Back to resultsBR1010 in Patients With Essential Hypertension Patients Who do Not Adequately Respond to Fimasartan/Amlodipine Combination (FINAL)
Primary Purpose
Essential Hypertension
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Fimasartan/Amlodipine
Sponsored by
About this trial
This is an interventional treatment trial for Essential Hypertension
Eligibility Criteria
Inclusion Criteria:
1.Voluntarily provided a written consent to participate in this clinical study 2.19 years old or above Koreans living in Korea 3.Patients with uncontrolled essential hypertension at screening time(Visit 1)
- Use antihypertensive drugs:140 mmHg ≤ sitSBP < 200 mmHg
- Naïve: 160 mmHg ≤ sitSBP < 200 mmHg 4.Patients with uncontrolled hypertension after Fimasartan/Amlodipine 30/5mg treatment for 4 weeks at randomization(Visit 2) (Selected Arm:140 mmHg ≤ sitSBP < 200 mmHg 5.Able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion
Exclusion Criteria:
- Difference of SiSBP ≥ 20 mmHg and SiDBP ≥ 10 mmHg in 3 blood pressure measurements in the selected reference arm at the screening visit
- Blood pressure results showing sitDBP ≥ 120 mmHg at screening and baseline visit(Visit 1; Both Arm, Visit 2: Selected Arm)
- Treatment Compliance of Fimasartan/Amlodipine 30/5mg < 70%
- Heart failure(New York Heart Association class 3 and 4), ischemic heart disease, peripheral vascular disease
- Percutaneous Coronary Artery within 6 months prior to study
- Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter; or other arrhythmia conditions that are determined to be clinically significant by the investigator
- Patients who have history of severe cerebrovascular disease within 6 months prior to study
- Type I Diabetes Mellitus or Uncontrolled Type II Diabetes Mellitus(HbA1c > 9% at screening visit
- Patients who have history of severe or malignant retinopathy within 6 months prior to study
- Pregnant or lactating women
- Planning pregnancy during the study period or have childbearing potential but are not using acceptable contraceptive methods
- Patients taking other clinical trial drugs within 4 weeks from the time of visit for screening
- Patients who are judged unsuitable to participate in this study by investigator
Sites / Locations
- Boryung Pharmaceutical Co., Ltd
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
BR1010 and Fimasartan/Amlodipine placebo
BR1010 placebo and Fimasartan/Amlodipine
Arm Description
BR1010 or Fimasartan/Amlodipine
BR1010 or Fimasartan/Amlodipine
Outcomes
Primary Outcome Measures
sitting systolic blood pressure
The change of sitting systolic blood pressure
Secondary Outcome Measures
sitting systolic blood pressure
The change of sitting systolic blood pressure
sitting systolic blood pressure and sitting diastolic blood pressure
The change of sitting systolic blood pressure and sitting diastolic blood pressure
The ratio of subjects who get normalized blood pressure
The ratio of subjects who get normalized blood pressure
Response Rate
Response Rate
Full Information
NCT ID
NCT03991442
First Posted
June 17, 2019
Last Updated
July 28, 2021
Sponsor
Boryung Pharmaceutical Co., Ltd
1. Study Identification
Unique Protocol Identification Number
NCT03991442
Brief Title
BR1010 in Patients With Essential Hypertension Patients Who do Not Adequately Respond to Fimasartan/Amlodipine Combination
Acronym
FINAL
Official Title
A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of BR1010 in Essential Hypertension Patients Who do Not Adequately Respond to Fimasartan/Amlodipine Combination
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 17, 2019 (Actual)
Primary Completion Date
March 2, 2021 (Actual)
Study Completion Date
March 2, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boryung Pharmaceutical Co., Ltd
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The objective of this clinical study is to evaluate the efficacy and safety by comparing the BR1010 treatment group to the fimasartan/amlodipine treatment group at Week 8 in patients with essential hypertension who do not adequately respond to Fimasartan/Amlodipine combination
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Essential Hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
257 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BR1010 and Fimasartan/Amlodipine placebo
Arm Type
Experimental
Arm Description
BR1010 or Fimasartan/Amlodipine
Arm Title
BR1010 placebo and Fimasartan/Amlodipine
Arm Type
Active Comparator
Arm Description
BR1010 or Fimasartan/Amlodipine
Intervention Type
Drug
Intervention Name(s)
Fimasartan/Amlodipine
Other Intervention Name(s)
BR1010 or placebo
Intervention Description
Active Comparator: a fixed dose combination of Fimasartan/Amlodipine or placebo
Primary Outcome Measure Information:
Title
sitting systolic blood pressure
Description
The change of sitting systolic blood pressure
Time Frame
8weeks from Baseline Visit
Secondary Outcome Measure Information:
Title
sitting systolic blood pressure
Description
The change of sitting systolic blood pressure
Time Frame
2weeks and 4weeks from Baseline Visit
Title
sitting systolic blood pressure and sitting diastolic blood pressure
Description
The change of sitting systolic blood pressure and sitting diastolic blood pressure
Time Frame
2weeks, 4weeks and 8weeks from Baseline Visit
Title
The ratio of subjects who get normalized blood pressure
Description
The ratio of subjects who get normalized blood pressure
Time Frame
2weeks, 4weeks and 8weeks from Baseline Visit
Title
Response Rate
Description
Response Rate
Time Frame
2weeks, 4weeks and 8weeks from Baseline Visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
1.Voluntarily provided a written consent to participate in this clinical study 2.19 years old or above Koreans living in Korea 3.Patients with uncontrolled essential hypertension at screening time(Visit 1)
Use antihypertensive drugs:140 mmHg ≤ sitSBP < 200 mmHg
Naïve: 160 mmHg ≤ sitSBP < 200 mmHg 4.Patients with uncontrolled hypertension after Fimasartan/Amlodipine 30/5mg treatment for 4 weeks at randomization(Visit 2) (Selected Arm:140 mmHg ≤ sitSBP < 200 mmHg 5.Able to understand this study, be cooperative in the execution of the study, and participate in the study until its completion
Exclusion Criteria:
Difference of SiSBP ≥ 20 mmHg and SiDBP ≥ 10 mmHg in 3 blood pressure measurements in the selected reference arm at the screening visit
Blood pressure results showing sitDBP ≥ 120 mmHg at screening and baseline visit(Visit 1; Both Arm, Visit 2: Selected Arm)
Treatment Compliance of Fimasartan/Amlodipine 30/5mg < 70%
Heart failure(New York Heart Association class 3 and 4), ischemic heart disease, peripheral vascular disease
Percutaneous Coronary Artery within 6 months prior to study
Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter; or other arrhythmia conditions that are determined to be clinically significant by the investigator
Patients who have history of severe cerebrovascular disease within 6 months prior to study
Type I Diabetes Mellitus or Uncontrolled Type II Diabetes Mellitus(HbA1c > 9% at screening visit
Patients who have history of severe or malignant retinopathy within 6 months prior to study
Pregnant or lactating women
Planning pregnancy during the study period or have childbearing potential but are not using acceptable contraceptive methods
Patients taking other clinical trial drugs within 4 weeks from the time of visit for screening
Patients who are judged unsuitable to participate in this study by investigator
Facility Information:
Facility Name
Boryung Pharmaceutical Co., Ltd
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
BR1010 in Patients With Essential Hypertension Patients Who do Not Adequately Respond to Fimasartan/Amlodipine Combination
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