NCT00141310终止2 期
A Randomised, Double-Blind, Placebo-Controlled, Flexible-Dose, Parallel-Group Study to Evaluate the Efficacy, Safety and Toleration of Oral Sildenafil Citrate Administered in the Dose Range of 20 - 80 Mg TID for the Treatment of Pre-Eclampsia. (PET)
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.11 个研究点 分布在 1 个国家目标入组 76 人开始时间: 2004年9月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 76
- 试验地点
- 11
- 主要终点
- Primary endpoint is the time from randomization to delivery.
研究概览
简要总结
To determine the efficacy and safety of sildenafil citrate in the treatment of established pre-eclampsia
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects with pre-eclampsia defined as new hypertension with a diastolic BP of > or = 90 mmHg on two occasions separated by at least 4 hrs arising after 20 weeks of pregnancy, associated with >500 mg/24 hr proteinuria. Subjects with pre-existing hypertension (on treatment) need only fulfill proteinuria requirement.
- •Gestational age 24-34 w
- •Singleton pregnancy
排除标准
- •Where urgent delivery is indicated
- •Where the fetus is suspected to have a structural or chromosomal abnormality
结局指标
主要结局
Primary endpoint is the time from randomization to delivery.
次要结局
- Individualised birth-weight ratio at delivery, Placental weight, Umbilical artery pulsatility index, Other indices of PET (incl. uric acid and maternal BP), Safety and toleration, Population PK, Fetal exposure (PK)
研究者
研究点 (11)
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