Phase IV Study of Chronic Infusional Epoprostenol for Severe Primary Pulmonary Hypertension
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
研究概览
简要总结
OBJECTIVES: I. Provide epoprostenol (Flolan, prostaglandin I2) by chronic infusion to patients with severe primary pulmonary hypertension for whom no alternative therapy is available.
II. Obtain additional safety information on continuous infusion epoprostenol. III. Obtain additional information on economic resource health consumption.
详细描述
PROTOCOL OUTLINE: Patients are treated with a chronic continuous infusion of epoprostenol.
The highest tolerated infusion rate is determined for each patient by gradually increasing the rate until the target dose is reached or the patient experiences at least 1 dose-limiting effect.
Patients are subsequently treated with a chronic continuous infusion, beginning at a rate below the highest tolerated rate. Attempts are made to increase the dose to the highest tolerated rate over the first 72 hours.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 0 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •PROTOCOL ENTRY CRITERIA:
- •Severe primary pulmonary hypertension
- •Able to prepare and self-administer medication
排除标准
- 未提供