NCT01799473已完成不适用
A Patient Registry to Observe the Real-World Dosing and Titration of Tyvaso®
United Therapeutics50 个研究点 分布在 2 个国家目标入组 98 人开始时间: 2013年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 98
- 试验地点
- 50
- 主要终点
- Observe dose changes of Tyvaso over time
研究概览
简要总结
This prospective, observational, multi-center, patient registry will follow patients who are newly initiated on Tyvaso for the treatment of Pulmonary Arterial Hypertension (PAH). Once enrolled, the patients' dose and titration will be followed for the first 6 months of treatment with Tyvaso.
A call-center will contact the patients directly at weeks 1, 2, 3, 4, 8, 12, 16, 20, and 24 to review their dose and titration schedule. In addition to patient-reported dosing data, some patient demographic information, will be collected by the investigative site at Baseline.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are newly prescribed Tyvaso for the treatment of PAH and plan to initiate therapy
- •Are willing and able to be contacted by the patient call center.
排除标准
- •Have previously received Tyvaso.
- •Are currently enrolled in an interventional (non-FDA approved) PH clinical trial.
结局指标
主要结局
Observe dose changes of Tyvaso over time
时间窗: 6 Months
次要结局
未报告次要终点
研究者
研究点 (50)
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