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

Sponsor
Boryung Pharmaceutical Co., Ltd (Industry)
Overall Status
Completed
CT.gov ID
NCT03991442
Collaborator
(none)
257
Enrollment
1
Location
2
Arms
20.5
Actual Duration (Months)
12.5
Patients Per Site Per Month

Study Details

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
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
257 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 :
Jun 17, 2019
Actual Primary Completion Date :
Mar 2, 2021
Actual Study Completion Date :
Mar 2, 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 Names:
  • 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 Names:
  • BR1010 or placebo

    		•

    Outcome Measures

    Primary Outcome Measures

    1. sitting systolic blood pressure [8weeks from Baseline Visit]

      The change of sitting systolic blood pressure

    Secondary Outcome Measures

    1. sitting systolic blood pressure [2weeks and 4weeks from Baseline Visit]

      The change of sitting systolic blood pressure

    2. sitting systolic blood pressure and sitting diastolic blood pressure [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 [2weeks, 4weeks and 8weeks from Baseline Visit]

      The ratio of subjects who get normalized blood pressure

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

      Response Rate

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Boryung Pharmaceutical Co., Ltd Seoul Korea, Republic of

    Sponsors and Collaborators

    • Boryung Pharmaceutical Co., Ltd

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Boryung Pharmaceutical Co., Ltd
    ClinicalTrials.gov Identifier:
    NCT03991442
    Other Study ID Numbers:
    • BR-FAHC-CT-301
    First Posted:
    Jun 19, 2019
    Last Update Posted:
    Jul 30, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypertension
    Essential Hypertension
    Amlodipine

    Study Results

    No Results Posted as of Jul 30, 2021