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 Hypertension

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Fimasartan , Amlodipine, Placebo


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 20 to 75 years Essential hypertension subjects who are measured more 90mmHg, less than 114mmHg 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 115mmHg of SiDBP and/or more 185 mmHg of Sitting systolic blood pressure (SiSBP) Patients with secondary hypertension Patients with significant investigations - abnormal renal function (Creatinine more 1.5 times than upper limit of normal), abnormal liver function (AST, ALT more 2 times than upper normal), moderate fatty lever needed medication Patients with significant investigations - Hypokalemia(Less than 3.5mmol/L), Hyperkalemia(exceeded 5.5mmol/L) Patients with sodium ion or body fluid is depleted and not able to correct 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 Patients with the medical histories of malignant tumor within 5years, except local basal cell carcinoma of the skin 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: 20 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: Factorial Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Take one double-blind capsule filled with a placebo tablet in the every morning | Drug: Fimasartan , Amlodipine, Placebo<br>* Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination<br>* Other names: Norvasc;|
| Active Comparator: Fimasartan 60mg<br>Take one double-blind capsule filled with of Fimasartan 60mg in the every morning | Drug: Fimasartan , Amlodipine, Placebo<br>* Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination<br>* Other names: Norvasc;|
| Active Comparator: Fimasartan 30mg<br>Take one double-blind capsule filled with Fimasartan 30mg in the every morning | Drug: Fimasartan , Amlodipine, Placebo<br>* Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination<br>* Other names: Norvasc;|
| Active Comparator: Amlodipine 5mg<br>Take one double-blind capsule filled with Amlodipine 5mg in the every morning | Drug: Fimasartan , Amlodipine, Placebo<br>* Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination<br>* Other names: Norvasc;|
| Active Comparator: Amlodipine 10mg<br>Take one double-blind capsule filled with Amlodipine 10mg in the every morning | Drug: Fimasartan , Amlodipine, Placebo<br>* Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination<br>* Other names: Norvasc;|
| Experimental: Fimasartan 60mg/ Amlodipine 5mg<br>Take one double-blind capsule filled with Fimasartan 60mg and Amlodipine 5mg in the every morning | Drug: Fimasartan , Amlodipine, Placebo<br>* Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination<br>* Other names: Norvasc;|
| Experimental: Fimasartan 60mg/Amlodipine 10mg<br>Take one double-blind capsule filled with Fimasartan 60mg and Amlodipine 10mg in the every morning | Drug: Fimasartan , Amlodipine, Placebo<br>* Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination<br>* Other names: Norvasc;|
| Experimental: Fimasartan 30mg/Amlodipine 5mg<br>Take one double-blind capsule filled with Fimasartan 30mg and Amlodipine 5mg in the every morning | Drug: Fimasartan , Amlodipine, Placebo<br>* Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination<br>* Other names: Norvasc;|
| Experimental: Fimasartan 30mg/Amlodipine 10mg<br>Take one double-blind capsule filled with Fimasartan 30mg and Amlodipine 10mg in the every morning | Drug: Fimasartan , Amlodipine, Placebo<br>* Fimasartan 60mg, Fimasartan 30mg, Amlodipine 5mg, Amlodipine 10mg, Placebo, Fimasartan 60mg/Amlodipine 5mg combination, Fimasartan 60mg/Amlodipine 10mg combination, Fimasartan 30mg/Amlodipine 5mg combination, Fimasartan 30mg/Amlodipine 10mg combination<br>* Other names: Norvasc;|

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 8 weeks from baseline visit | 8weeks from baseline visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sitting Systolic Blood Pressure | To compare the difference of Sitting Systolic Blood Pressure at 4,8 weeks from baseline visit | at 4 and 8 weeks from Baseline visit | 
| Sitting Diastolic Blood Pressure | To compare the difference of Sitting Diastolic Blood Pressure at 4 weeks from baseline visit | 4weeks from baseline visit | 
| Responder ratio | To compare the ratio or responder(SiDBP<90mmHg or difference of SiDBP>10mmHg from baseline) at 8 weeks | at 8weeks from baseline visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fimasartan, Amlodipine, antihypertension