NCT00853957已完成4 期
An 8-week Multicenter, Randomized, Double-blind, Active Control, Parallel Group Study to Evaluate the Efficacy and Safety of Aliskiren Administered in Combination With Amlodipine (150/5 mg, 300/10 mg) Versus Amlodipine Alone (5 mg, 10 mg) in African American Patients With Stage 2 Hypertension
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 443
- 试验地点
- 1
- 主要终点
- Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
研究概览
简要总结
The purpose of the study is to evaluate the BP-lowering efficacy of the combination of aliskiren and amlodipine, as initial therapy, compared to amlodipine monotherapy in African American patients with Stage II hypertension.
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
- •Men or women of African American background; self identified
- •Patients with stage 2 hypertension defined as MSSBP ≥ 160 mmHg and < 200 mmHg at Visit 5 (randomization
排除标准
- •Office blood pressure measured by cuff (MSDBP ≥ 110 mmHg and/or MSSBP ≥ 200 mmHg)
- •Patients on 4 or more antihypertensive medications.
- •Patients with uncontrolled hypertension (MSSBP >180 mmHg) taking more than 1 antihypertensive medication at Visit 1
- •Refractory hypertension, defined as, unresponsive to triple drug therapy at the maximum dose of each drug, one of which must be a diuretic, and not at blood pressure goal (140/90 mmHg). Therapy with a fixed dose combination of two active substances represent two drugs.
- •History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
- •Evidence of a secondary form of hypertension, including but not limited to any of the following:
- •coarctation of the aorta
- •hyperaldosteronism
- •unilateral or bilateral renal artery stenosis
- •Cushing's disease
- •polycystic kidney disease
- •pheochromocytoma
- •Known Keith-Wagener grade III or IV hypertensive retinopathy.
- •History of angioedema due to usage of an ARB or ACE inhibitor.
- •History of hypertensive encephalopathy, cerebrovascular accident, transient ischemic attack, heart failure (NYHA Class II-IV), coronary bypass graft surgery (CABG), percutaneous coronary intervention (PCI), unstable angina pectoris, or myocardial infarction in the last 12 months
- •Other protocol defined inclusion/exclusion criteria applied
研究组 & 干预措施
Aliskiren/Amlodipine
Experimental
Aliskiren/Amlodipine 150 mg/5 mg titrated to 300 mg/10 mg
干预措施: Aliskiren/Amlodipine (Drug)
Amlodipine
Active Comparator
Amlodipine 5mg titrated to 10 mg
干预措施: Amlodipine (Drug)
结局指标
主要结局
Change From Baseline in Mean Sitting Systolic Blood Pressure (msSBP)
时间窗: Baseline, 8 weeks
To compare the change from baseline in mean sitting systolic blood pressure (msSBP) after 8 weeks of treatment with a combination of aliskiren and amlodipine treatment regimen (150/5 mg, 300/10 mg) versus an amlodipine treatment regimen (5 mg, 10 mg) in African American patients with Stage 2 hypertension.
次要结局
- Change From Baseline in Mean Sitting Diastolic Blood Pressure (msDBP)(Baseline, 8 weeks)
- Percentage of Patients Achieving Blood Pressure (BP) Control (<140/90 mmHg)(8 weeks)
- Percentage of Responders (Patients With MSSBP < 140 mmHg or Decrease From Baseline of Greater Than or Equal to 20 mmHg)(8 weeks)
- Change From Baseline in MSSBP at Week 1 and 4(Baseline, 1 and 4 weeks)
- Percentage of Patients With Peripheral Edema by Visit(8 weeks)
研究者
研究点 (1)
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