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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

351 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-02-11

Study Completion Date

2022-05-11

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.

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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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Fimasartan(A)

Group Type EXPERIMENTAL

Fimsartan 60mg~120mg

Intervention Type DRUG

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.

Fimasartan(B)

Group Type EXPERIMENTAL

Fimsartan 60mg~120mg

Intervention Type DRUG

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.

Losartan(A)

Group Type ACTIVE_COMPARATOR

Losartan 50mg~100mg

Intervention Type DRUG

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.

Losartan(B)

Group Type ACTIVE_COMPARATOR

Losartan 50mg~100mg

Intervention Type DRUG

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.

Interventions

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Fimsartan 60mg~120mg

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.

Intervention Type DRUG

Fimsartan 60mg~120mg

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.

Intervention Type DRUG

Losartan 50mg~100mg

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.

Intervention Type DRUG

Losartan 50mg~100mg

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.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

1. Male and female adults aged 19 years or older
2. 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
3. eGFR: ≥ 30 ml/min/1.73 m2 within the past 6 months
4. 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.
5. Patients with diabetes
6. Voluntarily provided a written consent to participate
7. Able to understand this study, be cooperative in the execution of the study

Exclusion Criteria

1. Severe hypertension with mean SBP ≥ 180 mmHg or DBP ≥ 110 mmHg
2. Orthostatic hypotension with symptoms
3. Insulin dependent diabetes mellitus or uncontrolled diabetes mellitus
4. Patients on dialysis, patients with clinically significant cardiac and hepatic diseases

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No