NCT03991442已完成3 期
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
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 257
- 试验地点
- 1
- 主要终点
- sitting systolic blood pressure
研究概览
简要总结
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
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
BR1010 placebo and Fimasartan/Amlodipine
Active Comparator
BR1010 or Fimasartan/Amlodipine
干预措施: Fimasartan/Amlodipine (Drug)
BR1010 and Fimasartan/Amlodipine placebo
Experimental
BR1010 or Fimasartan/Amlodipine
干预措施: Fimasartan/Amlodipine (Drug)
结局指标
主要结局
sitting systolic blood pressure
时间窗: 8weeks from Baseline Visit
The change of sitting systolic blood pressure
次要结局
- sitting systolic blood pressure(2weeks and 4weeks from Baseline Visit)
- sitting systolic blood pressure and sitting diastolic blood pressure(2weeks, 4weeks and 8weeks from Baseline Visit)
- The ratio of subjects who get normalized blood pressure(2weeks, 4weeks and 8weeks from Baseline Visit)
- Response Rate(2weeks, 4weeks and 8weeks from Baseline Visit)
研究者
研究点 (1)
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