A Valsartan 80 Mg-Referenced, Therapeutic Exploratory Clinical Study to Evaluate the Antihypertensive Efficacy of Fimasartan 30 mg During 24 Hours in Patients With Mild to Moderate Essential Hypertension
2014年9月5日 更新者:Boryung Pharmaceutical Co., Ltd
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
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
研究概览
研究类型
介入性
注册 (实际的)
75
阶段
- 阶段2
联系人和位置
本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。
学习地点
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Seoul、大韩民国、110-744
- Seoul National University Hospital
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参与标准
研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 至 70年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
学习计划
本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的:Fimasartan 30 mg
Take one capsule filled with a Fimasartan 30 mg in the every morning
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Fimasartan 30 mg
其他名称:
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有源比较器:Valsartan 80 mg
Take one capsule filled with a Valsartan 80 mg in the every morning
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Valsartan 80 mg
其他名称:
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Mean Systolic Blood Pressure during 24 hours
大体时间:8 weeks from baseline visit
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To compare the difference of Mean Systolic Blood Pressure during 24 hours at 8 weeks from baseline visit
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8 weeks from baseline visit
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
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Mean Diastolic Blood Pressure during 24 hours
大体时间:8 weeks from baseline visit
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To compare the difference of Mean Diastolic Blood Pressure during 24 hours at 8 weeks from baseline visit
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8 weeks from baseline visit
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Mean Diastolic Blood pressure and Systolic Blood pressure during daytime or nighttime
大体时间:8 weeks from baseline visit
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To compare the difference of Diastolic Blood pressure and Systolic Blood pressure during daytime or nighttime at 8 weeks from baseline visit
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8 weeks from baseline visit
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Sitting Diastolic Blood pressure and Systolic Blood pressure
大体时间:8 weeks from baseline visit
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To compare the difference of Sitting Diastolic Blood pressure and Systolic Blood pressure at 8 weeks from baseline visit
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8 weeks from baseline visit
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Trough-to-peak ratio
大体时间:8 weeks from baseline visit
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Trough-to-peak ratio of systolic blood pressure and diastolic blood pressure measured by ABP(Ambulatory Blood Pressure) monitor
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8 weeks from baseline visit
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Smoothness index
大体时间:8 weeks from baseline visit
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Smoothness index of systolic blood pressure and diastolic blood pressure measured by ABP monitor
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8 weeks from baseline visit
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
---|---|---|
Adverse events
大体时间:about 10~11weeks from placebo run-in visit
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Adverse evnt(AE)s are collected as a safety measure.
All AEs are arranged based on severity, relevance to the investigational drug and serious adverse event each.
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about 10~11weeks from placebo run-in visit
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Adverse changes in laboratory test results
大体时间:about 10~11weeks from screening visit
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Adverse changes in laboratory test results are collected as a safety measure.
As a continuous data group for each test visit, adverse changes in laboratory test results present descriptive statistics (mean, standard deviation, minimum, maximum, etc.)
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about 10~11weeks from screening visit
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Adverse changes in electrocardiography(ECG)
大体时间:about 10~11weeks from screening visit
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Adverse changes in ECG are collected as a safety measure.
As a categorical data, adverse changes in ECG present frequency and percentage for each category.
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about 10~11weeks from screening visit
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 学习椅:Byung-He Oh, professor、Seoul National University Hospital
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2013年5月1日
初级完成 (实际的)
2014年2月1日
研究完成 (实际的)
2014年2月1日
研究注册日期
首次提交
2013年5月31日
首先提交符合 QC 标准的
2013年6月12日
首次发布 (估计)
2013年6月14日
研究记录更新
最后更新发布 (估计)
2014年9月8日
上次提交的符合 QC 标准的更新
2014年9月5日
最后验证
2014年9月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- A657-BR-CT-L201
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
Fimasartan的临床试验
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Boryung Pharmaceutical Co., Ltd完全的