8 Week Randomised Double-blind Study to Compare the Efficacy and Safety of Telmisartan 80mg+ Amlodipine 5 mg vs. Amlodipine 5mg Monotherapy in Patients With Hypertension Who Fail to Respond Adequately to Treatment With Amlodipine 5mg Monotherapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 324
- 试验地点
- 16
- 主要终点
- Change From Baseline in DBP After 8 Weeks of Treatment
研究概览
简要总结
The primary objectives of this trial is to demonstrate that the fixed-dose combination of telmisartan 80mg plus amlodipine 5mg (T80/A5) is superior to amlodipine 5mg (A5) in reducing seated trough diastolic blood pressure (DBP) at 8 weeks.
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Telmisartan80mg+Amlodipine5mg
combination therapy
干预措施: Telmisartan80mg+Amlodipine5mg (Drug)
amlodipine 5 mg
Monotherapy
干预措施: amlodipine 5mg (Drug)
amlodipine 5 mg
Monotherapy
干预措施: Telmisartan80mg+Amlodipine 5mg (Drug)
结局指标
主要结局
Change From Baseline in DBP After 8 Weeks of Treatment
时间窗: Baseline and 8 weeks
Seated trough DBP after 8 weeks or last observation carried forward (LOCF). Analysis will be adjusted for treatment, country, and baseline measurement of endpoint.
Change From Baseline in DBP After 8 Weeks of Treatment in Chinese Patients
时间窗: Baseline and 8 weeks
Seated trough DBP after 8 weeks or LOCF in Chinese patients. Analysis will be adjusted for treatment and baseline measurement of endpoint.
次要结局
- Change From Baseline in SBP After 8 Weeks of Treatment(Baseline and 8 weeks)
- DBP and SBP Control and Response After 8 Weeks of Treatment(Baseline and 8 weeks)
- Number of Patients in Blood Pressure Categories Over Time(8 weeks)
- Change From Baseline in DBP After 4 Weeks of Treatment(Baseline and 4 weeks)
- Change From Baseline in SBP After 4 Weeks of Treatment(Baseline and 4 weeks)
- DBP and SBP Control and Response After 4 Weeks of Treatment(Baseline and 4 weeks)
- Number of Patients in Blood Pressure Categories at 4 Weeks(4 weeks)
- Clinically Relevant Abnormalities for Physical Examination, Pulse Rate, Laboratory Parameters and ECG.(From drug administration until end of treatment plus one day)