BR1010 in Patients With Essential Hypertension Patients Who do Not Adequately Respond to Fimasartan/Amlodipine Combination

Study Overview
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Brief Summary
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The objective of this clinical study is to evaluate the efficacy and safety by comparing the BR1010 treatment group to the fimasartan/amlodipine treatment group at Week 8 in patients with essential hypertension who do not adequately respond to Fimasartan/Amlodipine combination

Official Title
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A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of BR1010 in Essential Hypertension Patients Who do Not Adequately Respond to Fimasartan/Amlodipine Combination

Conditions
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Essential Hypertension

Intervention / Treatment
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* Drug: Fimasartan/Amlodipine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1.Voluntarily provided a written consent to participate in this clinical study 2.19 years old or above Koreans living in Korea 3.Patients with uncontrolled essential hypertension at screening time(Visit 1) Use antihypertensive drugs:140 mmHg ≤ sitSBP < 200 mmHg Naïve: 160 mmHg ≤ sitSBP < 200 mmHg 4.Patients with uncontrolled hypertension after Fimasartan/Amlodipine 30/5mg treatment for 4 weeks at randomization(Visit 2) (Selected Arm:140 mmHg ≤ sitSBP < 200 mmHg 5.Able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion Exclusion Criteria: Difference of SiSBP ≥ 20 mmHg and SiDBP ≥ 10 mmHg in 3 blood pressure measurements in the selected reference arm at the screening visit Blood pressure results showing sitDBP ≥ 120 mmHg at screening and baseline visit(Visit 1; Both Arm, Visit 2: Selected Arm) Treatment Compliance of Fimasartan/Amlodipine 30/5mg < 70% Heart failure(New York Heart Association class 3 and 4), ischemic heart disease, peripheral vascular disease Percutaneous Coronary Artery within 6 months prior to study Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter; or other arrhythmia conditions that are determined to be clinically significant by the investigator Patients who have history of severe cerebrovascular disease within 6 months prior to study Type I Diabetes Mellitus or Uncontrolled Type II Diabetes Mellitus(HbA1c > 9% at screening visit Patients who have history of severe or malignant retinopathy within 6 months prior to study Pregnant or lactating women Planning pregnancy during the study period or have childbearing potential but are not using acceptable contraceptive methods Patients taking other clinical trial drugs within 4 weeks from the time of visit for screening Patients who are judged unsuitable to participate in this study by investigator

Ages Eligible for Study
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Minimum Age: 19 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: BR1010 and Fimasartan/Amlodipine placebo<br>BR1010 or Fimasartan/Amlodipine | Drug: Fimasartan/Amlodipine<br>* Active Comparator: a fixed dose combination of Fimasartan/Amlodipine or placebo<br>* Other names: BR1010 or placebo;|
| Active Comparator: BR1010 placebo and Fimasartan/Amlodipine<br>BR1010 or Fimasartan/Amlodipine | Drug: Fimasartan/Amlodipine<br>* Active Comparator: a fixed dose combination of Fimasartan/Amlodipine or placebo<br>* Other names: BR1010 or placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sitting systolic blood pressure | The change of sitting systolic blood pressure | 8weeks from Baseline Visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sitting systolic blood pressure | The change of sitting systolic blood pressure | 2weeks and 4weeks from Baseline Visit | 
| sitting systolic blood pressure and sitting diastolic blood pressure | The change of sitting systolic blood pressure and sitting diastolic blood pressure | 2weeks, 4weeks and 8weeks from Baseline Visit | 
| The ratio of subjects who get normalized blood pressure | The ratio of subjects who get normalized blood pressure | 2weeks, 4weeks and 8weeks from Baseline Visit | 
| Response Rate | Response Rate | 2weeks, 4weeks and 8weeks from Baseline Visit |