NCT00219011已完成3 期
A Twelve-week, Randomized, Double-blind, Multi-center, Placebo Controlled, Parallel Group Study to Evaluate the Safety and Efficacy of Aliskiren 150 mg When Added to Standard Therapy in Hypertensive Patients With Stable Heart Failure
适应症
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
- 280
- 试验地点
- 2
- 主要终点
- Measurement of safety information and tolerability of drug after 12 weeks
研究概览
简要总结
This study was designed to determine if patients, who have both high blood pressure and heart failure and are currently receiving drug treatment for heart failure, have an improvement in their heart failure signs and symptoms and other indicators of heart failure after being treated with aliskiren on top of their current heart failure treatment. Aliskiren is an investigational drug; its safety will also be evaluated in this trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double
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
- •History of diagnosis or currently have high blood pressure
- •Stable heart failure (NYHA Class 2-4) for at least 1 month before study entry. Subject should be on a stable dose regimen of heart failure medication.
- •Brain natriuretic peptide (BNP) > 150 pg/ml at baseline (to be evaluated by physician at first visit)
排除标准
- •Previous treatment with aliskiren
- •High blood pressure due to secondary reasons or constant low blood pressure (systolic < 90 mmHg)
- •History of heart attack or coronary bypass surgery in the past 6 months
- •Other protocol-defined exclusion criteria may apply.
结局指标
主要结局
Measurement of safety information and tolerability of drug after 12 weeks
次要结局
- Changes in New York Heart Association heart failure stages after 12 weeks
- Change from baseline in the heart failure biochemical markers of N-terminal pro-brain natriuretic peptide (NT-proBNP) and brain natriuretic (BNP) after 12 weeks
- Change from baseline in mean sitting systolic and diastolic blood pressure after 12 weeks
- Change from baseline in aldosterone (a steroid hormone secreted by the adrenal cortex that regulates salt and water balance in the body) after 12 weeks
- Changes from baseline in the forces of the circulation of blood as measured by echocardiography to after 12 weeks
研究者
研究点 (2)
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