NCT05878561已完成3 期
A Randomized, Double-blind, Multicenter, Phase III Study to Evaluate the Efficacy and Safety of BR1015 Combination Therapy in Comparison With Fimasartan Monotherapy for Essential Hypertension Patients Not Adequately Responded by Fimasartan 30 mg
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
- 248
- 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 trial is to evaluate the efficacy and safety of BR1015 Combination therapy group in comparison with Fimasartan monotherapy group at Week 8 for essential hypertension patients who do not adequately responded by Fimasartan 30 mg
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
- •Patients with uncontrolled essential hypertension at screening(V1) under the following criteria:
- •Naïve : 140 mmHg ≤ SiSBP < 180 mmHg
- •Use antihypertensive drugs : 130 mmHg ≤ SiSBP < 180 mmHg
- •Patients with uncontrolled essential hypertension at randomization(V2) after Fimasartan 30mg monotherapy for 4 weeks under the following criteria:
- •Selected reference arm : 140 mmHg ≤ SiSBP < 180 mmHg (For patients with cardiovascular disease, diabetes or chronic kidney disease (CKD) with albuminuria, 130 mmHg ≤ SiSBP < 180 mmHg)
- •Treatment compliance of Fimasartan 30 mg ≥70% at baseline visit (V2)
- •Voluntarily provided a written consent to participate in this clinical study
- •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
- •Patients taking three or more antihypertensive drugs of different families
- •Patients with blood pressure results showing SiSBP ≥ 180 mmHg or SiDBP ≥ 110 mmHg in the selected reference arm at screening(V1) and randomization(V2)
- •Patients with a difference of SiSBP ≥ 20 mmHg and SiDBP ≥ 10 mmHg in blood pressure measured three times on both arms at screening(V1)
- •Patients with secondary hypertension: Secondary hypertension is not limited to the following diseases; (e.g., coarctation of the aorta, Primary hyperaldosteronism, renal artery stenosis, Cushing's syndrome, pheochromocytoma and polycystic kidney disease, etc.)
- •Patients with orthostatic hypotension accompanied by symptoms
- •Patients who need to be administered in combination with antihypertensive drugs other than investigational product while participating in clinical trials
研究组 & 干预措施
Fimasartan + Indapamide
Experimental
Treatment Period I, II
干预措施: Fimasartan + Indapamide (Drug)
Fimasartan + Indapamide placebo
Active Comparator
Treatment Period I, II
干预措施: Fimasartan + Indapamide placebo (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(4weeks from Baseline Visit)
研究者
研究点 (1)
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