A Randomized, Double-Blind, Multicenter, Phase 3 Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan(BR-A-657∙K) 30mg Compared to Placebo in Patients With Mild to Moderate Essential Hypertension
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 293
- 试验地点
- 1
- 主要终点
- the difference of sitting DBP
研究概览
简要总结
A Randomized, Double-Blind, Multicenter, phase III Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan (BR-A-657·K) 30mg Compared to Placebo in Patients with Mild to Moderate Essential Hypertension
详细描述
After subjects have signed informed consent voluntarily, when they are taking hypertension medication, they go through screening period for 7 days including wash-out period.
After screening and wash-out period, subjects take the placebo for 14 days (Maximum 21 days), and evaluate their suitability to Inclusion and Exclusion criteria.
Patients, who evaluated the proper subject for this clinical trial, are allocated to experimental group (Fimasartan 30mg) or Control group (Placebo group) or Reference group (Valsartan 80mg) randomly at a ratio 2:2:1 and their investigational drugs will be administered daily for the study period (8 weeks). Subjects visit their investigators twice during treatment period, when they take their investigational drugs for 4 weeks, and 8 weeks.
The placebo period will be single-blinded and the treatment allocation in this study will be double-blinded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 clinical trial and submitted the written informed consent
- •Subjects aged 20 to 75 years
- •Essential hypertension patients who are measured more 90mmHg, less than 110mmHg of sitting diastolic blood pressure(SiDBP) at baseline(Day 0)
- •Subject who considered to understand this clinical trial, be cooperative,and able to be followed-up whole of the clinical trial period
排除标准
- •Severe hypertension patients: more 110mmHg of mean SiDBP and/or more 185mmHg of mean Sitting systolic blood pressure(SiSBP)
- •Patients with orthostatic hypotension who has sign and symptom
- •Patients with secondary hypertension
- •Patients who are measured the difference of mean blood pressure of one arm under SiDBP 10mmHg or SiSBP 20mmHg at screening and baseline visit
- •Patients who cannot stop administration of hypertension medication through the clinical trial period, and can take any other hypertension medication except investigational drugs
- •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 limit of normal), severe fatty liver disease needed medication
- •Patients with clinically significant investigations in laboratory test of screening visit
- •Patients with surgical and medical disease that is able to be affect to absorption, distribution, metabolism and 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 6 months, 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 with the medical histories of malignant tumor within 5 years,except local basal cell carcinoma of the skin
- •Patients who have a story or evidence of alcohol or drug abuse within 2 years
- •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
- •Patients with significant investigations-Hypokalemia(Less than 3.5 mmol/L), Hyperkalemia(exceeded 5.5 mmol/L)
- •Patients with sodium ion or body fluid is deplated and not able to correct
- •Subject who are judged unsuitable to participate in this clinical trial by investigator
研究组 & 干预措施
Placebo
1 capsule/day of placebo will be orally administered for the study period (8 weeks)
干预措施: Placebo (Drug)
Valsartan 80mg
(As reference group) 80mg/day of Valsartan will be orally administered for the study period (8 weeks)
干预措施: Valsartan (Drug)
Fimasartan 30mg
30mg/day of Fimasartan will be orally administered for the study period (8 weeks)
干预措施: Fimasartan (Drug)
结局指标
主要结局
the difference of sitting DBP
时间窗: After 8 weeks from baseline visit
To compare the difference of sitting DBP between fimasartan 30mg group and placebo group
次要结局
- the difference of sitting DBP(After 8 weeks from baseline visit)
- the difference of SiDBP(After 4 weeks from baseline visit)
- the difference of SiSBP(After 4 weeks and 8 weeks from baseline visit)
- the ratio of responder(SiDBP<90mmHg or ΔSiDBP≥10mmHg)(After 8 weeks from baseline visit)
- the ratio of subjects who get normalized blood pressure(SiDBP<90mmHg & SiSBP<140mmHg)(After 8 weeks from baseline visit)