A Randomized, Double-blind, Active Control, Parallel Group, Titration, Multicenter Study to Evaluate the Efficacy and Safety of Fimasartan

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the Efficacy and Safety of Fimasartan in patients with hypertensive diabetic chronic kidney disease.

Detailed Description
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The randomized subjects will take the investigational product (Fimasartan or Losartan) corresponding to each treatment group for 24 weeks. After that, all subjects will take Fimasartan for additional 120 weeks in an open-label, 2-parallel group study conducted with 2 groups in accordance with the blood pressure control criteria.

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Drug: Fimsartan 60mg 120mg
* Drug: Fimsartan 60mg 120mg
* Drug: Losartan 50mg 100mg
* Drug: Losartan 50mg 100mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male and female adults aged 19 years or older Blood pressure: Mean blood pressure is as below at screening. For treatment-naïve patients: 140 mmHg ≤ SBP < 180 mmHg and DBP < 110 mmHg For patients who are taking ACEI or ARB: 130 mmHg ≤ SBP < 180 mmHg and DBP < 110 mmHg eGFR: ≥ 30 ml/min/1.73 m2 within the past 6 months Albuminuria (ACR) excretion volume: Meets one or more of the following conditions ACR > 300 mg/g (or mg/day) within the past 12 months There are at least two results of 30 ≤ ACR ≤ 300 mg/g (or mg/day) within the past 12 months and the interval between the two test is at least 12 weeks. Patients with diabetes Voluntarily provided a written consent to participate Able to understand this study, be cooperative in the execution of the study Exclusion Criteria: Severe hypertension with mean SBP ≥ 180 mmHg or DBP ≥ 110 mmHg Orthostatic hypotension with symptoms Insulin dependent diabetes mellitus or uncontrolled diabetes mellitus Patients on dialysis, patients with clinically significant cardiac and hepatic diseases

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fimasartan(A)<br> | Drug: Fimsartan 60mg 120mg<br>* Standard BP control group (SBP < 140 mmHg). In case of patients with blood pressure that cannot be controlled to the targeted level during the entire clinical study period, the dose of study drug is increased or other antihypertensive drugs are administered concomitantly.<br>|
| Experimental: Fimasartan(B)<br> | Drug: Fimsartan 60mg 120mg<br>* Strict BP control group (SBP < 130 mmHg). In case of patients with blood pressure that cannot be controlled to the targeted level at each visit during the entire clinical study period, the dose of study drug is increased or other antihypertensive drugs are administered concomitantly.<br>|
| Active Comparator: Losartan(A)<br> | Drug: Losartan 50mg 100mg<br>* Standard BP control group (SBP < 140 mmHg). In case of patients with blood pressure that cannot be controlled to the targeted level during the entire clinical study period, the dose of study drug is increased or other antihypertensive drugs are administered concomitantly.<br>|
| Active Comparator: Losartan(B)<br> | Drug: Losartan 50mg 100mg<br>* Strict BP control group (SBP < 130 mmHg). In case of patients with blood pressure that cannot be controlled to the targeted level at each visit during the entire clinical study period, the dose of study drug is increased or other antihypertensive drugs are administered concomitantly.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare and evaluate the rate of change in albuminuria |  | 6months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time to the first occurrence of the cardiovascular composite endpoint in accordance with the blood pressure control criteria | Cardiovascular composite endpoint: Occurrence of myocardial infarction (MI) and stroke; hospitalization due to heart failure and unstable angina; coronary revascularization and peripheral revascularization; and all caused death | 36months | 
| The time to the first occurrence of the renal composite endpoint in accordance with the blood pressure control criteria | Renal composite endpoint: The time point where the reduction in eGFR of ≥ 50% compared with baseline eGFR; the time where the progression to ESRD is confirmed (in case of the initiation of long-term dialysis or renal transplantation); all caused death | 36months | 
| The time to the first occurrence of the combined cardiovascular and renal composite endpoint in accordance with the blood pressure control criteria |  | 36months |