A Randomized, Double-blind, Losartan-controlled, Parallel Group Comparison Dose Titration Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan 60mg~120mg 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
- 506
- 主要终点
- Diastolic Blood Pressure Change
研究概览
简要总结
The purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan (BR-A-657•K) 60 mg~120 mg in patients with mild to moderate essential hypertension.
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, Losartan-controlled, Parallel Group Comparison Dose Titration Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan (BR-A-657•K) 60mg~120mg in Patients with Mild to Moderate Essential Hypertension.
Approximately 480 patients will be enrolled over 12 months in 24 centers nationwide.
After 2 weeks of placebo run-in period, all subjects will be randomized into one of the following 2 groups. Subjects will take test/control drug for 12 weeks of treatment period. And Extensin study have 12 weeks in treatment period.
If subjects take any antihypertensive medications before screening, the subjects will have 1 week of wash-out period.
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 Placebo visit and Baseline are 90~109mmHg inclusive and the difference between sitting diastolic blood pressures measured at Placebo visit and Baseline(Day0) 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 89mmHg or more than 110mmHg 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 12weeks, 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(include carrier)
- •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 participated other clinical trial 12 weeks before Screening Patients judged to be inappropriate for this study by the investigator with other reasons
研究组 & 干预措施
2
Losartan group
干预措施: Losartan (Control) (Drug)
1
Fimasartan 60mg, 120mg
干预措施: Fimasartan (Drug)
结局指标
主要结局
Diastolic Blood Pressure Change
时间窗: baseline and 12 weeks
Value of DBP at 12 Weeks minus value of DBP at Baseline while in a sitting position
次要结局
- Diastolic Blood Pressure Change(baseline and 4 weeks, 8 weeks)