NCT00735085终止2 期
A Randomized, Double Blind, Placebo-Controlled Dose Escalation Study to Investigate the Safety and Pharmacokinetics After Single and Multiple Doses of SLV334 in Sequential Cohorts of Patients With Moderate and Severe Traumatic Brain Injury
Abbott Products14 个研究点 分布在 4 个国家目标入组 57 人开始时间: 2009年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 57
- 试验地点
- 14
- 主要终点
- Safety of SLV334 including mortality, adverse events (AE), serious adverse events (SAE), vitals signs, laboratory variables and ECG
研究概览
简要总结
A Randomized, Double Blind, Placebo Controlled, Phase 2 Dose Escalation Study to Investigate the Safety and Pharmacokinetics after Single and Multiple I.V. Doses of SLV334 in Sequential Cohorts of Patients with Moderate and Severe Traumatic Brain Injury.
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
- 16 Years 至 65 Years（Child, 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
- 未提供
研究组 & 干预措施
SLV334
Experimental
干预措施: SLV334 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Safety of SLV334 including mortality, adverse events (AE), serious adverse events (SAE), vitals signs, laboratory variables and ECG
时间窗: 2 weeks
次要结局
- PK parameters of SLV334(up to 4 days)
研究者
研究点 (14)
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