NCT00709865已完成3 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Assess the Safety and Tolerability of Intravenous Tonapofylline in Subjects With Acute Decompensated Heart Failure and Renal Insufficiency
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Biogen
- 入组人数
- 420
- 主要终点
- Assess the safety andtolerability of intravenous tonapofylline, when added to standard therapy in subjects hospitalized with ADHF and renal insufficiency.
研究概览
简要总结
The purpose of the current study is to assess the safety and tolerability of intravenous tonapofylline.
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
- Triple (Participant, Care Provider, 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
- •Previous diagnosis of heart failure.
- •Must have ADHF, requiring hospitalization, with clinical evidence for volume overload
排除标准
- •History of an allergic reaction to any xanthine-containing substance.
- •History of seizure
- •History of stroke
- •Myocardial infarction
- •Uncorrected hemodynamically significant primary valvular disease or known Obstructive or restrictive cardiomyopathy.
- •Serious systemic infection
- •Major surgical procedures within 30 days
- •Acute coronary syndrome
- •Cardiogenic shock
- •Baseline body weight >150 kg
- •Participation in any other investigational study of drugs or devices within 30 days prior to Screening
- •Nursing mothers, pregnant women, or women planning on becoming pregnant during the study
- •Presence of any clinically significant condition that might interfere with optimal safe participation in this study
研究组 & 干预措施
1
Experimental
.03 mg/kg
干预措施: tonapofylline (Drug)
2
Experimental
.15 mg/kg
干预措施: tonapofylline (Drug)
3
Experimental
.3 mg/kg
干预措施: tonapofylline (Drug)
4
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Assess the safety andtolerability of intravenous tonapofylline, when added to standard therapy in subjects hospitalized with ADHF and renal insufficiency.
时间窗: 0-60 days
次要结局
未报告次要终点
研究者
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