Efficacy and Safety of Ezetimibe/Rosuvastatin and Amlodipine Patients With High Blood Pressure and High Cholesterol

NCT07564726 | Completed Phase 3 DMC

• 1 other identifier: CTP-EAR 3.1
• Study Type: interventional
• Target: 163
• Locations: 1 country
• Sites: 21

Brief Summary

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.

Conditions

Hypertension; Hypercholesterolemia

Keywords

low-density lipoprotein cholesterol (LDL-C); mean sitting systolic blood pressure (MSSBP); Amlodipine; Rosuvastatin; Ezetimibe; phase 3; multi-center; randomized; double-blind; active-controlled; efficacy and safety; combination therapy; essential hypertension; primary hypercholesterolemia

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline, Week 8

Secondary Outcomes (8)

• Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 4 in the Treatment Group and Control Group 1

  Baseline, Week 4

• Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 4 in the Treatment Group and Control Group 2

  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

  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

  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

  Baseline, Week 4, Week 8

Study Arms (3)

Treatment group

EXPERIMENTAL

Drug: Amlodipine; Drug: Ezetimibe/Rosuvastatin

Control group 1

ACTIVE COMPARATOR

Drug: Amlodipine; Drug: Ezetimibe/Rosuvastatin Placebo

Control group 2

ACTIVE COMPARATOR

Drug: Ezetimibe/Rosuvastatin; Drug: Amlodipine Placebo

Interventions

Amlodipine DRUG

Oral tablet containing amlodipine 10 mg administered for 8 weeks.

Control group 1; Treatment group

Ezetimibe/Rosuvastatin DRUG

Fixed-dose combination oral tablet containing ezetimibe 10 mg and rosuvastatin 20 mg administered for 8 weeks.

Control group 2; Treatment group

Ezetimibe/Rosuvastatin Placebo DRUG

Placebo for ezetimibe/rosuvastatin (10mg/20mg)

Control group 1

Amlodipine Placebo DRUG

Placebo for amlodipine (10mg)

Control group 2

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 19 years or older at the time of written informed consent
• Diagnosed with essential hypertension and primary hypercholesterolemia, or currently receiving antihypertensive and/or lipid-lowering medication after such diagnosis
• If receiving antihypertensive and/or lipid-lowering therapy at screening, judged by the investigator to be medically appropriate for discontinuation of prior therapy during the clinical trial period
• Able and willing to voluntarily sign the written informed consent form after receiving an explanation of the purpose, methods, and expected effects of the study
• Mean sitting systolic blood pressure (MSSBP) of at least 140 mmHg and less than 180 mmHg, and mean sitting diastolic blood pressure (MSDBP) less than 110 mmHg
• Completion of at least 4 weeks of therapeutic lifestyle modification before administration of the investigational product
• After at least 4 weeks of therapeutic lifestyle modification, fasting LDL-C meeting one of the following criteria:
• Very high-risk group: LDL-C 70 mg/dL or higher in participants with coronary artery disease, atherosclerotic ischemic stroke or transient ischemic attack, or peripheral arterial disease
• High-risk group: LDL-C 100 mg/dL or higher in participants with carotid artery disease, abdominal aneurysm, or diabetes mellitus
• Moderate-risk group: LDL-C 130 mg/dL or higher in participants with 2 or more major risk factors
• Low-risk group: LDL-C 160 mg/dL or higher in participants with 1 or fewer major risk factors
• Fasting triglycerides less than 400 mg/dL and LDL-C 250 mg/dL or lower

You may not qualify if:

• MSSBP ≥ 180 mmHg or MSDBP ≥ 110 mmHg at screening or randomization
• Difference between arms at screening of MSSBP ≥ 20 mmHg and MSDBP ≥ 10 mmHg
• History of secondary hypertension or medical history suggestive of secondary hypertension, including coarctation of the aorta, hyperaldosteronism, renal artery stenosis, Cushing disease, pheochromocytoma, or polycystic kidney disease, etc.
• Symptomatic orthostatic hypotension, defined as a decrease in systolic blood pressure of 20 mmHg or more or diastolic blood pressure of 10 mmHg or more on standing compared with sitting or supine blood pressure
• Subjects with secondary dyslipidemia
• Severe cardiac disease, including congestive heart failure (NYHA class III or IV), clinically significant arrhythmia, hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, or hemodynamically significant stenosis of the aortic or mitral valve
• Unstable angina, myocardial infarction, transient ischemic attack, cerebrovascular disease, coronary artery bypass grafting, or percutaneous coronary intervention within 6 months prior to screening
• Retinal hemorrhage, including visual impairment, within 6 months prior to screening
• Chronic inflammatory disease requiring treatment (e.g., rheumatoid arthritis), or wasting disease, autoimmune disease, or connective tissue disease
• Endocrine or metabolic disease known to affect serum lipids or lipoproteins, including uncontrolled diabetes mellitus (HbA1c \> 9%) or uncontrolled thyroid dysfunction (TSH \> 1.5 times the upper limit of normal)
• Severe renal or hepatic impairment, defined as AST or ALT \> 3 times the upper limit of normal, or serum creatinine \> 1.5 times the upper limit of normal
• History of myopathy or rhabdomyolysis, or creatine kinase (CK) \> 2 times the upper limit of normal
• Patients who received, before study participation, treatment with medications that may affect lipid levels, including bile acid sequestrants, anti-obesity medications, fibrates, niacin, or systemic steroid therapy; however, participation is permitted if the relevant washout period has been completed.
• Need for treatment with protocol-prohibited concomitant medications during the study period
• History of hypersensitivity to ezetimibe, rosuvastatin, amlodipine, or related drug classes

Sponsors & Collaborators

• Celltrion Pharm, Inc.: lead

Study Sites (21)

Korea University Ansan Hospital

Ansan, South Korea

Location

Hallym University Sacred Heart Hospital

Anyang, South Korea

Location

Kosin University Gospel Hospital

Busan, South Korea

Location

Pusan National University Hospital

Busan, South Korea

Location

Dankook University Hospital

Cheonan, South Korea

Location

Daegu Catholic University Medical Center

Daegu, South Korea

Location

Keimyung University Dongsan Medical Center

Daegu, South Korea

Location

Yeungnam University Hospital

Daegu, South Korea

Location

Chonnam National University Hospital

Gwangju, South Korea

Location

Gachon University Gil Medical Center

Incheon, South Korea

Location

Jeonbuk National University Hospital

Jeonju, South Korea

Location

Cha University Bundang Medical Center

Seongnam, South Korea

Location

Asan Medical Center

Seoul, South Korea

Location

Kangbuk Samsung Hospital

Seoul, South Korea

Location

Korea University Anam Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Nowon Eulji Medical Center, Eulji University

Seoul, South Korea

Location

Severance Hospital

Seoul, South Korea

Location

The Catholic University of Korea Seoul St. Mary's Hospital

Seoul, South Korea

Location

The Catholic University of Korea Uijeongbu St. Mary's Hospital

Uijeongbu-si, South Korea

Location

Uijeongbu Eulji Medical Center, Eulji University

Uijeongbu-si, South Korea

Location

MeSH Terms

Conditions

Hypertension; Hypercholesterolemia; Essential Hypertension

Interventions

Amlodipine; Ezetimibe; Rosuvastatin Calcium

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Azetidines; Azetines; Sulfonamides; Amides; Organic Chemicals; Fluorobenzenes; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrimidines

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigational Product supplier, Clinical trial pharmacist
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: May 4, 2026
• Study Start: August 5, 2022
• Primary Completion: February 13, 2024
• Study Completion: February 13, 2024
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (21)