NCT01120327已完成4 期
A Pilot Study Exploring Efficacy and Safety of Amlodipine in the Stented Angina Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 211
- 试验地点
- 2
- 主要终点
- Exercise capacity
研究概览
简要总结
- OBJECTIVES
Primary objective to evaluate the difference of the peak oxygen uptake change (VO2 max, mL/kg/min) in amlodipine group against no CCB group at 9 months
Secondary objectives To evaluate the change of sublingual nitrate use per day against no CCB group at 1 and 3 months To evaluate the change of biomarkers against no CCB group at 9 months 2. SUBJECTS AND CENTERS 212, stable angina patients with angiographically confirmed significant residual stenosis 10, 3rd-grade, teaching hospitals in Korea
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
- Single (Participant)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Stable angina patient with angiographically confirmed significant residual stenosis
- •Stenosis more than 50% in 2 major coronary arteries at least or Stenosis more than 75% in 1 major coronary artery
排除标准
- •No other pulmonary/psychiatry/musculoskeletal disorder limiting CPET
- •Contraindicated to the CPET (e.g. unstable angina, aortic stenosis, uncontrolled hypertension, uncontrolled asthma, hypoxemia at rest, epilepsy, locomotor disorder, severe hypertension and febrile illness)
研究组 & 干预措施
Amlodipine
Experimental
Amlodipine
干预措施: Amlodipine (Drug)
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Exercise capacity
时间窗: 9 months
Difference of the peak oxygen uptake change (VO2 max, mL/kg/min)
次要结局
- Sublingual Nitrate(1month and 3 months)
- Biomarkers(9 months)
研究者
Hyo-Soo Kim
Investigator
Seoul National University Hospital
研究点 (2)
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