A Twenty-four Week, Open-label, Non-comparative, Multi-center Study to Assess the Efficacy and Tolerability of an Aliskiren-based Treatment Algorithm in Patients With Mild to Moderate Hypertension.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 256
- 试验地点
- 1
- 主要终点
- Percentage of Participants (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped Care, Aliskiren-based Regimen
研究概览
简要总结
This study will assess the efficacy of an aliskiren based treatment regimen in reaching blood pressure (BP) target in patients with mild to moderate hypertension. (defined as mean sitting Systolic Blood Pressure [msSBP] ≥ 140 mmHg and < 180 mmHg and/or mean sitting Diastolic Blood Pressure [msDBP] ≥ 90 and <110 mmHg).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Outpatients ≥ 18 years of age
- •Patients with a diagnosis of mild to moderate hypertension at Visit 1
- •All patients must have a msSBP ≥ 140 mmHg and < 180 mmHg and/or msDBP ≥ 90 mmHg and < 110 mmHg mmHg at Visit 3
排除标准
- •Severe hypertension defined as msSBP ≥ 180 mmHg and/or msDBP ≥ 110 mmHg
- •Secondary form of hypertension
- •Current diagnosis of heart failure (NYHA Class II-IV)
- •Current angina pectoris requiring pharmacological therapy (other than stable doses of oral or topical nitrates)
- •Second or third degree heart block without a pacemaker
- •Concurrent potentially life threatening arrhythmia or symptomatic arrhythmia, atrial fibrillation or atrial flutter, during the 12 months prior to Visit 1
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Aliskiren-based regimen
All pts starting on aliskiren 150 mg (uptitrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (uptitrated to 25 mg) and amlodipine 5 mg (uptitrated to 10 mg), as necessary to achieve the Blood Pressure goal.
干预措施: Aliskiren (Drug)
Aliskiren-based regimen
All pts starting on aliskiren 150 mg (uptitrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (uptitrated to 25 mg) and amlodipine 5 mg (uptitrated to 10 mg), as necessary to achieve the Blood Pressure goal.
干预措施: Hydrochlorothiazide (Drug)
Aliskiren-based regimen
All pts starting on aliskiren 150 mg (uptitrated to aliskiren 300 mg), followed by the addition of HCTZ 12.5 mg (uptitrated to 25 mg) and amlodipine 5 mg (uptitrated to 10 mg), as necessary to achieve the Blood Pressure goal.
干预措施: Amlodipine (Drug)
结局指标
主要结局
Percentage of Participants (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped Care, Aliskiren-based Regimen
时间窗: 24 weeks
For non diabetic patients the Blood Pressure target is defined as mean sitting Systolic Blood Pressure \[msSBP\] \< 140 mmHg and mean sitting Diastolic Blood Pressure \[msDBP\] \< 90 mmHg and for diabetic patients the Blood Pressure target is mean sitting Systolic Blood Pressure \[msSBP\] \< 130 mmHg and mean sitting Diastolic Blood Pressure \[msDBP\] \< 80 mmHg.
次要结局
- Changes From Baseline to Week 24 in Mean Sitting Systolic Blood Pressure [msSBP] and Mean Sitting Diastolic Blood Pressure [msDBP](Baseline and Week 24)
- Percent of Responders for Mean Sitting Systolic Blood Pressure [msSBP] and for Mean Sitting Diastolic Blood Pressure [msDBP](24 weeks)
- Percentage of Patients (Defined as Estimated Cumulative Control Rate) Reaching Blood Pressure Target in a Stepped-care, Aliskiren-based Regimen by Patient Subgroups of Mild and Moderate Hypertensive Patients, and Non-diabetic and Diabetic Patients.(24 weeks)