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出境医 / 临床实验 / BR1010 in Patients With Essential Hypertension Patients Who do Not Adequately Respond to Fimasartan/Amlodipine Combination (FINAL)

BR1010 in Patients With Essential Hypertension Patients Who do Not Adequately Respond to Fimasartan/Amlodipine Combination (FINAL)

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

Condition or disease Intervention/treatment Phase
Essential Hypertension Drug: Fimasartan/Amlodipine Phase 3

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
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
Actual Study Start Date : June 17, 2019
Estimated Primary Completion Date : September 1, 2021
Estimated Study Completion Date : September 1, 2021
Arms and Interventions
Arm Intervention/treatment
Experimental: BR1010 and Fimasartan/Amlodipine placebo
BR1010 or Fimasartan/Amlodipine
 Drug: Fimasartan/Amlodipine
Active Comparator: a fixed dose combination of Fimasartan/Amlodipine or placebo
Other Name: BR1010 or placebo
Active Comparator: BR1010 placebo and Fimasartan/Amlodipine
BR1010 or Fimasartan/Amlodipine
 Drug: Fimasartan/Amlodipine
Active Comparator: a fixed dose combination of Fimasartan/Amlodipine or placebo
Other Name: BR1010 or placebo
Outcome Measures
Primary Outcome Measures :
  1. sitting systolic blood pressure [ Time Frame: 8weeks from Baseline Visit ]
    The change of sitting systolic blood pressure


Secondary Outcome Measures :
  1. sitting systolic blood pressure [ Time Frame: 2weeks and 4weeks from Baseline Visit ]
    The change of sitting systolic blood pressure

  2. sitting systolic blood pressure and sitting diastolic blood pressure [ Time Frame: 2weeks, 4weeks and 8weeks from Baseline Visit ]
    The change of sitting systolic blood pressure and sitting diastolic blood pressure

  3. The ratio of subjects who get normalized blood pressure [ Time Frame: 2weeks, 4weeks and 8weeks from Baseline Visit ]
    The ratio of subjects who get normalized blood pressure

  4. Response Rate [ Time Frame: 2weeks, 4weeks and 8weeks from Baseline Visit ]
    Response Rate


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  1. Difference of SiSBP ≥ 20 mmHg and SiDBP ≥ 10 mmHg in 3 blood pressure measurements in the selected reference arm at the screening visit
  2. Blood pressure results showing sitDBP ≥ 120 mmHg at screening and baseline visit(Visit 1; Both Arm, Visit 2: Selected Arm)
  3. Treatment Compliance of Fimasartan/Amlodipine 30/5mg < 70%
  4. Heart failure(New York Heart Association class 3 and 4), ischemic heart disease, peripheral vascular disease
  5. Percutaneous Coronary Artery within 6 months prior to study
  6. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter; or other arrhythmia conditions that are determined to be clinically significant by the investigator
  7. Patients who have history of severe cerebrovascular disease within 6 months prior to study
  8. Type I Diabetes Mellitus or Uncontrolled Type II Diabetes Mellitus(HbA1c > 9% at screening visit
  9. Patients who have history of severe or malignant retinopathy within 6 months prior to study
  10. Pregnant or lactating women
  11. Planning pregnancy during the study period or have childbearing potential but are not using acceptable contraceptive methods
  12. Patients taking other clinical trial drugs within 4 weeks from the time of visit for screening
  13. Patients who are judged unsuitable to participate in this study by investigator
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Bong-Seog KIM 82-2-708-8024 seog9270@boryung.co.kr

Locations
Layout table for location information
Korea, Republic of
Boryung Pharmaceutical Co., Ltd Recruiting
Seoul, Korea, Republic of
Contact: HWA-YEON SHIN    82-2-708-8069    hshin@boryung.co.kr   
Sponsors and Collaborators
Boryung Pharmaceutical Co., Ltd
Tracking Information
First Submitted Date  ICMJE June 17, 2019
First Posted Date  ICMJE June 19, 2019
Last Update Posted Date April 8, 2020
Actual Study Start Date  ICMJE June 17, 2019
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 17, 2019) 		sitting systolic blood pressure [ Time Frame: 8weeks from Baseline Visit ]
The change of sitting systolic blood pressure
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 6, 2020)
  • sitting systolic blood pressure [ Time Frame: 2weeks and 4weeks from Baseline Visit ]
    The change of sitting systolic blood pressure
  • sitting systolic blood pressure and sitting diastolic blood pressure [ Time Frame: 2weeks, 4weeks and 8weeks from Baseline Visit ]
    The change of sitting systolic blood pressure and sitting diastolic blood pressure
  • The ratio of subjects who get normalized blood pressure [ Time Frame: 2weeks, 4weeks and 8weeks from Baseline Visit ]
    The ratio of subjects who get normalized blood pressure
  • Response Rate [ Time Frame: 2weeks, 4weeks and 8weeks from Baseline Visit ]
    Response Rate
Original Secondary Outcome Measures  ICMJE
 (submitted: June 17, 2019)
  • sitting systolic blood pressure [ Time Frame: 2weeks from Baseline Visit ]
    The change of sitting systolic blood pressure
  • sitting systolic blood pressure and sitting diastolic blood pressure [ Time Frame: 2weeks and 8weeks from Baseline Visit ]
    The change of sitting systolic blood pressure and sitting diastolic blood pressure
  • The ratio of subjects who get normalized blood pressure [ Time Frame: 2weeks and 8weeks from Baseline Visit ]
    The ratio of subjects who get normalized blood pressure
  • Response Rate [ Time Frame: 2weeks and 8weeks from Baseline Visit ]
    Response Rate
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BR1010 in Patients With Essential Hypertension Patients Who do Not Adequately Respond to Fimasartan/Amlodipine Combination
Official Title  ICMJE 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
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
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Essential Hypertension
Intervention  ICMJE Drug: Fimasartan/Amlodipine
Active Comparator: a fixed dose combination of Fimasartan/Amlodipine or placebo
Other Name: BR1010 or placebo
Study Arms  ICMJE
  • Experimental: BR1010 and Fimasartan/Amlodipine placebo
    BR1010 or Fimasartan/Amlodipine
    Intervention: Drug: Fimasartan/Amlodipine
  • Active Comparator: BR1010 placebo and Fimasartan/Amlodipine
    BR1010 or Fimasartan/Amlodipine
    Intervention: Drug: Fimasartan/Amlodipine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 17, 2019) 		250
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 1, 2021
Estimated Primary Completion Date September 1, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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:

  1. Difference of SiSBP ≥ 20 mmHg and SiDBP ≥ 10 mmHg in 3 blood pressure measurements in the selected reference arm at the screening visit
  2. Blood pressure results showing sitDBP ≥ 120 mmHg at screening and baseline visit(Visit 1; Both Arm, Visit 2: Selected Arm)
  3. Treatment Compliance of Fimasartan/Amlodipine 30/5mg < 70%
  4. Heart failure(New York Heart Association class 3 and 4), ischemic heart disease, peripheral vascular disease
  5. Percutaneous Coronary Artery within 6 months prior to study
  6. Clinically significant ventricular tachycardia, atrial fibrillation, atrial flutter; or other arrhythmia conditions that are determined to be clinically significant by the investigator
  7. Patients who have history of severe cerebrovascular disease within 6 months prior to study
  8. Type I Diabetes Mellitus or Uncontrolled Type II Diabetes Mellitus(HbA1c > 9% at screening visit
  9. Patients who have history of severe or malignant retinopathy within 6 months prior to study
  10. Pregnant or lactating women
  11. Planning pregnancy during the study period or have childbearing potential but are not using acceptable contraceptive methods
  12. Patients taking other clinical trial drugs within 4 weeks from the time of visit for screening
  13. Patients who are judged unsuitable to participate in this study by investigator
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Bong-Seog KIM 82-2-708-8024 seog9270@boryung.co.kr
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03991442
Other Study ID Numbers  ICMJE BR-FAHC-CT-301
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Boryung Pharmaceutical Co., Ltd
Study Sponsor  ICMJE Boryung Pharmaceutical Co., Ltd
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Boryung Pharmaceutical Co., Ltd
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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