A Randomized, Double-Blind, Placebo-Controlled, 3x3 Factorial Design, Phase II Study to Evaluate the Antihypertensive Efficacy and Safety of Combination of Fimasartan and Amlodipine in Patients With Essential Hypertension

Inclusion criteria

• Subjects who agreed to participate in this study and submitted the written informed consent
• Subjects aged 20 to 75 years
• Essential hypertension subjects who are measured more 90mmHg, less than 114mmHg of sitting diastolic blood pressure (SiDBP) at baseline(day 0).
• Subjects who considered to understand this study , be cooperative, and able to be followed-up whole of the study period.

Exclusion criteria

• Severe hypertension patients; more 115mmHg of SiDBP and/or more 185 mmHg of Sitting systolic blood pressure (SiSBP)
• Patients with secondary hypertension
• Patients with significant investigations - abnormal renal function (Creatinine more 1.5 times than upper limit of normal), abnormal liver function (AST, ALT more 2 times than upper normal), moderate fatty lever needed medication
• Patients with significant investigations - Hypokalemia(Less than 3.5mmol/L), Hyperkalemia(exceeded 5.5mmol/L)
• Patients with sodium ion or body fluid is depleted and not able to correct
• Patients with hypotension who has sign and symptom
• Patients with surgical and medical disease it is able to be affect to absorption, distribution, metabolism, excretion
• Patients with severe insulin dependent or uncontrolled diabetes mellitus (HbA1c > 9%, regimen change of oral hypoglycemic agent, using insulin)
• Patients with severe heart disease, ischemic heart disease within 6months, peripheral vascular disease, Percutaneous Transluminal Coronary Angiography (PTCA), Coronary Artery Bypass Graft (CABG)
• Patients with significant ventricular tachycardia, atrial fibrillation, atrial flutter or other significant arrhythmia
• Patients with hypertrophic obstructive cardiomyopathy, severe obstructive coronary artery disease, aortic stenosis, hemodynamically significant aortic valve or mitral valve disease
• Patients with severe cerebrovascular disease
• Patients with wasting disease, autoimmune disease, connective tissue disease at present and/or previous.
• Patients with known severe or malignancy retinopathy
• Patients with hepatitis B or C or HIV positive reaction
• Patients who have a story or evidence of alcohol or drug abuse within 2years
• Patients who are measured the mean difference of mean blood pressure of both arm under SiDBP 10mmHg or SiSBP 20mmHg at screening and baseline visit
• Patients with history of allergic reaction to any angiotensin II antagonist
• Patients with any chronic inflammation disease needed to chronic inflammation therapy
• Patients with the medical histories of malignant tumor within 5years, except local basal cell carcinoma of the skin
• Childbearing and breast-feeding women
• Female who plan to become pregnancy or have a possibility of pregnancy but don't prevent conception with acknowledged methods
• Patients who took medicine within 12 weeks from screening visit or is going on the progress of other clinical trial
• Subject who are judged unsuitable to participate in this study by investigator