NCT00004497已完成3 期
Phase III Randomized Study of UT-15 in Patients With Primary Pulmonary Hypertension
United Therapeutics13 个研究点 分布在 1 个国家开始时间: 1998年10月最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 试验地点
- 13
研究概览
简要总结
OBJECTIVES:
I. Determine the safety and efficacy of UT-15 in patients with severe symptomatic primary pulmonary hypertension.
详细描述
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are stratified according to center and etiology of disease.
Patients receive conventional oral therapy plus a continuous subcutaneous infusion of either UT-15 or placebo for 12 weeks.
After completing 12 weeks of treatment, patients may continue therapy with open label UT-15. Patients who received placebo cross over to receive UT-15.
Completion date provided represents the completion date of the grant per OOPD records
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- Double
入排标准
- 年龄范围
- 8 Years 至 75 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究者
研究点 (13)
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