NCT00748982已完成2 期
A Single-centre, Single-blind, Randomised, Placebo-controlled Phase IIa Study to Investigate the Effect of AZD1305 Given as an Intravenous (iv) Infusion on Left Ventricular Performance in Patients With Left Ventricular Dysfunction
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Left Ventricular Ejection Fraction (LVEF), Change From Baseline
研究概览
简要总结
To explore if AZD1305 compromises left ventricular performance in patients with left ventricular dysfunction
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
- •Male patients and postmenopausal women
- •Mildly/moderately decreased heart function
- •Regular heart rhythm
排除标准
- •Potassium outside normal reference values
- •Child bearing potential
- •Severely decreased heart function
研究组 & 干预措施
2
Placebo Comparator
干预措施: Placebo (Drug)
1
Experimental
干预措施: AZD1305 (Drug)
结局指标
主要结局
Left Ventricular Ejection Fraction (LVEF), Change From Baseline
时间窗: From the iv loading dose during 30 min and the following maintenance iv dose during a maximum of 90 min. The infusion was stopped when all echocardiographic measurements had been carried out
To explore if AZD1305 compromises left ventricular performance in patients with left ventricular dysfunction.
次要结局
- Number of Subjects With at Least One Reported Adverse Event During Each Study Period and in Each Dose Group(From randomisation to last study visit (mean infusion time 1.6 hours))
- Area Under Curve (AUC) ( µmol*h/L) of AZD1305(From the iv loading dose during 30 min and the following maintenance iv dose during a maximum of 90 min.)
- QTcF Interval(Up to 24 hours following start of IV dosing.)
研究者
研究点 (1)
Loading locations...
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