A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of AMG 334 on Exercise Time During a Treadmill Test in Subjects With Stable Angina
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Change From Baseline in Total Exercise Time
研究概览
简要总结
A phase 2a, multicenter, randomized, double-blind, placebo-controlled study in adults with stable angina to evaluate the effect of erenumab (AMG 334) compared to placebo on exercise time during an exercise treadmill test.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •Participating in another investigational study
- •Current or prior malignancy within 5 years of randomization
- •Known sensitivity to any components of the investigational product
- •Not able to complete all protocol required study visits
- •Having the following within 3 months prior to or during screening: Unstable angina or acute coronary syndrome, transient Ischemic attack (TIA) or stroke, revascularization procedure, or instability in ST-segment depression between screening exercise treadmill tests, as assessed by the core electrocardiograph (ECG) laboratory
研究组 & 干预措施
Placebo
Participants received a single dose of placebo administered by intravenous infusion on day 1.
干预措施: Placebo (Drug)
Erenumab
Participants received a single dose of erenumab 140 mg administered by intravenous infusion on day 1.
干预措施: Erenumab (Drug)
结局指标
主要结局
Change From Baseline in Total Exercise Time
时间窗: Baseline and day 1, after dosing
Total exercise time was assessed using an exercise treadmill test according to the standard Bruce protocol. The Bruce protocol is a standardized multistage treadmill test for assessing cardiovascular health, where the participant walks on an uphill treadmill in a graded exercise test with electrodes on the chest to monitor cardiac function. Every 3 minutes, the speed and incline of the treadmill are increased. There are 7 such stages for a total possible exercise time of 21 minutes.
次要结局
- Time to Onset of Exercise-induced Angina(Day 1)
- Time to Onset of ≥ 1 mm ST-segment Depression(Day 1)