A Study to Evaluate the Efficacy and Safety of BR1015 Combination Therapy

Study Overview
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Brief Summary
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The objective of this clinical trial is to evaluate the efficacy and safety of BR1015 Combination therapy group in comparison with Fimasartan monotherapy group at Week 8 for essential hypertension patients who do not adequately responded by Fimasartan 30 mg

Official Title
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A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of BR1015 Combination Therapy in Comparison With Fimasartan Monotherapy for Essential Hypertension Patients Not Adequately Responded by Fimasartan 30 mg

Conditions
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Essential Hypertension

Intervention / Treatment
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* Drug: Fimasartan + Indapamide
* Drug: Fimasartan + Indapamide placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with uncontrolled essential hypertension at screening(V1) under the following criteria: Naïve : 140 mmHg ≤ SiSBP < 180 mmHg Use antihypertensive drugs : 130 mmHg ≤ SiSBP < 180 mmHg Patients with uncontrolled essential hypertension at randomization(V2) after Fimasartan 30mg monotherapy for 4 weeks under the following criteria: Selected reference arm : 140 mmHg ≤ SiSBP < 180 mmHg (For patients with cardiovascular disease, diabetes or chronic kidney disease (CKD) with albuminuria, 130 mmHg ≤ SiSBP < 180 mmHg) Treatment compliance of Fimasartan 30 mg ≥70% at baseline visit (V2) Voluntarily provided a written consent to participate in this clinical study Able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion Exclusion Criteria: Patients taking three or more antihypertensive drugs of different families Patients with blood pressure results showing SiSBP ≥ 180 mmHg or SiDBP ≥ 110 mmHg in the selected reference arm at screening(V1) and randomization(V2) Patients with a difference of SiSBP ≥ 20 mmHg and SiDBP ≥ 10 mmHg in blood pressure measured three times on both arms at screening(V1) Patients with secondary hypertension: Secondary hypertension is not limited to the following diseases; (e.g., coarctation of the aorta, Primary hyperaldosteronism, renal artery stenosis, Cushing's syndrome, pheochromocytoma and polycystic kidney disease, etc.) Patients with orthostatic hypotension accompanied by symptoms Patients who need to be administered in combination with antihypertensive drugs other than investigational product while participating in clinical trials

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fimasartan + Indapamide<br>Treatment Period I, II | Drug: Fimasartan + Indapamide<br>* a fixed dose combination<br>* Other names: I : BR1015-3 + BR1015-2, II : BR1015-1 + BR1015-2;|
| Active Comparator: Fimasartan + Indapamide placebo<br>Treatment Period I, II | Drug: Fimasartan + Indapamide placebo<br>* a fixed dose combination<br>* Other names: I : BR1015-3 + BR1015-4, II : BR1015-1 + BR1015-4;|

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 | 4weeks from Baseline Visit |