A Multicenter, Randomized, Double Blind, Parallel Design Trial to Evaluate the Blood Pressure Lowering Efficacy Comparing Moderate Versus Aggressive Treatment Regimen of Valsartan + Amlodipine in Patients Uncontrolled on ARB Monotherapy
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 728
- 试验地点
- 1
- 主要终点
- Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP)
研究概览
简要总结
The purpose of this trial is to compare blood pressure lowering efficacy of moderate Valsartan + Amlodipine treatment regimen (160 / 5 mg) with that of aggressive regimen (320 / 10 mg) in patients uncontrolled on ARB monotherapy, other than Valsartan
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
- Triple (Participant, Care Provider, Investigator)
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 and female outpatients
- •18 Years of age or older
- •Mean Sitting Systolic Blood Pressure (the top number) greater than or equal to 150 mmHg and lower than 200 mmHg while on Angiotensin-Receptor Blocker monotherapy for a minimum period of 28 days prior to randomization
排除标准
- •Mean Sitting Systolic Blood Pressure (the top number) greater than or equal to 200 mmHg and/or Mean Sitting Diastolic Blood Pressure greater than or equal to 120 mmHg
- •Transient ischemic attack (mini-stroke), myocardial infarction (heart attack), all types of revascularization procedures in the last 6 months
- •Treatment with valsartan or any combination antihypertensive treatment with 28 days prior to screening (Visit 1)
研究组 & 干预措施
Aggressive treatment regimen (5/320 mg to 10/320 mg)
Valsartan + Amlodipine, daily: 320 mg + 5 mg (2 weeks); Valsartan + Amlodipine, daily: 320 mg + 10 mg (2 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 320 mg + 10 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
干预措施: valsartan and amlodipine (Drug)
Moderate treatment regimen (5/160 mg)
Valsartan + Amlodipine, daily dose: 160 mg + 5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg (4 weeks); Valsartan + Amlodipine and Hydrochlorothiazide, daily: 160 mg + 5 mg and 12.5 mg or 25 mg (optional titration) (4 weeks)
干预措施: valsartan and amlodipine (Drug)
结局指标
主要结局
Change From Baseline to Week 4 in Mean Sitting Systolic Blood Pressure (MSSBP)
时间窗: Baseline and Week 4
次要结局
- Percentage of Patients Achieving the Blood Pressure (BP) Goal of < 140/90 mmHg at Weeks 2,4,8 and 12(Weeks 2, 4, 8 and 12)
- Percentage of Patients Achieving BP Goal of MSSBP < 140mmHg at Weeks 2, 4, 8 and 12(Weeks 2, 4, 8 and 12)
- Change From Baseline to Week 4 in Mean Sitting Diastolic Blood Pressure (MSDBP)(Baseline and Week 4)
- Change From Baseline to Weeks 2, 8 and 12 in MSDBP(Baseline and Weeks 2, 8 and 12)
- Change From Baseline to Weeks 2, 8 and 12 in MSSBP(Baseline and Weeks 2, 8 and 12)