A Randomized, Double-blind, Candesartan-controlled, Parallel Group Comparison Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan in Patients With Mild to Moderate Essential Hypertension (Phase IIIb)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 290
- 试验地点
- 1
- 主要终点
- Sitting Diastolic Blood Pressure
研究概览
简要总结
The purpose of this clinical study is to evaluate and compare the efficacy and safety of Fimasartan (60mg / 120mg) with Candesartan(8mg) in patients with mild to moderate hypertension.
详细描述
A randomized, double-blind, Candesartan controlled, parallel group comparison clinical study to evaluate the antihypertensive efficacy and safety of Fimasartan in patients with mild to moderate hypertension Approximately 288 patients will be enrolled in 10 centers in South Korea. This study has planned 5 visits during 14 weeks (placebo run-in period 2 weeks, treatment period 12 weeks). All of the subjects who agreed to participate in this study and gave the written informed consent voluntary are assessed the exclusion and inclusion criteria and receive the investigational product(placebo) at screening visit.
During more than 14 days of placebo run-in period, subjects have to stop the previous anti-hypertension drug. After 2 weeks, subjects are assessed the final eligibility and randomized into one of 3 groups(Fimasartan 60mg, Fimasartan 120mg, Candesartan 8mg) at baseline visit. Subjects take physical and laboratory tests and receive the investigational products per 4weeks during treatment period (12weeks).
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 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 19 to 75 years
- •Mild to moderate essential hypertension subjects who are measured more 90mmHg, less than 110mmHg 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 110mmHg of SiDBP and/or more 180 mmHg of Sitting systolic blood pressure (SiSBP)
- •Patients with secondary hypertension
- •Patients with significant investigations - abnormal renal function (Creatinine more than upper limit of normal), abnormal liver function (AST, ALT more 2 times than upper normal), moderate fatty lever needed medication
- •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
- •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
研究组 & 干预措施
Fimasartan 60mg
Take one tablet of Fimasartan 60mg once a day in the morning
干预措施: Fimasartan 60mg (Drug)
Fimasartan 120mg
Take one tablet of Fimasartan 120mg once a day in the morning
干预措施: Fimasartan 120mg (Drug)
Candesartan 8mg
Take one tablet of Candesartan 8mg once a day in the morning
干预措施: Candesartan cilexetil (Drug)
结局指标
主要结局
Sitting Diastolic Blood Pressure
时间窗: 12weeks from baseline visit
To compare the difference of Sitting Diastolic Blood Pressure at 12 weeks from baseline visit Fimasartan 60mg with Candesartna 8mg
次要结局
- Sitting DBP(at 12weeks from Baseline visit)
- SittingDBP(at 4, 8 weeks from baseline visit)
- Sitting Systolic Blood Pressure(at 4,8,12 weeks from baseline visit)
- Responder ratio(at 12weeks from baseline visit)