NCT00860262已完成3 期
An 8-week Randomised, Double-blind Study to Compare the Fixed-dose Combination of Telmisartan 80 mg & Amlodipine 10mg Versus Telmisartan 80 mg Monotherapy or Amlodipine 10 mg Monotherapy as First Line Therapy in Patients With Severe Hypertension (Grade 3).
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
- 858
- 试验地点
- 137
- 主要终点
- Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8
研究概览
简要总结
The primary objective of this trial is to demonstrate that following eight weeks of treatment the FDC of telmisartan 80 mg plus amlodipine 10 mg (T80/A10) is superior as first line therapy in reducing mean seated trough cuff Systolic Blood Pressure [SBP] compared to the monotherapies of telmisartan 80 mg (T80) and amlodipine 10 mg (A10) in patients with severe hypertension. A key secondary objective is to identify the duration of treatment required to demonstrate the superiority of the FDC over both of the monotherapies.
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
telmisartan and amlodipine
Experimental
telmisartan and amlodipine used in combination vs amlodipine or telmisartan
干预措施: telmisartan and amlodipine (Drug)
amlodipine
Active Comparator
telmisartan and amlodipine used in combination vs amlodipine or telmisartan
干预措施: amlodipine (Drug)
telmisartan
Active Comparator
telmisartan and amlodipine used in combination vs amlodipine or telmisartan
干预措施: telmisartan (Drug)
结局指标
主要结局
Change From Baseline in Trough Seated Systolic Blood Pressure (SBP) at Week 8
时间窗: baseline and week 8
Overall mean reduction from a common mean baseline in SBP
次要结局
- Change From Baseline in Trough Seated Systolic Blood Pressure at Week 1(baseline and week 1)
- Change From Baseline in Trough Seated Systolic Blood Pressure at Week 6(baseline and week 6)
- Change From Baseline in Trough Seated Systolic Blood Pressure at Week 4(baseline and week 4)
- Change From Baseline in Trough Seated Systolic Blood Pressure at Week 2(baseline and week 2)
- Change From Baseline in Trough Seated Diastolic Blood Pressure (DBP) at Week 8(baseline and week 8)
- Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 6(baseline and week 6)
- Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 4(baseline and week 4)
- Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 2(baseline and week 2)
- Change From Baseline in Trough Seated Diastolic Blood Pressure at Week 1(baseline and week 1)
- Patients Achieving Diastolic Blood Pressure Control at Week 1(week 1)
- Patients Achieving Diastolic Blood Pressure Control at Week 2(week 2)
- Patients Achieving Blood Pressure Control at Week 1(week 1)
- Patients Achieving Blood Pressure Control at Week 2(week 2)
- Patients Achieving Diastolic Blood Pressure Response at Week 1(baseline, week 1)
- Patients Achieving Diastolic Blood Pressure Response at Week 2(baseline, week 2)
- Patients Achieving Systolic Blood Pressure Response at Week 1(baseline, week 1)
- Patients Achieving Systolic Blood Pressure Response at Week 2(baseline, week 2)
- Number of Patients Achieving Various Blood Pressure Response Levels at Week 1(week 1)
- Number of Patients Achieving Various Blood Pressure Response Levels at Week 2(week 2)
- Patients Achieving Diastolic Blood Pressure Control at Week 4(week 4)
- Patients Achieving Diastolic Blood Pressure Control at Week 6(week 6)
- Patients Achieving Diastolic Blood Pressure Control at Week 8(week 8)
- Patients Achieving Blood Pressure Control at Week 4(week 4)
- Patients Achieving Blood Pressure Control at Week 6(week 6)
- Patients Achieving Blood Pressure Control at Week 8(week 8)
- Patients Achieving Diastolic Blood Pressure Response at Week 4(baseline, week 4)
- Patients Achieving Diastolic Blood Pressure Response at Week 6(baseline, week 6)
- Patients Achieving Diastolic Blood Pressure Response at Week 8(baseline, week 8)
- Patients Achieving Systolic Blood Pressure Response at Week 4(baseline, week 4)
- Patients Achieving Systolic Blood Pressure Response at Week 6(baseline, week 6)
- Patients Achieving Systolic Blood Pressure Response at Week 8(baseline, week 8)
- Patients Achieving Normal Blood Pressure Response at Week 4(week 4)
- Patients Achieving Normal Blood Pressure Response at Week 6(week 6)
- Patients Achieving Normal Blood Pressure Response at Week 8(week 8)
研究者
研究点 (137)
Loading locations...
相似试验
已完成
不适用
The Effects of Bifidobacterium Longum 1714® in a Population With Low MoodLow MoodDepressive SymptomsNCT04925440PrecisionBiotics Group Ltd.168
已完成
3 期
Efficacy Study of Vortioxetine (Lu AA21004) for Treatment of Major Depressive DisorderMajor Depressive DisorderNCT01355081Takeda366
进行中（未招募）
不适用
An Efficacy Trial in the Research Area of Gastrointestinal Health & BloatingGastrointestinal DysfunctionNCT05418127Coconut Goodness Food Products Inc.60
已完成
4 期
Blood Pressure Lowering of Aliskiren HCTZ Compared to HCTZ in Stage 2 Systolic Hypertension in Older PopulationHypertensionNCT00760266Novartis451
已完成
4 期
A Study Evaluating Duloxetine in Patients Hospitalized for Severe DepressionMajor Depressive DisorderNCT00422162Eli Lilly and Company339