An 8-week, Double-blind, Randomized, Parallel Group, Multi-center Study to Evaluate the Efficacy and Safety of the Combination of Aliskiren 300 mg and Amlodipine 10 mg Compared to Amlodipine 10 mg in Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 485
- 试验地点
- 1
- 主要终点
- Mean Sitting Systolic Blood Pressure (msSBP)
研究概览
简要总结
This study will compare the blood pressure (BP) lowering effect of the combination of aliskiren/amlodipine 300/10 mg versus amlodipine 10 mg monotherapy in patients with moderate to severe hypertension by testing the hypothesis that the combination of aliskiren/amlodipine produces a superior reduction from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment.
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
- •Outpatients ≥ 18 years of age
- •Patients with a diagnosis of moderate to severe hypertension, defined as msSBP ≥ 160 mmHg and < 200 mmHg at Visit 2
排除标准
- •Mild to moderate hypertension
- •Pregnant or nursing (lactating) women
- •Women of child-bearing potential
- •Previous or current diagnosis of heart failure New York Heart Association(NYHA) Class II-IV.
- •Serum potassium ≥ 5.3 mEq/L (mmol/L) at Visit
- •Uncontrolled Type 1 or Type 2 diabetes mellitus
- •Hypersensitivity to renin inhibitors, calcium channel blockers, or to drugs with Similar chemical structures
- •History of hypertensive encephalopathy or cerebrovascular accident, or history of transient ischemic attack (TIA), myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention
- •Patients on a combination of 3 or more antihypertensive medications
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
Aliskiren/amlodipine 300/10 mg tablet
Aliskiren/amlodipine treatment regimen: At randomization, patients were treated with aliskiren/amlodipine 150/5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive aliskiren/amlodipine 300/10 mg.
干预措施: Aliskiren/amlodipine 300/10 mg tablet (Drug)
Amlodipine 10 mg capsule
Amlodipine treatment regimen: At randomization, patients were treated with amlodipine 5 mg for one week. For the remaining 7 weeks of the study, patients were force-titrated to receive amlodipine 10 mg.
干预措施: Amlodipine 10 mg capsule (Drug)
结局指标
主要结局
Mean Sitting Systolic Blood Pressure (msSBP)
时间窗: Baseline to end of study (Week 8)
Change in mean sitting systolic blood pressure (msSBP) from baseline to end of study (Week 8)
次要结局
- Mean Sitting Diastolic Blood Pressure (msDBP)(Baseline to end of study (Week 8))
- Systolic Blood Pressure Response(Baseline to end of study (Week 8))
- Diastolic Blood Pressure Response(Baseline to end of study (Week 8))
- Blood Pressure Control(End of study (Week 8))