Efficacy and Safety of TAH Combination in Comparison With Telmisartan/Amlodipine Combination for Essential Hypertension Patients

Inclusion criteria

• 19 years old or above Koreans living in Korea
• Patients with uncontrolled essential hypertension at screening time(Visit 1)

• Naïve: 160 mmHg ≤ sitSBP < 200 mmHg
• Use antihypertensive drugs:140 mmHg ≤ sitSBP < 200 mmHg
• Patients with uncontrolled hypertension after Telmisartan/Amlodipine 40/5mg treatment for 6 weeks at randomization(Visit 2)

• 140 mmHg ≤ sitSBP < 200 mmHg
• Patients who agreed to participate in the trial

Exclusion criteria

• Test results showing the following values at screening time(Visit 1)

• The change of mean sitSBP ≥ 20 mmHg or sitDBP ≥ 10 mmHg on target arm between 1st and 2nd measurement
• screening time(Visit 1), time of randomization(Visit 2): sitDBP ≥ 120 mmHg
• Patients with secondary blood pressure or suspected of secondary blood pressure (for example,aortic coarctation, primary aldosteronism, renal artery stenosis, pheochromocytoma)
• -Patients with congestive heart failure(NYHA class III~IV)

• Patients with unstable angina or myocardial infarction or valvular heart disease within 6 months prior to study entry
• Patients who have severe ventricular tachycardia, atrial fibrillation, atrial flutter or clinically significant arrhythmia
• Patients who have history of cerebrovascular disease as cerebral infarction, cerebral hemorrhage within 6 months prior to study entry
• Type I Diabets Mellitus or Type II Diabetes Mellitus with HbA1c > 9%
• Patients who have history of severe or malignant retinopathy within 6 months prior to study entry
• Patients who suspected of Renal dysfunction that may affect the absorption, distribution, metabolism or excretion (Serum Creatinine :> 2mg/dL ), gastrointestinal, haematological, liver disease (AST or ALT > 2.5 times of upper limit of normal range)
• Patients who should be administered antihypertensive drugs other than clinical trial medication(Diuretics, β-blockers, ACE inhibitors, Angiotensin II Receptor Blocker, Calcium Channel Blockers, α-blockers, Renin Inhibitors, Vasodilators)
• Patients who should be administered medications prohibited for concomitant use during study period
• Patients who are dependent on drugs or alcohol
• Patients with surgical and medical disease that may affect the absorption, distribution, metabolism or excretion
• Patients with hypersensitivity to the components of investigational drug.
• Patients with hypersensitivity to Sulfonamide
• Patients with anuria
• Patients with hypercalcemia, hyponatremia/hypokalemia
• Patients with Addison's disease
• Patients who have hereditary problems such as galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption
• Patients with any chronic or accute inflammation disease needed to chronic inflammation therapy
• History of malignant tumor including leukemia, lymphoma within 5 years
• Patients taking other clinical trial drugs within 30 days from the time of visit for screening
• Pregnancy, breast-feeding, or child-bearing potential Patients
• Patients who are judged unsuitable to participate in this study by investigator