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Completed

NCT Number: NCT03991442

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

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

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Boryung Pharmaceutical Co., Ltd

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fimasartan/Amlodipine

Drug

Active Comparator: a fixed dose combination of Fimasartan/Amlodipine or placebo

Other names: BR1010 or placebo

Primary outcomes

  1. sitting systolic blood pressure

    Time frame: 8weeks from Baseline Visit

    The change of sitting systolic blood pressure

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Boryung Pharmaceutical Co., Ltd

Industry

Registry information

Official study 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

Acronym: FINAL

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Jun 19, 2019
Registry last updated
Jul 30, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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