A Randomized, Double-blind, Active-controlled, Multicenter Phase 3 Trial to Evaluate the Safety and Efficacy of YH22162 in Subjects With Essential Hypertension Inappropriately Controlled on Telmisartan/Amlodipine Treatment
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 381
- 试验地点
- 1
- 主要终点
- Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8
研究概览
简要总结
To evaluate efficacy and safety of YH22162 versus telmisartan / amlodipine treatment in patients with hypertension inappropriately controlled on telmisartan/amlodipine treatment
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
- •Signed Informed Consent
- •Men and women ≥ 19 years of age
- •Essential hypertensive patients
- •If already taking antihypertensive drugs, mean sitting systolic blood pressure (MSSBP) must be 140 mmHg ≤ MSSBP < 200 mmHg
- •If not taking any antihypertensive drugs at least 4 weeks, mean sitting systolic blood pressure (MSSBP) must be 160 mmHg ≤ MSSBP < 200 mmHg
排除标准
- •Patients with known or suspected secondary hypertension
- •Other exclusions applied
研究组 & 干预措施
YH22162
YH22162 40/5/12.5 mg (telmisartan 40/amlodipine 5mg/chlorthalidone 12.5mg) for the first 2 weeks, then force titrated to YH22162(telmisartan 80mg/amlodipine 5mg/chlorthalidone 25mg) for the remaining 6weeks
干预措施: YH22162 40/5/12.5 mg (Drug)
YH22162
YH22162 40/5/12.5 mg (telmisartan 40/amlodipine 5mg/chlorthalidone 12.5mg) for the first 2 weeks, then force titrated to YH22162(telmisartan 80mg/amlodipine 5mg/chlorthalidone 25mg) for the remaining 6weeks
干预措施: YH22162 80/5/25 mg (Drug)
YH22162
YH22162 40/5/12.5 mg (telmisartan 40/amlodipine 5mg/chlorthalidone 12.5mg) for the first 2 weeks, then force titrated to YH22162(telmisartan 80mg/amlodipine 5mg/chlorthalidone 25mg) for the remaining 6weeks
干预措施: telmisartan/amlodipine 40/5mg placebo (Drug)
YH22162
YH22162 40/5/12.5 mg (telmisartan 40/amlodipine 5mg/chlorthalidone 12.5mg) for the first 2 weeks, then force titrated to YH22162(telmisartan 80mg/amlodipine 5mg/chlorthalidone 25mg) for the remaining 6weeks
干预措施: telmisartan/amlodipine 80/5mg placebo (Drug)
telmisartan/amlodipine
Twynsta(telmisartan 40/amlodipine 5mg) for the first 2 weeks, then force titrated to Twynsta(telmisartan 80mg/amlodipine 5mg) for the remaining 6weeks
干预措施: telmisartan/amlodipine 40/5mg (Drug)
telmisartan/amlodipine
Twynsta(telmisartan 40/amlodipine 5mg) for the first 2 weeks, then force titrated to Twynsta(telmisartan 80mg/amlodipine 5mg) for the remaining 6weeks
干预措施: telmisartan/amlodipine 80/5mg (Drug)
telmisartan/amlodipine
Twynsta(telmisartan 40/amlodipine 5mg) for the first 2 weeks, then force titrated to Twynsta(telmisartan 80mg/amlodipine 5mg) for the remaining 6weeks
干预措施: YH22162 40/5/12.5 mg placebo (Drug)
telmisartan/amlodipine
Twynsta(telmisartan 40/amlodipine 5mg) for the first 2 weeks, then force titrated to Twynsta(telmisartan 80mg/amlodipine 5mg) for the remaining 6weeks
干预措施: YH22162 80/5/25 mg placebo (Drug)
结局指标
主要结局
Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 8
时间窗: baseline and week 8
次要结局
- Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 4(baseline and week 4)
- Change From Baseline in Mean Sitting Systolic Blood Pressure (MSSBP) at Week 2(baseline and week 2)
- Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSSBP) at Week 8(baseline and week 8)
- Patients Achieving Blood Pressure Control at Week 4(baseline and week 4)
- Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSSBP) at Week 2(baseline and week 2)
- Patients Achieving Blood Pressure Control at Week 8(baseline and week 8)
- Reduction From Baseline in Mean Sitting Blood Pressure (MSBP) at Week 4(baseline and week 4)
- Change From Baseline in Mean Sitting Diastolic Blood Pressure (MSSBP) at Week 4(baseline and week 4)
- Patients Achieving Blood Pressure Control at Week 2(baseline and week 2)
- Reduction From Baseline in Mean Sitting Blood Pressure (MSBP) at Week 8(baseline and week 8)
- Reduction From Baseline in Mean Sitting Blood Pressure (MSBP) at Week 2(baseline and week 2)