antihypertensive efficacy and tolerability and determine the adequate antihypertensive dosage of fimasartan in mild to moderate essential hypertension patients

Conditions: Hypertension

Summary: the purpose of this study is to evaluate the antihypertensive efficacy and tolerability of 8 week treatment with fimasartan (br-a-657-k) 20, 60, 120, 240 mg and placebo in patients with mild to moderate essential hypertension and to determine the adequate antihypertensive dosage for later clinical study.

fimasartan (br-a-657-k), a selective blocker of at1 receptor subtype, showed the rapid and potent antihypertensive effect in many hypertensive models. phase i study, fimasartan (br-a-657-k) 20mg \~ 480mg single dosing with healthy subjects, demonstrated that the fimasartan (br-a-657-k) was very safe and well tolerated. another phase i study, fimasartan (br-a-657-k) 120mg and 360mg dosing for 7 days, also showed that fimasartan (br-a-657-k) was safe and tolerable though one temporal adverse event was observed in high dose. a randomized, double-blind, placebo-controlled, parallel grouped, clinical study will be conducted to evaluate the antihypertensive efficacy and tolerability and to determine adequate antihypertensive dosage of fimasartan(br-a-657-k) in patients with mild to moderate essential hypertension. approximately 182 patients will be enrolled over 12 months in 8 centers nationwide. after 2 weeks of placebo run-in period, all subjects will be randomized into one of the following 5 groups. subjects will take test/control drug for 8 weeks of treatment period. if subjects take any antihypertensive medications before screening, the subjects will have 1 week of wash-out period. group i : placebo, group ii : fimasartan 20 mg, group iii: fimasartan 60 mg, group iv : fimasartan 120 mg, group v : fimasartan 240 mg,

Eligibility criteria:
inclusion criteria: * mild to moderate essential hypertension : sitting diastolic blood pressure measured at screening and baseline(day1) are 95\~114 mmhg inclusive and the difference between sitting diastolic blood pressures measured at day -14 and baseline(day1) is under 7mmhg. * subjects who agree to participate in this sudy and give written informed consent * subjects considered to understand the study, be cooperative, and able to be followed-up until the end of the study exclusion criteria: * the sitting dbp is less than 94mmhg or more than 115mmhg or severe hypertensive patient with sitting systolic blood pressure over 200mmhg * patients with secondary hypertension * patients with severe renal(creatinine more 1.5 times than upper limit of normal), gastrointestinal, hematological or hepatic(ast, alt more 2 twice more than upper limit of normal)disease etc. which might affect absorption, disposition, metabolism or excretion of the drug * patients with postural hypotension * patients with sever insulin dependent diabetes mellitus or uncontrolled diabetes mellitus(hba1c\>9%, regimen change of oral hypoglycemic agents within 3 months, treated insulin before screening) * patients with a history of myocardial infarction, severe coronary artery disease or clinically significant heart failure or valvular defect in last 6 months * patients with consumptive disease, autoimmune disease, connective tissue disease * patients with a history of type b or c hepatitis * patients with hiv or hepatitis * patients with clinically significant laboratory abnormality * patients receiving any drugs known to affect blood pressure or medical treatments that can influence the blood pressure * patients with allergy or contraindication to any angiotensin ii receptor antagonists * female of childbearing potential who does not undergo hysterectomy or is not post-menopausal * patients judged to have a history of alcohol or drug abuse by the investigator * patients with average weight \> +35% or \<-15% in modified metropolitan life insurance table * patients participated other clinical trial 3 months before screening * patients judged to be inappropriate for this study by the investigator with other reasons

Keywords: hypertension fimasartan