跳至主要内容
临床试验/NCT01799473
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

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

发起方
United Therapeutics
申办方类型
Industry
责任方
Sponsor

研究点 (50)

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