NCT00706134已完成3 期
An Eight-week Double-blind, Multi-center, Randomized, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Aliskiren 75 mg, 150 mg, and 300 mg in Elderly Patients With Essential Hypertension When Given With a Light Meal
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 756
- 试验地点
- 1
- 主要终点
- Change in Mean Sitting Systolic Blood Pressure (msSBP)From Baseline to End of Study (Week 8)
研究概览
简要总结
This study will evaluate the efficacy and safety of aliskiren 75 mg, 150 mg, and 300 mg in elderly patients with essential hypertension when given with a light meal.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female outpatients 65 years of age and older.
- •Patients who are eligible and able to participate in the study, and who consent to do so after the purpose and nature of the investigation has been clearly explained to them (written informed consent).
- •At the randomization visit patients must have an office msSBP greater than or equal to 150 mmHg and < 180 mmHg (msDBP <110 mmHg) with a less than or equal to 15 mmHg difference during the last two visits of the single blind run-in period.
排除标准
- •Severe hypertension [Office msDBP ≥110 mmHg and/or mean sitting systolic blood pressure (msSBP) ≥ 180 mmHg].
- •History or evidence of a secondary form of hypertension.
- •Known Keith-Wagener grade III or IV hypertensive retinopathy.
- •History of hypertensive encephalopathy or cerebrovascular accident, including a history of transient ischemic cerebral attack (TIA).
- •Current diagnosis of heart failure (NYHA Class II-IV).
- •History of myocardial infarction, coronary bypass surgery, or any percutaneous coronary intervention (PCI).
- •Current angina pectoris requiring pharmacological therapy other than nitrates.
- •Other protocol-defined inclusion/exclusion criteria applied to the study.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Aliskiren 75 mg
Experimental
干预措施: Aliskiren 75 mg (Drug)
Aliskiren 150 mg
Experimental
干预措施: Aliskiren 150 mg (Drug)
Aliskiren 300 mg
Experimental
干预措施: Aliskiren 300 mg (Drug)
结局指标
主要结局
Change in Mean Sitting Systolic Blood Pressure (msSBP)From Baseline to End of Study (Week 8)
时间窗: Baseline to end of study (Week 8)
次要结局
- Change in Mean Sitting Diastolic Blood Pressure (msDBP) From Baseline to End of Study (Week 8)(Baseline to end of study (Week 8))
- Percentage of Patients Achieving Systolic Blood Pressure Response(Baseline to end of study (Week 8))
- Change in Mean 24 Hour Ambulatory Systolic and Diastolic Blood Pressure From Baseline to End of Study(Baseline to end of study (Week 8))
- Change in the Smoothness Index (SI) of the Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8)(Baseline to end of study (Week 8))
- Change in Morning Surge of Ambulatory Systolic Blood Pressure From Baseline to End of Study (Week 8)(Baseline to end of study (week 8))
研究者
研究点 (1)
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