NCT01878201已完成2 期
A Randomized, Double-blind, Valsartan 80 Mg-Referenced, Parallel Grouped, Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan 30 mg During 24 Hours in Patients With Mild to Moderate Essential Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Mean Systolic Blood Pressure during 24 hours
研究概览
简要总结
The purpose of this study is to Evaluate the Antihypertensive efficacy of Fimasartan 30 mg during 24 hours in Patients with Mild to Moderate Essential Hypertension
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged 20 to 70 years
- •Essential hypertension subjects who are measured more 135/85 mmHg of average Diastolic Blood pressure (DBP) and Systolic Blood pressure (SBP) measured by ABP monitor at baseline visit(day 0)
- •Subjects who agreed to participate in this study and submitted the written informed consent
- •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 180 mmHg of mean sitting SBP and/or more 110 mmHg of mean sitting DBP measured as an office Blood pressure (BP), before Randomization (Screening visit, Placebo run-in visit, Pre-Baseline visit, Baseline visit)
- •Patients with difference of office BP at selected one arm over DBP 10 mmHg and/or SBP 20 mmHg at screening visit
- •Patients with secondary hypertension
- •Patients with symptomatic orthostatic hypotension
- •Patients with severe insulin dependent or uncontrolled diabetes mellitus (HbA1c > 9%, increased regimen of oral hypoglycemic agent, using insulin at baseline visit)
- •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 within 6 months
- •Patients with known severe or malignancy retinopathy within 6 months
- •Patients with wasting disease, autoimmune disease, connective tissue disease
- •Patients with significant investigations - abnormal renal function (Creatinine more 1.5 times than upper limit of normal), abnormal liver function (Aspartate Transaminase(AST), Alanine Transaminase(ALT) more 2 times than upper normal)
- •Patients with surgical or medical disease which is able to be affect to absorption, distribution, metabolism, excretion
- •Patients with hereditary disorders of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption
- •Patients with significant investigations - Hypokalemia(Less than 3.5mmol/L), Hyperkalemia(exceeded 5.5mmol/L)
- •Patients with depletion of body fluid or sodium ion not able to correct
- •Patients with suspected or history of drug or alcohol abuse within the past two years
- •Childbearing, breast-feeding women and female who plan to become pregnancy or have a possibility of pregnancy but don't prevent conception with acknowledged methods
- •Patients with any chronic inflammation disease needed to chronic inflammation therapy
- •Patients with hepatitis type B or type C and carriers
- •Patients with laboratory test results indicating clinically significant abnormal results
- •Patients receiving medication that can affect blood pressure
- •Patients with history of allergic reaction to any angiotensin II antagonist
- •Patients with the medical histories of malignant tumor within 5years, except local basal cell carcinoma of the skin
- •Patients who took investigational drug 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 30 mg
Experimental
Take one capsule filled with a Fimasartan 30 mg in the every morning
干预措施: Fimasartan (Drug)
Valsartan 80 mg
Active Comparator
Take one capsule filled with a Valsartan 80 mg in the every morning
干预措施: Valsartan (Drug)
结局指标
主要结局
Mean Systolic Blood Pressure during 24 hours
时间窗: 8 weeks from baseline visit
To compare the difference of Mean Systolic Blood Pressure during 24 hours at 8 weeks from baseline visit
次要结局
- Mean Diastolic Blood Pressure during 24 hours(8 weeks from baseline visit)
- Mean Diastolic Blood pressure and Systolic Blood pressure during daytime or nighttime(8 weeks from baseline visit)
- Sitting Diastolic Blood pressure and Systolic Blood pressure(8 weeks from baseline visit)
- Trough-to-peak ratio(8 weeks from baseline visit)
- Smoothness index(8 weeks from baseline visit)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan (BR-A-657•K) During 24 Hours in Patients With Mild to Moderate Essential HypertensionEssential HypertensionNCT00922441Boryung Pharmaceutical Co., Ltd92
已完成
2 期
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 HypertensionHypertensionNCT01518998Boryung Pharmaceutical Co., Ltd420
已完成
3 期
Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan in Hypertension PatientsHypertensionNCT00922480Boryung Pharmaceutical Co., Ltd506
已完成
3 期
A Clinical Study to Evaluate Efficacy and Safety of Fimasartan/Hydrochlorothiazide Combination-therapyEssential HypertensionNCT01258673Boryung Pharmaceutical Co., Ltd263
已完成
3 期
A Randomized, Double-blind, Active Control, Parallel Group, Titration, Multicenter Study to Evaluate the Efficacy and Safety of FimasartanChronic Kidney DiseaseNCT02620306Boryung Pharmaceutical Co., Ltd351