Effect of the Fixed Dose Combination Amlodipine/Valsartan on Central Aortic Blood Pressure in Uncontrolled Essential Hypertension With Amlodipine 5 mg
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 393
- 试验地点
- 1
- 主要终点
- Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 24 (Radial Measurement)
研究概览
简要总结
Assess that for an equivalent brachial blood pressure (BP)lowering, a fixed dose combination amlodipine/valsartan based regimen reduces central aortic BP pressure to a larger extent than an atenolol/amlodipine combination based regimen.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients 18 years of age or older
- •Hypertension defined by MSDBP > 90 and or MSSBP > 140 mmHg, MSDBP > 80 mmHg, or/and MSSBP > 130 mmHg if diabetes or chronic renal impairment uncontrolled under their previous therapy, or untreated , or experiencing unacceptable side effects
- •Written informed consent to participate in the study prior to any study procedures
排除标准
- •Severe hypertension (grade 3 WHO classification MSDBP > 110 mmHg and/or MSSBP > 180 mmHg)
- •Evidence of a secondary form of hypertension
- •Type 1 diabetes mellitus
- •History of congestive heart failure, unstable coronary insufficiency, life threatening arrhythmia, significant valvular disease, second or third degree heart block etc.
研究组 & 干预措施
Valsartan/amlodipine 160/10 mg
Patients were treated with valsartan/amlodipine 80/5 mg for 8 weeks followed by forced uptitration to valsartan/amlodipine 160/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
干预措施: Valsartan/amlodipine 80/5 mg tablets (Drug)
Atenolol/amlodipine 100/10 mg
Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
干预措施: Amlodipine 5 mg capsules (Drug)
Atenolol/amlodipine 100/10 mg
Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
干预措施: Amlodipine 10 mg capsules (Drug)
Atenolol/amlodipine 100/10 mg
Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
干预措施: Atenolol 50 mg tablets (Drug)
Atenolol/amlodipine 100/10 mg
Patients were treated with atenolol/amlodipine 50/5 mg for 8 weeks followed by forced uptitration to atenolol/amlodipine 100/10 mg for 16 weeks. All doses were taken orally once daily in the morning, except on days when clinic visits were scheduled.
干预措施: Atenolol 100 mg tablets (Drug)
结局指标
主要结局
Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 24 (Radial Measurement)
时间窗: Baseline and Week 24
次要结局
- Change From Baseline of Central Systolic Blood Pressure (SBP) at Week 8 (Radial Measurement)(Baseline and Week 8)
- Change From Baseline of Central Pulse Pressure at Week 24 (Radial Measurement)(Baseline and Week 24)
- Change From Baseline of Augmentation Index (Aix) at Week 8(Baseline and Week 8)
- Change From Baseline of Aix at Week 24(Baseline and Week 24)
- Change From Baseline of Aix Corrected to Heart Rate at Week 24(Baseline and Week 24)
- Change From Baseline of Pulse Wave Velocity at Week 24 (Radial Measurement)(Baseline and Week 24)
- Change From Baseline of Brachial SBP/DBP at Week 24 (Tonometry Center)(Baseline and Week 24)
- Change From Baseline of Brachial Pulse Pressure at Week 24 (Tonometry Center)(Baseline and Week 24)
- Change From Baseline of SBP/DBP at Week 24 (Office BP)(Baseline and Week 24)
- Change From Baseline of Pulse Pressure at Week 24 (Office BP)(Baseline and Week 24)