| Eligibility |
Inclusion Criteria:
1. Men and women between the ages of 19 and 75
2. Those whose blood pressure measured at the time of screening meets the following
criteria 2.1 Not taking antihypertensive drugs (Naïve): 140 mmHg = MSSBP (mean sitting
SBP) < 180 mmHg 2.2 If you are taking antihypertensive drugs or have diabetes or
chronic kidney disease: 130 mmHg = MSSBP < 180 mmHg
3. Those whose blood pressure measured at the time of randomization meets the following
criteria 3.1. 140 mmHg = MSSBP < 180 mmHg 3.2. Or patients with diabetes or chronic
kidney disease 130 mmHg = MSSBP < 180 mmHg (However, patients with chronic kidney
disease who have clinically significant albuminuria or proteinuria within 6 months)
4. Those who voluntarily agreed to participate in this clinical trial and signed the
consent form
Exclusion Criteria:
1. Those whose blood pressure measured at screening and randomization is MSDBP (Mean
Sitting DBP) = 110 mmHg
2. Patients who showed a difference of SBP 20 mmHg or more and DBP 10 mmHg or more in
blood pressure measured 3 times in both arms at screening
3. Patients with a history of secondary hypertension or any history of suspected
secondary hypertension (aortic stenosis, primary hyperaldosteronemia, renal artery
stenosis, Cushing's disease, pheochromocytoma, polycystic kidney disease, etc.)
4. Patients with symptomatic orthostatic hypotension
5. Patients requiring concomitant administration of other antihypertensive drugs in
addition to investigational drugs during clinical trial participation (Diuretics,
ß-blockers, ACE inhibitors, Angiotensin II Receptor Blocker, Calcium Channel Blockers,
a-blockers, Renin Inhibitors, Vasodilators, etc.)
6. Patients with the following past medical history/comorbidities at the screening visit
6.1. Uncontrolled diabetic patients with HbA1c = 9% 6.2. Patients with severe heart
disease (heart failure (NYHA class 3 and 4)), ischemic heart disease (unstable angina,
acute myocardial infarction) within 6 months of screening, peripheral vascular
disease, percutaneous coronary angioplasty or coronary artery bypass surgery ruler)
6.3. Patients with clinically significant ventricular tachycardia, atrial
fibrillation, atrial flutter, or other arrhythmias determined by the investigator to
be clinically significant 6.4. Patients with hypertrophic obstructive cardiomyopathy,
severe obstructive coronary artery disease, hemodynamically significant aortic
stenosis, stenosis on the aortic or mitral valve 6.5. Patients with the severe
cerebrovascular disorder (stroke, cerebral infarction, cerebral hemorrhage, etc.
within 6 months of screening) 6.6. Patients with known moderate or malignant
retinopathy (retinal hemorrhage within 6 months of screening, visual impairment,
retinal microaneurysm) 6.7. Patients with wasting disease, autoimmune disease,
connective tissue disease 6.8. Patients with gastrointestinal diseases and surgeries
that may affect drug absorption, distribution, metabolism, and excretion, current
active gastritis, gastrointestinal/rectal bleeding, gastric ulcer, pancreatic
dysfunction such as pancreatitis, active inflammatory bowel syndrome within 12 months
of screening Back (However, simple appendectomy and hernia surgery are excluded) 6.9.
Patients with hereditary angioedema or with a history of angioedema when treated with
ACE inhibitors, renin inhibitors, or angiotensin II receptor antagonists 6.10.
cholestatic disease patient 6.11. shock patient 6.12. Patients with anuria 6.13.
Patients with symptomatic hyperuricemia (history of gout or uric acid stones) 6.14.
Patients with a history of malignant tumors including leukemia and lymphoma within 5
years of screening (however, those who have been evaluated as having complete response
after treatment and have not relapsed within 2 years of screening, or malignant tumors
that have occurred are the only Those with basal cell carcinoma or squamous cell
carcinoma of the skin can participate in this test) 6.15. Patients with any chronic
inflammatory condition requiring chronic anti-inflammatory treatment
7. Persons whose laboratory test results at the screening visit fall under the following
7.1. Those whose ALT or AST levels are more than 3 times the upper limit of normal
organ 7.2. Those whose serum creatinine level is 1.5 times or more of the upper limit
of normal organ 7.3. Patients with renal impairment with severe renal failure with
Creatinine Clearance (CrCl) < 30 mL/min or eGFR < 30 ml/min/1.73 m2 7.4. Hypokalemia
(Serum K < 3.5 mmol/L) 7.5. Persons with hyperkalemia (Serum K > 5.5 mmol/L) 7.6.
Those with hyponatremia (Serum Na < 135.0 mmol/L) 7.7. Those with hypercalcemia (Serum
Ca > 2.75 mmol/L or 11 mg/dL)
8. Those with genetic problems such as galactose intolerance, Lapp lactase deficiency, or
glucose-galactose malabsorption
9. Persons with or suspected of drug or alcohol abuse
10. Pregnant or lactating women
11. Women and men of childbearing potential who do not agree to use a combination of
effective or medically acceptable contraceptive methods* for the duration of the
clinical trial and 4 weeks after administration of the last investigational drug
* Taking birth control pills or implanting hormones, implanting intrauterine devices
or intrauterine systems, double-blocking methods (both male (condom) and female
(contraceptive diaphragm, vaginal sponge or cervical cap) using a contraceptive
device), sterilization ( vasectomy, tubal ligation, etc.)
12. Persons with a history of hypersensitivity to clinical investigational drug components
and other dihydropyridine drugs, thiazide drugs, or sulfonamide derivatives
13. Those who participated in another clinical trial within 4 weeks before the screening
visit and received the investigational drug
14. Others who are judged to be unable to participate in clinical trials cording to the
judgment of the investigator
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