NCT00926289已完成4 期
A Randomised, Double-blind, Double Dummy, Active Controlled, Parallel Group, Forced Titration Study to Compare the Fixed-dose Combination of Telmisartan 80mg Plus Hydrochlorothiazide 25mg (T80/HCTZ25) Versus Telmisartan 80mg (T80) Monotherapy as First Line Therapy in Patients With Grade 2 or Grade 3 Hypertension (Systolic Blood Pressure (SBP) >=160 mmHg and Diastolic Blood Pressure (DBP) >=100 mmHg)
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 894
- 试验地点
- 106
- 主要终点
- Change From Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) to Week 7
研究概览
简要总结
The primary objective of this trial is to demonstrate that the fixed-dose combination of T80/HCTZ25 is superior as first line therapy in reducing seated trough cuff Systolic Blood Pressure(SBP) compared to the monotherapy of T80 in patients with grade 2 or grade 3 hypertension (SBP>=160 mmHg and Diastolic Blood Pressure(DBP)>=100 mmHg).
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
Active Comparator
Telmisartan 80 mg
干预措施: Telmisartan (Drug)
Telmisartan/hydrochlorothiazide
Experimental
Telmisartan80mg/Hydrochlorothiazide25mg
干预措施: Telmisartan (Drug)
Telmisartan/hydrochlorothiazide
Experimental
Telmisartan80mg/Hydrochlorothiazide25mg
干预措施: Hydrochlorothiazide (Drug)
结局指标
主要结局
Change From Baseline in Mean Seated Trough Cuff Systolic Blood Pressure (SBP) to Week 7
时间窗: Baseline and Week 7
The SBP value at baseline was subtracted from the SBP value at Week 7.
次要结局
- Change From Baseline in Mean Seated Trough Cuff SBP to Week 5(Baseline and Week 5)
- Change From Baseline in Mean Seated Trough Cuff SBP to Week 3(Baseline and Week 3)
- Change From Baseline in Mean Seated Trough Cuff Diastolic Blood Pressure (DBP) to Week 7(Baseline and Week 7)
- Number of Patients With SBP Control (SBP < 140 mmHg) at Week 7(Week 7 timepoint)
- Number of Patients With SBP Control (SBP < 140 mmHg) at Week 5(Week 5 timepoint)
- Number of Patients With SBP Control (SBP < 140 mmHg) at Week 3(Week 3 timepoint)
- Number of Patients With DBP Control (DBP < 90 mmHg) at Week 7(Week 7 timepoint)
- Number of Patients With DBP Control (DBP < 90 mmHg) at Week 5(Week 5 timepoint)
- Number of Patients With DBP Control (DBP < 90 mmHg) at Week 3(Week 3 timepoint)
- Number of Patients With Blood Pressure (BP) Control at Week 7(Week 7 timepoint)
- Number of Patients With BP Control at Week 7(Week 7 timepoint)
- Number of Patients With Systolic Blood Pressure (SBP) Response at Week 7(Week 7 timepoint)
- Number of Participants With DBP Response at Week 7(Week 7 timepoint)
- BP Categories at Week 7(Week 7 timepoint)
研究者
研究点 (106)
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