NCT03387215已完成1 期
Randomized, Double-Blind, Placebo-Controlled, Safety and Tolerability Study of Escalating Single Doses of ITI-214 in Patients With Systolic Heart Failure
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Echocardiogram with Doppler imaging and hemodynamic monitoring
研究概览
简要总结
This is a Phase I/II randomized, double-blind, placebo-controlled, single rising dose study in patients with systolic heart failure to evaluate the safety and tolerability of ITI-214.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •NYHA class II-III heart failure
- •Ejection fraction equal to or below 35%
- •On stable heart failure drug treatment
排除标准
- •Considered medically inappropriate for study participation
研究组 & 干预措施
10 mg ITI-214
Experimental
Single oral dose
干预措施: ITI-214 (Drug)
30 mg ITI-214
Experimental
Single oral dose
干预措施: ITI-214 (Drug)
75 mg - 150 mg ITI-214
Experimental
Single oral dose
干预措施: ITI-214 (Drug)
Placebo
Placebo Comparator
Single oral dose
干预措施: Placebo (Other)
结局指标
主要结局
Echocardiogram with Doppler imaging and hemodynamic monitoring
时间窗: 2 hours
Cardiac systolic and diastolic function
次要结局
- 12-lead electrocardiogram (ECG)(2 hours)
- Hemodynamic monitoring(5-6 hours)
- Number of patients with treatment-emergent adverse events(5 days)
研究者
研究点 (2)
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