A 104 Week, Randomized, Double Blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy of Aliskiren on the Progression of Atherosclerosis in Patients With Coronary Artery Disease When Added to Optimal Background Therapy
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 613
- 试验地点
- 1
- 主要终点
- Change From Baseline in Percent Atheroma Volume(PAV) After 104 Weeks of Treatment
研究概览
简要总结
The study will assess the change in coronary atherosclerotic disease as determined by intravascular ultrasound (IVUS) for aliskiren compared to placebo when given in addition to standard therapy in patients with coronary artery disease (CAD) and a blood pressure in the pre-hypertensive range.
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with CAD who have blood pressure in the pre-hypertensive range defined as a msSBP ≥ 125 and ≤ 139mmHg and a msDBP < 90mmHg.
- •Patients with or without current treatment for hypertension
- •Angiographic evidence of coronary artery disease
- •At least 2 qualifying Cardiovascular risk factors at Visit 1
排除标准
- •Baseline IVUS determined unacceptable
- •Patients requiring treatment with disallowed study medications
- •Patients with clinically significant heart disease
- •Previous or current diagnosis of heart failure (NYHA Class IV) or a documented left ventricular ejection fraction of < 25%
- •Patients requiring treatment with any 2 of the following classes of medication at Visit 1 or Visit 2:
- •Angiotensin converting enzyme inhibitors
- •Angiotensin receptor blockers
- •aldosterone receptor blockers or a direct renin inhibitor.
- •Other conditions may apply
研究组 & 干预措施
1
干预措施: Placebo (Drug)
2
Aliskiren 300 mg
干预措施: Aliskiren (Drug)
结局指标
主要结局
Change From Baseline in Percent Atheroma Volume(PAV) After 104 Weeks of Treatment
时间窗: Baseline, 104 weeks
Change from baseline in PAV for all matched slices of anatomically comparable segments of the target coronary artery were assessed by intravascular ultrasound (IVUS) evaluation after 104 weeks of treatment . calculation for change is the value at the later time point minus the value at the earlier time point, with positive numbers to represent increases and negative numbers to represent decreases
次要结局
- Change in Normalized Total Atheroma Volume (TAV) as Assessed by IVUS(Baseline, 104 weeks)
- Patients That Demonstrated Evidence of Atheroma Regression(Baseline to endpoint (104 weeks))
- Number of Patients With Adverse Events, Serious Adverse Events, and Death(104 weeks)