NCT00974714已完成3 期
Effects of Oral L-arginine on Chronic Hypertension in Pregnancy
University of Modena and Reggio Emilia1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2007年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- to evaluate blood pressure changes during oral L-arginine or placebo administration in pregnant women with chronic hypertension at second trimester of gestation
研究概览
简要总结
The purpose of this study is to evaluate the effects of oral L-arginine administration on pregnant women at second trimester of gestation with chronic hypertension, respect with placebo.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Pregnant women between 18-20 weeks of gestation with chronic hypertension
排除标准
- •Other maternal or fetal systemic disease
研究组 & 干预措施
1
Experimental
Oral L-arginine 2 g twice a day, for 14 weeks
干预措施: L-arginine (Drug)
2
Placebo Comparator
oral placebo twice a day for 14 weeks
干预措施: placebo (Other)
结局指标
主要结局
to evaluate blood pressure changes during oral L-arginine or placebo administration in pregnant women with chronic hypertension at second trimester of gestation
时间窗: 14 weeks
次要结局
- evaluate if is necessary to add a conventional therapy for hypertension, to evaluate pregnancy outcomes and eventual complications, to evaluate safety of oral L-arginine administration(14 weeks)
研究者
研究点 (1)
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