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The purpose of this study is to evaluate the efficacy and safety of OLOMAX Tab (20/5/5mg, 20/5/10mg) in Hypertension Patients with Low-Intermediate Risk for Cardiovascular Disease.
The patients who meet the inclusion/exclusion criteria will be randomized 1:1:1 to test group 1 (olomax tablet 20/5/5mg), test group 2 (olomax tablet 20/5/10mg), and control group (sevica tablet 5/20mg.
After randomization, the drug will be administered for 8 weeks according to the assigned group.
During the administration period, subjects will conduct a total of three outpatient visits at 4 weeks (Visit 3) and 8 weeks (Visit 4, EOS), including randomized visits (Visit 2).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment 1 | Experimental | OLOMAX 20/5/5mg |
|
| Treatment 2 | Experimental | OLOMAX 20/5/10mg |
|
| Treatment 3 | Active Comparator | Olmesartan 20 mg/Amlodipine 5 mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| OLOMAX 20/5/5mg | Drug | Tablets, Oral, QD |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| mLDL-C change rate (%) | mLDL-C change rate (%) at 8 weeks after administration compared to baseline in test group 1 and control group | 8 weeks |
| mLDL-C change rate | mLDL-C change rate (%) at 8 weeks after administration compared to baseline in test group 2 and control group | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change rate (%) in mLDL-C | Change rate (%) in mLDL-C at 4 weeks of administration of investigational drug compared to baseline | 4 weeks |
| cLDL-C* change rate | cLDL-C* change rate (%) at 4 weeks of administration of investigational drug compared to baseline |
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Inclusion Criteria:
Screening (Visit 1) Inclusion Criteria
Men and women over 19 years of age as of the date of written consent
High blood pressure patients who meet the following criteria - In case of new arrivals, Sitting systolic blood pressure (sitSBP) ≥ 160 mmHg or sitting diastolic blood pressure (sitDBP) ≥ 100 mmHg, or
Those who meet the following mLDL-C criteria* (*Korean Society of Lipid and Atherosclerosis Dyslipidemia Treatment Guideline 3)
- For cardiovascular disease low risk group #1, LDL-C ≥ 130 mg/dL or
For intermediate risk group #2 for cardiovascular disease, LDL-C ≥ 100 mg/dL. #1: Low-risk group: Those who do not have the following major cardiovascular risk factors other than high blood pressure
#2: Moderate risk group: People with one or more of the following major cardiovascular risk factors other than hypertension
Age (men ≥45 years, women ≥55 years)
Family history of early onset coronary artery disease (coronary artery disease occurs in family members [parents, siblings] <55 years old for men and <65 years old for women)
Smoking
High density lipoprotein-cholesterol (HDL-C) <40 mg/dL (However, in case of HDL-C ≥60 mg/dL, 1 is subtracted from the number of major risk factors.)
Those who voluntarily agree to participate in clinical trials and sign a written consent form
Random allocation (visit 2) Inclusion criteria
Exclusion Criteria:
Patient with hypersensitivity Olmesartan, Amlodipine, Rosuvastatin, dihydropyridine
Who disagreed to perform effective contraception during the clinical trial
Orthostatic hypotension with symptoms
Secondary hypertension and suspected secondary hypertension
Creatinine clearance < 30mL/min
AST(Aspartate Aminotransferase) or ALT(Alanine Aminotransferase) level ≥ 3x ULN (upper limit of normal range)
Patients with hypersensitivity to the main ingredient (Olmesartan, Amlodipine or Rosuvastatin) or components of the investigational drug or dihydropyridine derivatives
Pregnant and lactating women, women and men of childbearing potential who do not agree to use appropriate contraception during the clinical trial period
Patients with symptomatic orthostatic hypotension
Patients with secondary hypertension or patients suspected of having secondary hypertension (e.g. aortic coarctation, hyperaldosteronism, renal artery stenosis, Cushing's syndrome, pheochromocytoma, polycystic kidney disease, etc.)
Those with confirmed medical history, concomitant diseases, or surgical history/procedure history:
â‘ The following cardiovascular disease occurred within 24 weeks from the time of screening
Coronary artery disease, atherosclerotic ischemic stroke and transient cerebral ischemic attack, peripheral artery disease, carotid artery disease (limited to cases where significant carotid artery stenosis is confirmed), abdominal aneurysm, severe aortic stenosis, coronary artery revascularization (PTCA or CABG) , Arrhythmias requiring treatment (ventricular tachycardia, etc.)
Myopathy, including rhabdomyolysis, that occurred within 24 weeks from the time of screening
â‘¢ Biliary obstruction occurring within 24 weeks from the time of screening
Triglyceride (TG) ≥ 500 mg/dL ③ Active liver disease including persistent ALT elevation of unknown cause or AST ≥ 3 ④ The following renal function abnormalities:
Kidney dialysis or
Patients with severe renal impairment (creatinine clearance (CLcr) < 30 mL/min)
Hyperkalemia (K >5.5 mEq/L)
Hyponatremia (Na <135 mEq/L) or uncorrected sodium depletion ⑦ Hyperuricemia (Uric acid >10 mg/dL) 7) Those who have taken statin drugs or non-statin lipid regulators within 8 weeks before screening 8) Those expected to be administered the following drugs during the clinical trial period, including screening
Antihypertensive drugs other than clinical investigational drugs â‘¥ Other drugs that may affect blood lipids 9) People with genetic problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption 10) A person who has received another investigational drug or a clinical trial medical device within 30 days before screening 11) Other people deemed unsuitable for participation in clinical trials according to the judgment of the investigator
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| Name | Affiliation | Role |
|---|---|---|
| Inho Chae | Seoul National University Bundang Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Daewoong pharmatceutical | Seoul | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37814541 | Derived | Kim BJ, Cha KS, Cho WH, Kim EJ, Choi SH, Kim MH, Kim SH, Park JB, Park SM, Sohn IS, Ryu KH, Chae IH. Efficacy and Safety of a Single-Pill Triple Combination of Olmesartan, Amlodipine, and Rosuvastatin in Hypertensive Patients with Low-to-Moderate Cardiovascular Risk: A Multicenter, Randomized, Open-Label, Active-Control, Phase IV Clinical Trial. J Cardiovasc Pharmacol Ther. 2023 Jan-Dec;28:10742484231205204. doi: 10.1177/10742484231205204. |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D050171 | Dyslipidemias |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C437965 | olmesartan |
| D017311 | Amlodipine |
| ID | Term |
|---|---|
| D004095 | Dihydropyridines |
| D011725 | Pyridines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| OLOMAX 20/5/10mg | Drug | Tablets, Oral, QD |
|
|
| Olmesartan 20 mg/Amlodipine 5 mg | Drug | Tablets, Oral, QD |
|
|
| 4 weeks |
| cLDL-C* change rate | cLDL-C* change rate (%) at 8 weeks of administration of investigational drug compared to baseline | 8 weeks |
| Change amount and rate of change (%) in each of the following lipid indicators | Change amount and rate of change (%) in each of the following lipid indicators at 4 weeks of administration of the investigational drug compared to the baseline | 4 weeks |
| Change amount and rate of change (%) in each of the following lipid indicators | Change amount and rate of change (%) in each of the following lipid indicators at 8 weeks of administration of the investigational drug compared to the baseline | 8 weeks |
| Proportion of test subjects with mLDL-C less than 70 mg/dL | Proportion of test subjects with mLDL-C less than 70 mg/dL at 4 weeks of administration of investigational drug (%) | 4 weeks |
| Proportion of test subjects with mLDL-C less than 70 mg/dL | Proportion of test subjects with mLDL-C less than 70 mg/dL at 8 weeks of administration of investigational drug (%) | 8 weeks |
| Proportion of test subjects with mLDL-C less than 100 mg/dL | Proportion of test subjects with mLDL-C less than 100 mg/dL at 4 weeks of administration of investigational drug (%) | 4 weeks |
| Proportion of test subjects with mLDL-C less than 100 mg/dL | Proportion of test subjects with mLDL-C less than 100 mg/dL at 8 weeks of administration of investigational drug (%) | 8 weeks |
| Change and rate of change in sitSBP (%) | Change and rate of change in sitSBP (%) at 4 weeks of administration of investigational drug compared to baseline | 4 weeks |
| Change and rate of change in sitDBP (%) | Change and rate of change in sitDBP (%) at 8 weeks of administration of investigational drug compared to baseline | 8 weeks |
| Blood pressure normalization* rate (% | Blood pressure normalization* rate (%) at 8 weeks after administration of investigational drug | 8 weeks |
| Change amount and rate of change (%) | Change amount and rate of change (%) in each of the following sugar indicators at 4 weeks of administration of the investigational drug compared to the baseline | 4 weeks |
| Change amount and rate of change (%) | Change amount and rate of change (%) in each of the following sugar indicators at 8 weeks of administration of the investigational drug compared to the baseline | 8 weeks |
| D009750 | Nutritional and Metabolic Diseases |