NCT00877929已完成3 期
An 8-week Randomised, Double-blind Study to Compare the Fixed-dose Combination of Telmisartan 80 + Amlodipine 10mg Versus Amlodipine 10 mg Monotherapy as First Line Therapy in Type 2 Diabetes Patients With Hypertension.
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
- 706
- 试验地点
- 65
- 主要终点
- Change From Baseline in Trough Seated Systolic Blood Pressure to Week 8
研究概览
简要总结
To demonstrate that the fixed dose combination of telmisartan and amlodipine is more effective in lowering blood pressure.
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 80 / Amlodipine 10
Experimental
Telmisartan 80 / Amlodipine 5 for two weeks, then forced titration to Telmisartan 80 / Amlodipine 10 Fixed Dose Combination
干预措施: Telmisartan 80 (Drug)
Amlodipine 10
Active Comparator
Amlodipine 5 for two weeks, then forced titration to Amlodipine 10
干预措施: Amlodipine 10 (Drug)
Telmisartan 80 / Amlodipine 10
Experimental
Telmisartan 80 / Amlodipine 5 for two weeks, then forced titration to Telmisartan 80 / Amlodipine 10 Fixed Dose Combination
干预措施: Amlodipine 10 (Drug)
结局指标
主要结局
Change From Baseline in Trough Seated Systolic Blood Pressure to Week 8
时间窗: Baseline, week 8
Trough blood pressure measurements were the measurements observed at the end of the dosing interval just prior to the next dose of medication.
次要结局
- Change From Baseline in Trough Seated Systolic Blood Pressure to Week 6(Baseline, week 6)
- Change From Baseline in Trough Seated Systolic Blood Pressure to Week 4(Baseline, week 4)
- Change From Baseline in Trough Seated Systolic Blood Pressure to Week 2(Baseline, week 2)
- Change From Baseline in Trough Seated Systolic Blood Pressure to Week 1(Baseline, week 1)
- Blood Pressure (BP) Control (SBP<140 mmHg, DBP<90 mmHg) at Eight Weeks(Baseline, week 8)
- BP Control (SBP<140 mmHg, DBP<90 mmHg) at Six Weeks(Baseline, week 6)
- BP Control (SBP<140 mmHg, DBP<90 mmHg) at Four Weeks(Baseline, week 4)
- BP Control (SBP<140 mmHg, DBP<90 mmHg) at Two Weeks(Baseline, week 2)
- BP Control (SBP<140 mmHg, DBP<90 mmHg) at One Week(Baseline, week 1)
- BP Control (SBP<130 mmHg, DBP<80 mmHg) at Eight Weeks(Baseline, week 8)
- BP Control (SBP<130 mmHg, DBP<80 mmHg) at Six Weeks(Baseline, week 6)
- BP Control (SBP<130 mmHg, DBP<80 mmHg) at Four Weeks(Baseline, week 4)
- BP Control (SBP<130 mmHg, DBP<80 mmHg) at Two Weeks(Baseline, week 2)
- BP Control (SBP<130 mmHg, DBP<80 mmHg) at One Week(Baseline, week 1)
- Systolic Blood Pressure (SBP) Control 140 at Eight Weeks(Baseline, week 8)
- SBP Control 140 at Six Weeks(Baseline, week 6)
- SBP Control 140 at Four Weeks(Baseline, week 4)
- SBP Control 140 at Two Weeks(Baseline, week 2)
- SBP Control 140 at One Week(Baseline, week 1)
- SBP Control 130 at Eight Weeks(Baseline, week 8)
- SBP Control 130 at Six Weeks(Baseline, week 6)
- SBP Control 130 at Four Weeks(Baseline, week 4)
- SBP Control 130 at Two Weeks(Baseline, week 2)
- SBP Control 130 at One Week(Baseline, week 1)
- SBP Response 140 at Eight Weeks(Baseline, week 8)
- SBP Response 140 at Six Weeks(Baseline, week 6)
- SBP Response 140 at Four Weeks(Baseline, week 4)
- SBP Response 140 at Two Weeks(Baseline, week 2)
- SBP Response 140 at One Week(Baseline, week 1)
- SBP Response 130 at Eight Weeks(Baseline, week 8)
- SBP Response 130 at Six Weeks(Baseline, week 6)
- SBP Response 130 at Four Weeks(Baseline, week 4)
- SBP Response 130 at Two Weeks(Baseline, week 2)
- SBP Response 130 at One Week(Baseline, week 1)
- DBP Response at Eight Weeks(Week 8)
- DBP Response at Six Weeks(week 6)
- DBP Response at Week Four(Week 4)
- DBP Response at Week Two(Week 2)
- DBP Response at Week One(Week 1)
- Change From Baseline in Urine Albumin:Creatinine Ratio (UACR)(8 weeks)
研究者
研究点 (65)
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