EUCTR2011-001617-14-DE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:
- •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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