A Clinical Study to Evaluate Efficacy and Safety of Fimasartan/Hydrochlorothiazide Combination-therapy

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/Hydrochlorothiazide combination 60/12.5mg 120/12.5mg in patients with essential hypertension who are not controlled by fimasartan 60mg.

Official Title
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A Randomized, Double-blind, Multicenter Clinical Study to Evaluate Efficacy and Safety of Fimasartan/Hydrochlorothiazide Combination-therapy in Comparison With Fimasartan Monotherapy for Essential Hypertension Patients Not Controlled by Fimasartan 60mg(Phase 3)

Conditions
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Essential Hypertension

Intervention / Treatment
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* Drug: Fimasartan/HCTZ combination
* Drug: Fimasartan


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female outpatients 18 years of age and older Patients with antihypertensive agents at screening: DBP<110mmHg or Patients without antihypertensive agents at screening: DBP 90mmHg 120mmHg Subjects who agree to participate in this sudy and give written informed consent Subjects considered to understand the study, be cooperative, and able to be followed-up until the end of the study Patients with not controlled blood pressure at baseline visit, by fimasartan 60mg 4weeks treatment, DBP 90mmHg 109mmHg and SBP<180mmHg Exclusion Criteria: The sitting DBP is more than 120mmHg or severe hypertensive patient with sitting systolic blood pressure over 200mmHg Patients with secondary hypertension Patients who are measured the mean difference of mean blood pressure under SiDBP 10mmHg or SiSBP 20mmHg at screening or baseline visit Patients with severe renal(Creatinine more 1.5 times than upper limit of normal), gastrointestinal, hematological or hepatic(AST, ALT more 2 twice more than upper limit of normal)disease etc. which might affect absorption, disposition, metabolism or excretion of the drug Patients with postural hypotension Patients with sever insulin dependent diabetes mellitus or uncontrolled diabetes mellitus(HbA1c>9%, regimen change of oral hypoglycemic agents within 12weeks, treated insulin before screening) Patients with a history of myocardial infarction, severe coronary artery disease or clinically significant heart failure or valvular defect in last 6 months Patients with consumptive disease, autoimmune disease, connective tissue disease Patients with a history of type B or C hepatitis(include carrier) Patients with HIV or hepatitis Patients with clinically significant laboratory abnormality Patients receiving any drugs known to affect blood pressure or medical treatments that can influence the blood pressure Patients with allergy or contraindication to any angiotensin II receptor antagonists Female of childbearing potential who does not undergo hysterectomy or is not post-menopausal Patients judged to have a history of alcohol or drug abuse by the investigator Patients participated other clinical trial 12 weeks before Screening - Patients judged to be inappropriate for this study by the investigator with other reasons

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Experimental: Fimasartan/HCTZ combination group<br> | Drug: Fimasartan/HCTZ combination<br>* Fimasartan/HCTZ combination 60/12.5mg 120/12.5mg<br>|
| Active Comparator: Fimasartan group<br> | Drug: Fimasartan<br>* Fimasartan 60mg, 120mg<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diastolic Blood Pressure |  | 4week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Blood Pressure / Diastolic Blood Pressure |  | 4week, 8week / 8week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fimasartan, Fimasartan/Hydrochlorothiazide combination