EUCTR2011-001617-14-IT进行中（未招募）不适用
An adaptive multicentre, randomized, partially doubleblind, placebo controlled study to assess the safety, PK and PD/efficacy of RLX030 in women with pre-eclampsia
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •- Women that are 28- 33 weeks (+4 days) pregnant with a diagnosis of pre- eclampsia or superimposed pre-eclampsia requiring hospitalization - Fetus deemed in reasonably good health Other protocol-defined inclusion criteria may apply
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Severe hypertension and /or those receiving anti-hypertensive treatment at time of enrollment - Severe headaches, visual changes, or altered mentation - Upper abdominal pain, nausea, or vomiting - Low blood platelet count - Diagnosis of a seizure disorder that requires chronic medication - Those receiving active anti-coagulation therapy - Pre-gestational diabetes (Type 1 or Type 2) - Allergy to magnesium sulfate or steroids - Known major fetal anomaly - Multifetal gestation Other protocol-defined exclusion criteria may apply
研究者
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