NCT00333307暂停1 期
A Phase I Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation Study to Evaluate the Safety of Recombinant Human Relaxin (rhRlx) in Subjects With Preeclampsia
Corthera, Inc.(formerly BAS Medical, Inc.), a member of the Novartis group of companies4 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2006年10月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 发起方
- 入组人数
- 18
- 试验地点
- 4
- 主要终点
- maternal adverse experiences
研究概览
简要总结
The purpose of this study is to determine whether different doses of recombinant human relaxin is safe when given to women with severe preeclampsia
详细描述
The effects of relaxin may be beneficial in the treatment of women with preeclampsia. This study will preliminarily evaluate the maternal, fetal and neonatal safety and tolerability of an IV infusion of relaxin compared with placebo given to women with severe preeclampsia.
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
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of preeclampsia
- •Hospital admission for expectant management
排除标准
- •Eclampsia or history of seizures
- •Vaginal bleeding
- •Multifetal gestation
- •Requirement for immediate delivery
结局指标
主要结局
maternal adverse experiences
fetal adverse experiences
neonatal adverse experiences
次要结局
- preeclampsia assessments
- vital signs
- physical examinations
- clinical laboratory assessments
研究者
研究点 (4)
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