The Pharmacokinetics and Pharmacodynamics of Sildenafil in Pediatric and Adult Patients
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- To define the PK of sildenafil administered as standard of care in infants with pulmonary hypertension
研究概览
简要总结
The study is being done to investigate what happens to sildenafil in the body and how long it takes to get rid of this drug. Understanding how long the drug stays in the body and how it is changed by the body will help doctors determine the best dose. We also want to learn how well the medicine works based on the size of the dose or amount in the bloodstream.
详细描述
There is no data regarding sildenafil drug disposition in infants and children with pulmonary hypertension. Sildenafil is used at The Children's Hospital of Philadelphia for the treatment of pulmonary hypertension. Patients receiving sildenafil as standard of care will be approached for consent.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 28 Days 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Receive enteral sildenafil as standard of care
- •> 28 days to >18 years of age
- •Informed consent/assent
排除标准
- •Parents/guardians and/or subjects who, in the opinion of the investigator, may be noncompliant with study schedules or procedures.
结局指标
主要结局
To define the PK of sildenafil administered as standard of care in infants with pulmonary hypertension
时间窗: predose, .5mins after dose, 2-4 hrs after dose, and 5-7 hrs after dose
次要结局
- To describe the PD effects of sildenafil administered as standard of care in infants and children with pulmonary hypertension.(Multiple time points throughout the study)