A Randomized, Multi-center, Double-Blind, Controlled, Parallel Design, Phase II Study to Evaluate the Efficacy and Safety Administration by Doses of BR1400-1, BR1400-2, BR1400-3, BR1400-4, and BR1400-5 in Patients With Essential Hypertension
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Change from baseline to treatment of 8 weeks in MSSBP
研究概览
简要总结
The objective of this clinical trial is to evaluate the antihypertensive efficacy and safety of BR1400-1, BR1400-2, BR1400-3, BR1400-4, and BR1400-5 with essential hypertension.
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
- Double (Participant, 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
- •<Screening Visit (V1)>
- •Patients with essential hypertension whose mean sitting systolic blood pressure (MSSBP) measured in the reference arm at the screening (Visit 1) meets the following criteria:
- •For patients not currently receiving antihypertensive therapy: 140 mmHg ≤ MSSBP < 180 mmHg
- •For patients receiving antihypertensive therapy : 130 mmHg ≤ MSSBP < 180 mmHg
- •For patients receiving antihypertensive therapy at the screening (Visit 1), those for whom the investigator determines that it is medically appropriate to temporarily discontinue their current antihypertensive treatment during the study.
- •<Baseline Visit (V2)>
- •Patients with essential hypertension whose mean sitting systolic blood pressure (MSSBP) measured in the reference arm at the baseline (Visit 2) prior to randomization meets the following criteria:
- •For patients without cardiovascular disease: 140 mmHg ≤ MSSBP < 180 mmHg
- •For patients with cardiovascular disease, diabetes with cardiovascular disease, albuminuria, or diabetes with chronic kidney disease (CKD): 130 mmHg ≤ MSSBP < 180 mmHg
排除标准
- •Patients with blood pressure results showing MSSBP ≥ 180 mmHg or MSDBP ≥ 110 mmHg at screening(V1) and baseline(V2)
- •Patients with a history of secondary hypertension or suspected secondary hypertension; (e.g., coarctation of the aorta, hyperaldosteronism, renal artery stenosis, renal hypertension, pheochromocytoma, Cushing's syndrome and polycystic kidney disease, etc.)
- •Patients with shock
- •Patients with orthostatic hypotension accompanied by symptoms
研究组 & 干预措施
BR1400-3 + BR1400-B + BR1400-C
Patients will receive BR1400-3 + BR1400-B (Placebo of BR1400-2 & BR1400-4) + BR1400-C (Placebo of BR1400-5)
干预措施: BR1400-3 (Drug)
BR1400-1 + BR1400-B + BR1400-C
Patients will receive tablet BR1400-1 + BR1400-B (Placebo of BR1400-2 & BR1400-4)+ BR1400-C (Placebo of BR1400-5)
干预措施: BR1400-1 (Drug)
BR1400-1 + BR1400-B + BR1400-C
Patients will receive tablet BR1400-1 + BR1400-B (Placebo of BR1400-2 & BR1400-4)+ BR1400-C (Placebo of BR1400-5)
干预措施: BR1400-B (Drug)
BR1400-1 + BR1400-B + BR1400-C
Patients will receive tablet BR1400-1 + BR1400-B (Placebo of BR1400-2 & BR1400-4)+ BR1400-C (Placebo of BR1400-5)
干预措施: BR1400-C (Drug)
BR1400-A + BR1400-2 + BR1400-C
Patients will receive BR1400-A (Placebo of BR1400-1 & BR1400-3) + BR1400-2 + BR1400-C (Placebo of BR1400-5)
干预措施: BR1400-2 (Drug)
BR1400-A + BR1400-2 + BR1400-C
Patients will receive BR1400-A (Placebo of BR1400-1 & BR1400-3) + BR1400-2 + BR1400-C (Placebo of BR1400-5)
干预措施: BR1400-A (Drug)
BR1400-A + BR1400-2 + BR1400-C
Patients will receive BR1400-A (Placebo of BR1400-1 & BR1400-3) + BR1400-2 + BR1400-C (Placebo of BR1400-5)
干预措施: BR1400-C (Drug)
BR1400-3 + BR1400-B + BR1400-C
Patients will receive BR1400-3 + BR1400-B (Placebo of BR1400-2 & BR1400-4) + BR1400-C (Placebo of BR1400-5)
干预措施: BR1400-B (Drug)
BR1400-3 + BR1400-B + BR1400-C
Patients will receive BR1400-3 + BR1400-B (Placebo of BR1400-2 & BR1400-4) + BR1400-C (Placebo of BR1400-5)
干预措施: BR1400-C (Drug)
BR1400-A + BR1400-4 + BR1400-C
Patients will receive BR1400-A (Placebo of BR1400-1 & BR1400-3) + BR1400-4 + BR1400-C (Placebo of BR1400-5)
干预措施: BR1400-4 (Drug)
BR1400-A + BR1400-4 + BR1400-C
Patients will receive BR1400-A (Placebo of BR1400-1 & BR1400-3) + BR1400-4 + BR1400-C (Placebo of BR1400-5)
干预措施: BR1400-A (Drug)
BR1400-A + BR1400-4 + BR1400-C
Patients will receive BR1400-A (Placebo of BR1400-1 & BR1400-3) + BR1400-4 + BR1400-C (Placebo of BR1400-5)
干预措施: BR1400-C (Drug)
BR1400-A + BR1400-B + BR1400-5
Patients will receive BR1400-A (Placebo of BR1400-1 & BR1400-3) + BR1400-B (Placebo of BR1400-2 & BR1400-4) + BR1400-5
干预措施: BR1400-5 (Drug)
BR1400-A + BR1400-B + BR1400-5
Patients will receive BR1400-A (Placebo of BR1400-1 & BR1400-3) + BR1400-B (Placebo of BR1400-2 & BR1400-4) + BR1400-5
干预措施: BR1400-A (Drug)
BR1400-A + BR1400-B + BR1400-5
Patients will receive BR1400-A (Placebo of BR1400-1 & BR1400-3) + BR1400-B (Placebo of BR1400-2 & BR1400-4) + BR1400-5
干预措施: BR1400-B (Drug)
BR1400-A + BR1400-B + BR1400-C
Patients will receive BR1400-A (Placebo of BR1400-1 & BR1400-3) + BR1400-B (Placebo of BR1400-2 & BR1400-4) + BR1400-C (Placebo of BR1400-5)
干预措施: BR1400-A (Drug)
BR1400-A + BR1400-B + BR1400-C
Patients will receive BR1400-A (Placebo of BR1400-1 & BR1400-3) + BR1400-B (Placebo of BR1400-2 & BR1400-4) + BR1400-C (Placebo of BR1400-5)
干预措施: BR1400-B (Drug)
BR1400-A + BR1400-B + BR1400-C
Patients will receive BR1400-A (Placebo of BR1400-1 & BR1400-3) + BR1400-B (Placebo of BR1400-2 & BR1400-4) + BR1400-C (Placebo of BR1400-5)
干预措施: BR1400-C (Drug)
结局指标
主要结局
Change from baseline to treatment of 8 weeks in MSSBP
时间窗: 8 weeks
次要结局
未报告次要终点