An Open-Label, Superiority, Randomized, Comparative Study to Evaluate the Efficacy and Safety of Telmisartan, Amlodipine, and Chlorthalidone Fixed-Dose Combination Versus Telmisartan, Amlodipine, and Hydrochlorothiazide in Elderly Patients With Essential Hypertension Uncontrolled by Telmisartan and Amlodipine Combinations
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 198
- 试验地点
- 15
- 主要终点
- Mean Systolic Blood Pressure (MSBP) in nighttime
研究概览
简要总结
This study is to compare the efficacy and safety of Telmisartan, Amlodipine, and Chlorthalidone Fixed-Dose Combination and Telmisartan, Amlodipine, and Hydrochlorothiazide in Elderly Patients with Essential Hypertension Uncontrolled by Telmisartan and Amlodipine Combinations
详细描述
This is a Phase IV, Randomized, Open-label, Superiority, Comparative study evaluating the efficacy and safety of Telmisartan, Amlodipine, and Chlorthalidone Fixed-Dose Combination) versus Telmisartan, Amlodipine, and Hydrochlorothiazide in eledrly patient with essential hypertension uncontrolled by Telmisartan and Amlodipine Combinations.
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
- None
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who have been fully informed about the purpose, content, and characteristics of investigational product, and have voluntarily agreed in writing
- •Aged ≥ 65 with essential hypertension
- •Patient with uncontrolled essential hypertension at screening
- •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
- •Patient who has history of drug allergic reactions
- •Known hypersensitivity to components of the investigational product
- •Patient who is unable to stop taking prohibited drugs
- •Test results showing the following values at screening
- •The change of MSSBP ≥ 20 mmHg and MSDBP ≥ 10 mmHg on target arm between 1st and 2nd measurements
- •Pregnant or lactating women
- •Patient who is unable to maintain proper night sleep
- •Malnutrition, starvation, debilitating factors, A person who is being forcibly detained for the treatment of mental or physical
- •Administration of other investigational products within 3 months prior to screening.
- •An impossible one who participates in clinical trial by investigator's decision
研究组 & 干预措施
Telmisartan/Amlodipine/Chlorthalidonea 40/5/12.5 mg
Telmisartan/Amlodipine/Chlorthalidonea 40/5/12.5 mg will be orally administered during the study period
干预措施: Telmisartan/Amlodipine/Chlorthalidone 40/5/12.5 mg (Drug)
Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg
Telmisartan/Amlodipine 40/5 mg and Hydrochlorothiazide 25 mg will be orally administered each during study period
干预措施: Telmisartan/Amlodipine/Hydrochlorothiazide 40/5/25 mg (Drug)
结局指标
主要结局
Mean Systolic Blood Pressure (MSBP) in nighttime
时间窗: Week 8
To evaluate change from baseline in nighttime Mean Systolic Blood Pressure (MSBP) measured by Ambulatory Blood Pressure Monitoring at Week 8
次要结局
- Mean Systolic Blood Pressure (MSBP)/Mean Diastolic Blood Pressure (MDBP) in daytime(Week 8 and Week 26 if applicable)
- Mean Systolic Blood Pressure (MSBP) in nighttime(Week 26 if applicable)
- Mean Diastolic Blood Pressure (MDBP) in nighttime(Week 8 and Week 26 if applicable)
- Patients Achieving in nighttime Mean Systolic Blood Pressure (MSBP)(Week 8)
- Percentage of patients with decreased Mean Sitting Systolic Blood Pressure (MSSBP) and Mean Sitting Diastolic Blood Pressure (MSDBP).(Week 4, Week 8 and Week 26 if applicable)
- Mean Sitting Systolic Blood Pressure (MSSBP)/ Mean Sitting Diastolic Blood Pressure (MSDBP)(Week 4, Week 8 and Week 26 if applicable)
- T/P ratio(Week 8 and Week 26 if applicable)
- 24-hour Mean Systolic Blood Pressure (MSBP)/Mean Diastolic Blood Pressure (MDBP)(Week 8 and Week 26 if applicable)
- Patients Achieving in Mean Sitting Systolic Blood Pressure (MSSBP)(Week 4, Week 8 and Week 26 if applicable)