Efficacy and Safety of Ezetimibe/Rosuvastatin and Amlodipine Patients With High Blood Pressure and High Cholesterol
2026년 5월 5일 업데이트: Celltrion Pharm, Inc.
A Multi-center, Randomized, Double-blind, Active-controlled, Phase III Trial to Evaluate the Efficacy and Safety of Ezetimibe/Rosuvastatin and Amlodipine Combination Therapy in Essential Hypertension Patients With Primary Hypercholesterolemia
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.
연구 개요
상태
완전한
상세 설명
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).
연구 유형
중재적
등록 (실제)
163
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
-
Ansan, 대한민국
- Korea University Ansan Hospital
-
Anyang, 대한민국
- Hallym University Sacred Heart Hospital
-
Busan, 대한민국
- Kosin University Gospel Hospital
-
Busan, 대한민국
- Pusan National University Hospital
-
Cheonan, 대한민국
- Dankook University Hospital
-
Daegu, 대한민국
- Keimyung University Dongsan Medical Center
-
Daegu, 대한민국
- Yeungnam University Hospital
-
Daegu, 대한민국
- Daegu Catholic University Medical Center
-
Gwangju, 대한민국
- Chonnam National University Hospital
-
Incheon, 대한민국
- Gachon University Gil Medical Center
-
Jeonju, 대한민국
- Jeonbuk National University Hospital
-
Seongnam, 대한민국
- CHA University Bundang Medical Center
-
Seoul, 대한민국
- Asan Medical Center
-
Seoul, 대한민국
- Kangbuk Samsung Hospital
-
Seoul, 대한민국
- Korea University Anam Hospital
-
Seoul, 대한민국
- Korea University Guro Hospital
-
Seoul, 대한민국
- Severance Hospital
-
Seoul, 대한민국
- The Catholic University of Korea Seoul St. Mary's Hospital
-
Seoul, 대한민국
- Nowon Eulji Medical Center, Eulji University
-
Uijeongbu-si, 대한민국
- Uijeongbu Eulji Medical Center, Eulji University
-
Uijeongbu-si, 대한민국
- The Catholic University of Korea Uijeongbu St. Mary's Hospital
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Screening Inclusion Criteria:
- 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
Randomization Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- Patients with gastrointestinal disease or a history of surgery that may affect drug absorption, distribution, metabolism, or excretion, including current active gastritis, gastrointestinal or rectal bleeding, a history of major gastrointestinal surgery, a history of active inflammatory bowel disease within 12 months before screening, or hereditary disorders such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.
- History of drug or alcohol abuse
- Pregnant or breastfeeding participants, or participants unwilling to use appropriate contraception during the study period
- History of malignancy within 5 years before screening, except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, thyroid cancer, or carcinoma in situ of other sites, provided that the disease was successfully treated and there has been no recurrence for at least 3 years; enrollment may be considered at the investigator's medical discretion.
- Use of another investigational product within 4 weeks prior to screening
- Any other condition or circumstance that, in the investigator's judgment, would make the participant unsuitable for study participation
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Amlodipine, Ezetimibe/Rosuvastatin
|
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.
|
|
활성 비교기: Amlodipine, Ezetimibe/Rosuvastatin placebo
|
Oral tablet containing amlodipine 10 mg administered for 8 weeks.
Placebo for ezetimibe/rosuvastatin (10mg/20mg)
|
|
활성 비교기: Amlodipine placebo, Ezetimibe/Rosuvastatin
|
Fixed-dose combination oral tablet containing ezetimibe 10 mg and rosuvastatin 20 mg administered for 8 weeks.
Placebo for amlodipine (10mg)
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8 in Treatment Group and Control Group 1
기간: Baseline, Week 8
|
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
기간: Baseline, Week 8
|
Change from baseline in mean sitting systolic blood pressure.
Change is calculated as the Week 8 value minus the baseline value.
|
Baseline, Week 8
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 4 in the Treatment Group and Control Group 1
기간: Baseline, Week 4
|
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
기간: 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
기간: Baseline, Week 4, Week 8
|
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
기간: 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
기간: Baseline, Week 4, Week 8
|
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.
|
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
기간: 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.
|
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
기간: Week 4, Week 8
|
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.
|
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
기간: Week 4, Week 8
|
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.
|
Week 4, Week 8
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2022년 8월 5일
기본 완료 (실제)
2024년 2월 13일
연구 완료 (실제)
2024년 2월 13일
연구 등록 날짜
최초 제출
2026년 4월 27일
QC 기준을 충족하는 최초 제출
2026년 4월 27일
처음 게시됨 (실제)
2026년 5월 4일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 8일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 5일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- CTP-EAR 3.1
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
IPD 계획 설명
This completed study is being registered retrospectively, and no prospective plan for IPD sharing was specified in the original protocol.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .