Efficacy of fimaSartan on arTerIal stiFFness iN patiEntS With HypertenSion

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effects of fimasartan on arterial stiffness in patients with hypertension

Official Title
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A Single-arm, Open, Clinical Study to Evaluate the Effects of Fimasartan on Arterial Stiffness in Patients With Hypertension

Conditions
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Hypertension

Intervention / Treatment
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* Drug: Fimasartan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who agree to participate in this study and give written informed consent Subjects whose sitting diastolic blood pressure measured at placebo visit and baseline are more than 90 mmHg and/or systolic blood pressure are more than 140 mmHg Subjects who are naive to anti-hypertensive treatment Subjects considered to understand the study, be cooperative, and able to be followed-up until the end of the study Exclusion Criteria: Subjects who are hypersensitive to angiotensin type 1-receptor blockers Subjects with secondary hypertension Subjects with severe hypertension (systolic blood pressure >= 180 mmHg OR diastolic blood pressure >= 110) Severe cardiac disease (heart failure, ischemic heart disease, peripheral vascular disease, moderate valvular disease, arrhythmia requiring treatment, cardiomyopathy, etc.) Subjects with chronic obstructive pulmonary disease or history Clinically significant renal dysfunction (Creatinine 2.0 mg/dL) and liver dysfunction (ALT, AST > 2x UNL) Subjects with life expectancy of less than 2 years due to non-cardiac disease Subjects with history or evidence of abuse of drugs or alcohol within 2 years Severe insulin-dependent diabetes mellitus or intractable diabetic patient (dose/regimen change of oral hypoglycemic agent, insulin use) Severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, within 6 months) Wasting diseases, autoimmune diseases (rheumatoid arthritis, systemic lupus anticoagulants, etc.), history of connective tissue disease or ongoing disease. Women with pregnancy and breast feeding Women planning to be pregnant or without admitted contraception despite of probability of pregnancy (Women who underwent sterilization operation are excluded. Fertile women without such surgery should undergo pregnancy test and can participate only with negative result. Intermittent abstinence like basic body temperature method, natural period method are not considered admitted contraception and no hormonal contraception is allowed.). Subjects who are participating in other clinical trials for investigating agents or have taken other clinical trial medication within 4 weeks before screening visit. Subjects judged to be inappropriate by the investigator

Ages Eligible for Study
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Minimum Age: 18 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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fimasartan|Fimasartan 60   120 mg/po take one tablet once a day|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of carotid radial strain value | Improvement of carotid arterial stiffness measured by echocardiography | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in brachial-ankle pulse wave velocity (baPWV) |  | 24 weeks | 
| Improvement in augmentation index (AIx) |  | 24 weeks | 
| Improvement in carotid distensibility |  | 24 weeks | 
| Improvement in sitting systolic blood pressure (SiSBP) |  | 24 weeks | 
| Improvement in sitting diastolic blood pressure (SiDBP) |  | 24 weeks | 
| Improvement in central blood pressure (BP) |  | 24 weeks |