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
About this trial
This is an interventional treatment trial for Chronic Kidney Disease
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
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
NCT ID
NCT02620306
First Posted
December 1, 2015
Last Updated
May 24, 2022
Sponsor
Boryung Pharmaceutical Co., Ltd
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