotein cholesterol (non-HDL-C), and apolipoprotein B (Apo B) at Weeks 4 and 8 in the treatment group, control group 1, and control group 2.
Time frame: Baseline, Week 4, Week 8
Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSDBP) at Weeks 4 and 8 in the Treatment Group, Control Group 1, and Control Group 2
Change from baseline in mean sitting diastolic blood pressure (MSDBP) at Weeks 4 and 8 in the treatment group, control group 1, and control group 2.
Time frame: Baseline, Week 4, Week 8
Proportion of Participants Achieving Target Blood Pressure at Weeks 4 and 8 in the Treatment Group, Control Group 1, and Control Group 2
Proportion of participants who achieved target blood pressure at Weeks 4 and 8 in the treatment group, control group 1, and control group 2. Target blood pressure is defined as MSSBP/MSDBP \<140/90 mmHg. For participants with high-risk diabetes mellitus, chronic kidney disease with diabetes mellitus or albuminuria, concomitant cardiovascular disease, or high-risk hypertension, target blood pressure is defined as MSSBP/MSDBP \<130/80 mmHg.
Time frame: Week 4, Week 8
Proportion of Participants Achieving Target Low-Density Lipoprotein Cholesterol (LDL-C) at Weeks 4 and 8 in the Treatment Group, Control Group 1, and Control Group 2
Proportion of participants who achieved target low-density lipoprotein cholesterol (LDL-C) at Weeks 4 and 8 in the treatment group, control group 1, and control group 2. Target LDL-C is defined according to cardiovascular risk category as follows: very high-risk, \<70 mg/dL; high-risk, \<100 mg/dL; moderate-risk, \<130 mg/dL; and low-risk, \<160 mg/dL.
Time frame: Week 4, Week 8