The Clinical Study to Evaluate the Efficacy and Safety of Fimasartan in Patients With Mild to Moderate Essential Hypertension

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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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)

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Fimasartan 60mg
* Drug: Fimasartan 120mg
* Drug: Candesartan cilexetil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 75 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Fimasartan 60mg<br>Take one tablet of Fimasartan 60mg once a day in the morning | Drug: Fimasartan 60mg<br>* Fimasartan 60mg for mild to moderate hypertension. Take a tablet(filled in Doubleblind capsule) every morning.<br>|
| Active Comparator: Fimasartan 120mg<br>Take one tablet of Fimasartan 120mg once a day in the morning | Drug: Fimasartan 120mg<br>* Fimasartan 120mg for mild to moderate hypertension. Take a tablet(filled in Doubleblind capsule) every morning.<br>|
| Active Comparator: Candesartan 8mg<br>Take one tablet of Candesartan 8mg once a day in the morning | Drug: Candesartan cilexetil<br>* Candesartan 8mg for mild to moderate hypertension. Take a tablet(filled in Doubleblind capsule) every morning.<br>* Other names: Atacand 8mg;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sitting Diastolic Blood Pressure | To compare the difference of Sitting Diastolic Blood Pressure at 12 weeks from baseline visit Fimasartan 60mg with Candesartna 8mg | 12weeks from baseline visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sitting DBP | To compare the difference of Sitting Diastolic Blood Pressure at 12 weeks from baseline visit Fimasartan 120mg with Candesartna 8mg | at 12weeks from Baseline visit | 
| SittingDBP | To compare the difference of Sitting Diastolic Blood Pressure at 4, 8 weeks from baseline visit Fimasartan 60/120mg with Candesartna 8mg | at 4, 8 weeks from baseline visit | 
| Sitting Systolic Blood Pressure | To compare the difference of Sitting Systolic Blood Pressure at 4,8,12 weeks from baseline visit Fimasartan 60mg/120mg with Candesartna 8mg | at 4,8,12 weeks from baseline visit | 
| Responder ratio | To compare the ratio or responder(SiDBP<90mmHg or difference of SiDBP>10mmHg from baseline) at 12 weeks Fimasartan 60mg/120mg with Candesartna 8mg | at 12weeks from baseline visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, ARB, Fimasartan