Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria for Screening

Male or female at the age of 20 to 75 years
Voluntary written informed consent to participation in this study
Patients with hypertension either newly diagnosed or without treatment of antihypertensive drugs within 4 weeks of screening, who have mean seated diastolic blood pressure (msDBP) ≥ 100 mmHg at screening, or
Patients who have been on a stable dose of antihypertensive drugs for at least 4 weeks before run-in period and meet the following blood pressure criteria at screening: Monotherapy: msDBP ≥ 95 mmHg, or Dual combination therapy: msDBP ≥ 90 mmHg, or Triple combination therapy: 70 mmHg ≤ msDBP < 90 mmHg

Inclusion criteria for randomization

msSBP/DBP at randomization: msSBP ≥ 140 mmHg (msSBP ≥ 130 mmHg in subjects with diabetes or chronic renal disease), and msDBP ≥ 90 mmHg (msDBP ≥ 80 mmHg in subjects with diabetes or chronic renal disease)

Exclusion Criteria:

msDBP ≥ 115mmHg or msSBP ≥ 200 mmHg measured at screening and randomization
Patients with mini-max blood pressure difference of SeSBP ≥ 20 mmHg or SeDBP ≥ 10 mmHg in the chosen arm at screening
Patients with blood pressure difference of SeSBP ≥ 20 mmHg and SeDBP ≥ 10 mmHg in both arms at screening
Patients with hypersensitivity to the investigational product or any of its components
Patients with medical history or hypersensitivity to sulfonamide, dihydropyridine, or thiazide diuretics
History of secondary hypertension or history of any of the diseases suspected of secondary hypertension
Symptomatic orthostatic hypotension
Uncontrolled diabetes mellitus
Severe heart disease, or ischemic heart disease, peripheral vascular disease
Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter, or other arrhythmia considered clinically significant
Hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, or hemodynamically significant stenosis on aortic valve or mitral valve.
Severe cerebrovascular disorder
Known moderate or malignant retinopathy
Consumption disease , autoimmune disease, or connective tissue disease
Patients requiring chronic anti-inflammatory treatment
Anuria or severe renal failure
Severe hepatic failure, AST or ALT > 3 times the upper limit of normal, biliary obstruction, biliary cirrhosis, or cholestasis
Patients who have been treated for hyponatremia, hypokalemia, hyperkalemia, hypercalcemia, or symptomatic hyperuricemia
Addison's disease
Glucose-galactose malabsorption, galactose intolerance, or Lapp lactase deficiency
Gastrointestinal tract disease or surgical operation that may affect absorption, distribution, metabolism, and excretion of drugs, presence of active gastritis or gastrointestinal/rectal bleeding considered clinical significant by the investigator, active inflammatory bowel syndrome within the last 12 months, etc
Patients with history of or suspected of drug or alcohol abuse
Pregnant or lactating women, or women of childbearing potential who do not agree to use appropriate contraceptive methods such as progestin hormone therapy (Oral, implant), intrauterine device, barrier methods of contraception (condom or occlusive cap (diaphragm or cervical/vault caps) with spermicide), male sterilisation or true abstinence
Patients who participated in other clinical study within 1 month prior to screening
Patients considered to be incapable of complying with the protocol