Phase II Study of Nicotinamide in Early Onset Preeclampsia
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Change in Mean Arterial Blood Pressure (MAP)
研究概览
简要总结
Phase II Study of 2.5 gm of nicotinamide, given daily in 3 divided doses, to measure effect on maternal blood pressure in women with early onset preeclampsia and to determine peak and trough levels of nicotinamide. We will compare peak and trough levels in healthy non-pregnant and healthy pregnant participants.
详细描述
See brief summary above
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Nicotinamide - pre-eclampsia
All participants will receive study agent
干预措施: nicotinamide (Drug)
Nicotinamide - healthy pregnant
All participants will receive study agent 1000mg in single dose
干预措施: nicotinamide (Drug)
Healthy Non-Pregnant
All participants will receive study agent 1000mg in single dose
干预措施: nicotinamide (Drug)
结局指标
主要结局
Change in Mean Arterial Blood Pressure (MAP)
时间窗: Baseline, 48 hours
Blood pressure (mmHg) will be used to observe the effect of nicotinamide. The highest MAP (defined as the highest MAP within the 24 hour period prior to the administration of study agent) and the highest MAP through 24 hours after study drug administration.
次要结局
- Percentage of Fetuses With Category III Non Stress Test Results(From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks)
- Percentage of Fetuses With Biophysical Profile < 6(From initial administration of study agent until 24 hours post last dose)
- Mean Peak Nicotinamide Level(at 1 hour post 1000 mg nicotinamide administration on Day 1)
- Mean Trough Concentration Nicotinamide Administration(8 hours after the 8 a.m. 1000 mg nicotimamide administration on Day 1)
- Percentage of Women With Hematocrit Decrease of More Than 3%(From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks)
- Percentage of Women With Headache Unrelieved by Oral Analgesics(From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks)
- Number of Participants With Alanine Aminotransferase (ALT) =/> 3x Upper Limit of Normal (ULN)(Within 24 hours of any dose, up to a maximum 4 weeks)
- Percentage of Women Maternal Abdominal Tenderness(From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks)
- Percentage of Women With Less Than 500 cc Urine Output in 24 Hours(From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks)
- Number of Participants With Aspartate Aminotransferase (AST) =/> 3x Upper Limit of Normal (ULN)(Within 24 hours of any dose, up to a maximum 4 weeks)
- Number of Participants With Maternal Side Effects(From initial administration of study agent until 24 hours post last dose, up to a maximum of 4 weeks)