The Clinical Study to Evaluate the Efficacy and Safety of Fimasartan in Patients With Mild to Moderate Essential Hypertension

A randomized, double-blind, Candesartan controlled, parallel group comparison clinical study to evaluate the antihypertensive efficacy and safety of Fimasartan in patients with mild to moderate hypertension Approximately 288 patients will be enrolled in 10 centers in South Korea. This study has planned 5 visits during 14 weeks (placebo run-in period 2 weeks, treatment period 12 weeks). All of the subjects who agreed to participate in this study and gave the written informed consent voluntary are assessed the exclusion and inclusion criteria and receive the investigational product(placebo) at screening visit.

During more than 14 days of placebo run-in period, subjects have to stop the previous anti-hypertension drug. After 2 weeks, subjects are assessed the final eligibility and randomized into one of 3 groups(Fimasartan 60mg, Fimasartan 120mg, Candesartan 8mg) at baseline visit. Subjects take physical and laboratory tests and receive the investigational products per 4weeks during treatment period (12weeks).

Inclusion criteria

• Subjects who agreed to participate in this study and submitted the written informed consent
• Subjects aged 19 to 75 years
• Mild to moderate essential hypertension subjects who are measured more 90mmHg, less than 110mmHg 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 110mmHg of SiDBP and/or more 180 mmHg of Sitting systolic blood pressure (SiSBP)
• Patients with secondary hypertension
• Patients with significant investigations - abnormal renal function (Creatinine more than upper limit of normal), abnormal liver function (AST, ALT more 2 times than upper normal), moderate fatty lever needed medication
• 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
• 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