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

Study Overview
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Brief Summary
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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

Official Title
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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

Conditions
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Essential Hypertension

Intervention / Treatment
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* Drug: Fimasartan
* Drug: Valsartan


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fimasartan 30 mg<br>Take one capsule filled with a Fimasartan 30 mg in the every morning | Drug: Fimasartan<br>* Fimasartan 30 mg<br>* Other names: Kanarb;|
| Active Comparator: Valsartan 80 mg<br>Take one capsule filled with a Valsartan 80 mg in the every morning | Drug: Valsartan<br>* Valsartan 80 mg<br>* Other names: Diovan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Systolic Blood Pressure during 24 hours | To compare the difference of Mean Systolic Blood Pressure during 24 hours at 8 weeks from baseline visit | 8 weeks from baseline visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Diastolic Blood Pressure during 24 hours | To compare the difference of Mean Diastolic Blood Pressure during 24 hours at 8 weeks from baseline visit | 8 weeks from baseline visit | 
| Mean Diastolic Blood pressure and Systolic Blood pressure during daytime or nighttime | To compare the difference of Diastolic Blood pressure and Systolic Blood pressure during daytime or nighttime at 8 weeks from baseline visit | 8 weeks from baseline visit | 
| Sitting Diastolic Blood pressure and Systolic Blood pressure | To compare the difference of Sitting Diastolic Blood pressure and Systolic Blood pressure at 8 weeks from baseline visit | 8 weeks from baseline visit | 
| Trough-to-peak ratio | Trough-to-peak ratio of systolic blood pressure and diastolic blood pressure measured by ABP(Ambulatory Blood Pressure) monitor | 8 weeks from baseline visit | 
| Smoothness index | Smoothness index of systolic blood pressure and diastolic blood pressure measured by ABP monitor | 8 weeks from baseline visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fimasartan, 24 hours ABP monitoring(ABPM), antihypertension