A 12-week Multicenter, Randomized, Double-blind, Parallel-group, Active-control Study to Evaluate the Antihypertensive Efficacy and Safety of Valsartan/Amlodipine-based Regimen Versus a Losartan-based Regimen in Patients With Stage 2 Systolic Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 488
- 试验地点
- 1
- 主要终点
- Change in Mean Sitting Systolic Blood Pressure After 6 Weeks
研究概览
简要总结
This study will compare the antihypertensive efficacy and safety of a valsartan/amlodipine-based treatment with a losartan-based treatment in patients with Stage 2 systolic hypertension (high blood pressure, mean systolic blood pressure greater than 160 and less than 200 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 (Participant, 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 or female outpatient of 18 years of age or greater
- •Stage 2 systolic hypertension defined as office Mean Sitting Systolic blood pressure (MSSBP) greater than or equal to 160 and < 200 mmHg at randomization
- •Patients who were able to participate in the study, and who gave written informed consent before any study assessment was performed.
排除标准
- •Office systolic blood pressure >200 and/or mean sitting diastolic blood pressure (MSDBP) greater than or equal to 110 mmHg at Visit
- •Use of four (4) or more antihypertensive medications within 30 days of Visit
- •Refractory hypertension, defined as blood pressure >140/90 mmHg while taking three (3) drugs at the maximum dose of each drug, one of which must be a diuretic. (Therapy with a fixed-dose combination of two active medications represents two drugs).
- •Inability to safely discontinue all antihypertensive medications for 1-2 weeks prior to randomization.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Valsartan/amlodipine/HCTZ
Valsartan/amlodipine-based regimen: at randomization (Visit 3) patients were treated with valsartan/amlodipine 160/5 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks, and a second forced titration at Visit 5 (Week 6) to valsartan/amlodipine/HCTZ 320/10/25 mg for the remaining 6 weeks of the study.
干预措施: valsartan, amlodipine, HCTZ (Drug)
Losartan/HCTZ
Losartan-based regimen: at randomization (Visit 3) patients were treated with losartan 100 mg for 3 weeks, followed by a forced titration at Visit 4 (Week 3) to losartan/HCTZ 100/25 mg. At Visit 5 (Week 6) patients were switched to valsartan/amlodipine/HCTZ 160/5/25 mg for 3 weeks and, at Visit 6 (Week 9), patients were force titrated to valsartan/amlodipine/HCTZ 320/10/25 mg for the final 3 weeks of the study.
干预措施: Losartan, HCTZ followed by valsartan, amlodipine, HCTZ (Drug)
结局指标
主要结局
Change in Mean Sitting Systolic Blood Pressure After 6 Weeks
时间窗: Baseline to Week 6
To compare the change from baseline in mean sitting systolic blood pressure (MSSBP) after 6 weeks of valsartan/amlodipine-based regimen with a losartan-based regimen in patients with Stage 2 systolic hypertension.
次要结局
- Change in Mean Sitting Diastolic Blood Pressure After 6 Weeks(Baseline to Week 6)
- Cumulative Percentage of Patients Achieving Blood Pressure Control(3 and 6 weeks)
- Cumulative Percentage of Treatment Responders(3 and 6 weeks)
- Change in Mean Sitting Systolic and Diastolic Blood Pressure After 12 Weeks(Baseline to week 12)
- Cumulative Percentage of Patients With Incidence of Peripheral Edema Before or at the Corresponding Visit(3, 6, 9 and 12 weeks)