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临床试验/NCT00902603
NCT00902603终止不适用

Registry to Prospectively Evaluate Use of Ventavis® in Patients With Pulmonary Arterial Hypertension

Actelion0 个研究点目标入组 148 人开始时间: 2009年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
发起方
入组人数
148
主要终点
Adherence with instructions for use of Ventavis®

研究概览

简要总结

The Ventavis® (iloprost) Registry is a multicenter, observational, U.S.-based study that longitudinally follows patients with pulmonary arterial hypertension (PAH) who have been receiving therapy with Ventavis® for at least 3 months. Patients diagnosed with WHO Group I PAH who are on a stable regimen of commercial Ventavis® will be followed for a maximum of 2 years from the time of enrollment. Data will be collected via patient interview and review of the medical record. Quarterly data collection will include capture of medications and Ventavis® adherence data.

详细描述

The Ventavis® (iloprost) Registry is a multicenter, observational, U.S.-based study that longitudinally follows patients with pulmonary arterial hypertension (PAH) who have been receiving therapy with Ventavis® for at least 3 months. Patients diagnosed with WHO Group I PAH and who are on a stable regimen of commercial Ventavis® will be followed for a maximum of 2 years from the time of enrollment. All data will be collected via patient interview and/or review of the medical record, as well as from I-neb® downloads using INSIGHT software. Adherence with Ventavis® will be compared before and after targeted instruction on inhalation techniques by a respiratory therapist or designee, as well as before and after participation in PAH patient support groups (if applicable). Quarterly data collection will include capture of PAH and non-PAH medications and Ventavis® adherence data; Ventavis® adherence data will also be collected one month after study entry.

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
19 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Have a current diagnosis of WHO Group I PAH
  • Have initiated therapy with commercial Ventavis® administered via portable nebulizer at least 3 months prior to study enrollment, either with commercial product or from participation in Actelion's Clinical Study AC-063A302
  • Age > or = 18 years old at the time of enrollment

排除标准

  • Meet the criteria for inclusion into WHO Groups II, III, IV or V PAH
  • Are not currently on commercial Ventavis®
  • Have initiated therapy with commercial Ventavis® administered via portable nebulizer less than 3 months prior to study enrollment

研究组 & 干预措施

1

Patients with WHO Group I pulmonary arterial hypertension (PAH) who have been receiving therapy with Ventavis® for at least 3 months.

干预措施: Commercial Ventavis® (iloprost) (Drug)

结局指标

主要结局

Adherence with instructions for use of Ventavis®

时间窗: 2 years

次要结局

  • Persistence of use of Ventavis®(2 years)

研究者

发起方
Actelion
申办方类型
Industry
责任方
Sponsor

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