NCT03045029进行中（未招募）不适用
ADAPT - a Patient Registry of the Real-world Use of Orenitram®
United Therapeutics41 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2017年7月18日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 300
- 试验地点
- 41
- 主要终点
- Real-world use and tolerability of Orenitram in new starts and prostacyclin transition patients
研究概览
简要总结
This prospective, observational, multicenter, patient registry will follow patients who are receiving treatment with Orenitram for the treatment of PAH for up to 78 weeks from Orenitram initiation
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
- 18 Years 至 —（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
研究组 & 干预措施
Oral treprostinil
Sustained-release oral tablets for three times daily (TID) administration in prostacyclin naive and prostacyclin transition patients
干预措施: Oral treprostinil (Drug)
结局指标
主要结局
Real-world use and tolerability of Orenitram in new starts and prostacyclin transition patients
时间窗: Baseline to Week 78
次要结局
- To assess treatment-related outcomes during routine clinical care.(Baseline to Week 78)
- To evaluate information on clinical titration schedules implemented for transition to and from alternative prostacyclin-class therapies(Baseline to Week 78)
- Health-related quality of life in PAH and treatment satisfaction(Baseline to Week 78)
- To observe the development, timing, severity, frequency, and treatment of prostacyclin-related adverse events (AEs) of interest(Baseline to Week 78)
- Healthcare resource utilization trends(Baseline to Week 78)
- To evaluate reasons for discontinuation of Orenitram(Baseline to Week 78)
- To evaluate titration and dosing schedules of Orenitram(Baseline to Week 78)
- Use of concomitant medications(Baseline to Week 78)
研究者
研究点 (41)
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