A Randomized, Double-Blind, Placebo-Controlled, Parallel Grouped, Clinical Study to Evaluate the Antihypertensive Efficacy and Tolerability and to Determine the Adequate Antihypertensive Dosage of Fimasartan(BR-A-657-K) in Patients With Mild to Moderate Essential Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 182
- 试验地点
- 1
- 主要终点
- change from baseline to end of 8 week treatment in sitting diastolic blood pressure
研究概览
简要总结
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.
详细描述
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,
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Placebo
3 tablets of placebo will be taken 30minutes after breakfast for 8 weeks
干预措施: Fimasartan (Drug)
Fimasartan 20mg
2 tablets of placebo and 1 tablets of fimasartan 20mg will be taken 30minutes after breakfast for 8 weeks
干预措施: Fimasartan (Drug)
Fimasartan 60mg
3 tablets of fimasartan 20mg will be taken 30minutes after breakfast for 8 weeks
干预措施: Fimasartan (Drug)
Fimasartan 120mg
3 tablets of fimasartan 40mg will be taken 30minutes after breakfast
干预措施: Fimasartan (Drug)
Fimasartan 240mg
3 tablets of fimasartan 80mg will be taken 30minutes after breakfast for 8 weeks
干预措施: Fimasartan (Drug)
结局指标
主要结局
change from baseline to end of 8 week treatment in sitting diastolic blood pressure
时间窗: 8 week from baseline
次要结局
- change from baseline to end of 2,4 week treatment in sitting diastolic blood pressure(2, 4 week from baseline)
- change from baseline to end of 2,4,8 week treatment in sitting systolic blood pressure(2,4,8 week from baseline)
- responders after end of 8 week treatment(portion of DBP<90mmHg or the difference from baseline and end of 8 week treatment>10mmHg(8 week from baseline)