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

Boryung Pharmaceutical Co., Ltd1 个研究点分布在 1 个国家目标入组 420 人开始时间: 2011年8月最近更新: 2016年7月1日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Boryung Pharmaceutical Co., Ltd
入组人数: 420
试验地点: 1
主要终点: Sitting Diastolic Blood Pressure

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan

研究设计

研究类型: Interventional
分配方式: Randomized
干预模型: Factorial
主要目的: Treatment
盲法: Double (Participant, Investigator)

入排标准

年龄范围: 20 Years 至 75 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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.

排除标准

•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