HypertensionPhase 3NCT07564726
Efficacy and Safety of Ezetimibe/Rosuvastatin and Amlodipine Patients With High Blood Pressure and High Cholesterol
A Phase 3 study testing Amlodipine and Ezetimibe/Rosuvastatin in people with Hypertension and Hypercholesterolemia, run by Celltrion Pharm, Inc. at 21 sites in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension, Hypercholesterolemia
- What is being tested?
- Amlodipine and Ezetimibe/Rosuvastatin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 163 participants
- Where
- 21 sitesSouth Korea
- Study dates
- 5 Aug 2022to 13 Feb 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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
Show all 21Show fewer
- 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
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
South Korea21 sites
Korea University Ansan Hospital
Ansan
Hallym University Sacred Heart Hospital
Anyang
Kosin University Gospel Hospital
Busan
Pusan National University Hospital
Busan
Dankook University Hospital
Cheonan
Daegu Catholic University Medical Center
Daegu
Keimyung University Dongsan Medical Center
Daegu
Yeungnam University Hospital
Daegu
Chonnam National University Hospital
Gwangju
Gachon University Gil Medical Center
Incheon
Jeonbuk National University Hospital
Jeonju
Cha University Bundang Medical Center
Seongnam
Asan Medical Center
Seoul
Kangbuk Samsung Hospital
Seoul
Korea University Anam Hospital
Seoul
Korea University Guro Hospital
Seoul
Nowon Eulji Medical Center, Eulji University
Seoul
Severance Hospital
Seoul
The Catholic University of Korea Seoul St. Mary's Hospital
Seoul
The Catholic University of Korea Uijeongbu St. Mary's Hospital
Uijeongbu-si
Uijeongbu Eulji Medical Center, Eulji University
Uijeongbu-si
About this study
Official title: 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.
Read the detailed description
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).
- Conditions
- Hypertension, Hypercholesterolemia
- Being tested
- Amlodipine, Ezetimibe/Rosuvastatin, Ezetimibe/Rosuvastatin Placebo, Amlodipine Placebo
- 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
- Medical subject headings
- Hypertension, Hypercholesterolemia, Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AmlodipineDrug
Oral tablet containing amlodipine 10 mg administered for 8 weeks.
Ezetimibe/RosuvastatinDrug
Fixed-dose combination oral tablet containing ezetimibe 10 mg and rosuvastatin 20 mg administered for 8 weeks.
Ezetimibe/Rosuvastatin PlaceboDrug
Placebo for ezetimibe/rosuvastatin (10mg/20mg)
Amlodipine PlaceboDrug
Placebo for amlodipine (10mg)
| Study group | Role | What they receive |
|---|---|---|
| Amlodipine, Ezetimibe/Rosuvastatin | Experimental | Not described Receives: Drug: Amlodipine; Drug: Ezetimibe/Rosuvastatin |
| Amlodipine, Ezetimibe/Rosuvastatin placebo | Active comparator | Not described Receives: Drug: Amlodipine; Drug: Ezetimibe/Rosuvastatin Placebo |
| Amlodipine placebo, Ezetimibe/Rosuvastatin | Active comparator | Not described Receives: Drug: Ezetimibe/Rosuvastatin; Drug: Amlodipine Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
Percent change from baseline in low-density lipoprotein cholesterol (LDL-C) at Week 4 in the treatment group and control group 1.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 4, Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2026
- Study start5 Aug 2022
- Primary completion13 Feb 2024
- Study completion13 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Celltrion Pharm, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07564726
- Sponsor's protocol ID
- CTP-EAR 3.1
- Status last verified
- May 2026
- First submitted
- 27 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This completed study is being registered retrospectively, and no prospective plan for IPD sharing was specified in the original protocol.
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07564726
- Acronym / sponsor ID
- CTP-EAR 3.1
- Conditions
- Hypertension, Hypercholesterolemia
- Keywords
- low-density lipoprotein cholesterol (LDL-C), mean sitting systolic blood pressure (MSSBP), Amlodipine, Rosuvastatin, Ezetimibe, phase 3, multi-center, randomized
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Celltrion Pharm, Inc.Industry (pharma, biotech, devices)
- Study start
- 5 Aug 2022 (actual)
- Primary completion
- 13 Feb 2024 (actual)
- Study completion
- 13 Feb 2024 (actual)
- First posted
- 4 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Amlodipine, Ezetimibe/Rosuvastatin | Experimental | Drug: Amlodipine, Drug: Ezetimibe/Rosuvastatin |
| Amlodipine, Ezetimibe/Rosuvastatin placebo | Active comparator | Drug: Amlodipine, Drug: Ezetimibe/Rosuvastatin Placebo |
| Amlodipine placebo, Ezetimibe/Rosuvastatin | Active comparator | Drug: Ezetimibe/Rosuvastatin, Drug: Amlodipine Placebo |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AmlodipineOral tablet containing amlodipine 10 mg administered for 8 weeks. | Drug | Amlodipine, Ezetimibe/Rosuvastatin, Amlodipine, Ezetimibe/Rosuvastatin placebo |
| Ezetimibe/RosuvastatinFixed-dose combination oral tablet containing ezetimibe 10 mg and rosuvastatin 20 mg administered for 8 weeks. | Drug | Amlodipine placebo, Ezetimibe/Rosuvastatin, Amlodipine, Ezetimibe/Rosuvastatin |
| Ezetimibe/Rosuvastatin PlaceboPlacebo for ezetimibe/rosuvastatin (10mg/20mg) | Drug | Amlodipine, Ezetimibe/Rosuvastatin placebo |
| Amlodipine PlaceboPlacebo for amlodipine (10mg) | Drug | Amlodipine placebo, Ezetimibe/Rosuvastatin |
Primary outcome
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8 in Treatment Group and Control Group 1
Time frame: Baseline, Week 8
Percent change from baseline in LDL-C level.
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8 in Treatment Group and Control Group 2
Time frame: Baseline, Week 8
Change from baseline in mean sitting systolic blood pressure. Change is calculated as the Week 8 value minus the baseline value.
8 secondary outcomes
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
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
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
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
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
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
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
Time frame: Week 4, Week 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: No. This completed study is being registered retrospectively, and no prospective plan for IPD sharing was specified in the original protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Amlodipine and Ezetimibe/Rosuvastatin in people with Hypertension and Hypercholesterolemia, run by Celltrion Pharm, Inc. at 21 sites in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change From Baseline in Low-Density Lipoprotein Cholesterol (LDL-C) at Week 8 in Treatment Group and Control Group 1 (time frame: Baseline, Week 8). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.