search
Back to results

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

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fimsartan 60mg~120mg
Fimsartan 60mg~120mg
Losartan 50mg~100mg
Losartan 50mg~100mg
Sponsored by
Boryung Pharmaceutical Co., Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Severance hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Fimasartan(A)

Fimasartan(B)

Losartan(A)

Losartan(B)

Arm Description

Outcomes

Primary Outcome Measures

To compare and evaluate the rate of change in albuminuria

Secondary Outcome Measures

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
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
The time to the first occurrence of the combined cardiovascular and renal composite endpoint in accordance with the blood pressure control criteria

Full Information

First Posted
December 1, 2015
Last Updated
May 24, 2022
Sponsor
Boryung Pharmaceutical Co., Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT02620306
Brief Title
A Randomized, Double-blind, Active Control, Parallel Group, Titration, Multicenter Study to Evaluate the Efficacy and Safety of Fimasartan
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
February 11, 2016 (Actual)
Primary Completion Date
December 23, 2019 (Actual)
Study Completion Date
May 11, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boryung Pharmaceutical Co., Ltd

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
351 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fimasartan(A)
Arm Type
Experimental
Arm Title
Fimasartan(B)
Arm Type
Experimental
Arm Title
Losartan(A)
Arm Type
Active Comparator
Arm Title
Losartan(B)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Fimsartan 60mg~120mg
Intervention Description
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
Intervention Name(s)
Fimsartan 60mg~120mg
Intervention Description
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
Intervention Name(s)
Losartan 50mg~100mg
Intervention Description
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
Intervention Name(s)
Losartan 50mg~100mg
Intervention Description
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.
Primary Outcome Measure Information:
Title
To compare and evaluate the rate of change in albuminuria
Time Frame
6months
Secondary Outcome Measure Information:
Title
The time to the first occurrence of the cardiovascular composite endpoint in accordance with the blood pressure control criteria
Description
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
Time Frame
36months
Title
The time to the first occurrence of the renal composite endpoint in accordance with the blood pressure control criteria
Description
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
Time Frame
36months
Title
The time to the first occurrence of the combined cardiovascular and renal composite endpoint in accordance with the blood pressure control criteria
Time Frame
36months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Severance hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

Citations:
PubMed Identifier
29284530
Citation
Kim JY, Son JW, Park S, Yoo TH, Kim YJ, Ryu DR, Chin HJ. FimAsartaN proTeinuriA SusTaIned reduCtion in comparison with losartan in diabetic chronic kidney disease (FANTASTIC): study protocol for randomized controlled trial. Trials. 2017 Dec 29;18(1):632. doi: 10.1186/s13063-017-2375-8.
Results Reference
derived

Learn more about this trial

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

We'll reach out to this number within 24 hrs