NCT00099580已完成2 期
PROCLAIM: A Phase 2, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multicenter Study to Examine the Effects of AC2592 Administered by Continuous Subcutaneous Infusion in Subjects With Advanced Chronic Congestive Heart Failure
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
- 61
- 试验地点
- 1
- 主要终点
- To examine the safety and tolerability of AC2592 administered by continuous subcutaneous infusion in subjects with chronic congestive heart failure.
研究概览
简要总结
This Phase 2, randomized, placebo-controlled, multicenter outpatient study is designed to test the safety and tolerability of AC2592 as well as examine the effect of AC2592 on oxygen consumption during maximal tolerated exercise in adult subjects with chronic congestive heart failure.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has heart failure classified as New York Heart Association (NYHA) Class III or Class IV at screening despite treatment with standard therapy.
- •Is able to perform a treadmill test.
- •Has an HbA1c of <= 11%.
- •Is physically and mentally capable of operating the continuous subcutaneous infusion (CSCI) pump (i.e., adequate vision, manual dexterity, and mental capacity), or has a dedicated caretaker or adult family member who meets this requirement.
排除标准
- •Has received metformin or nesiritide within 2 weeks prior to screening visit.
- •Is currently participating in any other clinical study, or has received an investigational drug within 1 month of the screening period.
- •Has participated previously in a study using GLP-1, exenatide, or exenatide LAR.
- •Is using a left ventricular assist device or other mechanical circulatory support.
研究组 & 干预措施
1
Experimental
干预措施: AC2592 (Drug)
2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
To examine the safety and tolerability of AC2592 administered by continuous subcutaneous infusion in subjects with chronic congestive heart failure.
时间窗: 6 weeks
To assess the effect of AC2592 administered by continuous subcutaneous infusion on oxygen consumption during maximal tolerated exercise in adult subjects with chronic congestive heart failure.
时间窗: 6 weeks
次要结局
- To assess the effect of AC2592 administered by continuous subcutaneous infusion on pharmacokinetics, pharmacodynamics, and clinical outcomes in adult subjects with chronic congestive heart failure.(6 weeks)
研究者
研究点 (1)
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