NCT00571766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11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 in pregnant women with chronic hypertension during oral arginine or placebo treatment in 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 in pregnant women with chronic hypertension.
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
- 是
入选标准
- •Pregnant women between 18-20 week of gestation with chronic hypertension
排除标准
- •Maternal or fetal 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
Placebo 2 g, twice a day for 14 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
to evaluate blood pressure changes in pregnant women with chronic hypertension during oral arginine or placebo treatment in second trimester of gestation.
时间窗: 14 weeks
次要结局
- To evaluate if is necessary add a conventional therapy for hypertension, to evaluate the maternal and fetal outcomes and possible complications, to evaluate the safety of L-Arginine.(14 weeks)
研究者
研究点 (1)
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