NCT00741819已完成4 期
An Open Label, Multi-center Study Evaluating the Safety of Long-term Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis® (Iloprost) in Subjects With Pulmonary Arterial Hypertension.
United Therapeutics15 个研究点 分布在 1 个国家目标入组 73 人开始时间: 2008年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 73
- 试验地点
- 15
- 主要终点
- Number of Adverse Events
研究概览
简要总结
This is a 24-month, multi-center, prospective, open-label, safety evaluation in PAH subjects following transition from a stable dose of inhaled iloprost (Ventavis).
Subjects are to be evaluated for safety throughout the course of the study while secondary assessments will be conducted at Baseline, Week 6, Week 12, and Months 6, 12, 18 and 24 following initiation of treprostinil sodium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Between 18 and 75 years of age
- •PAH diagnosis defined by following WHO Group I categories: idiopathic/familial, associated with unrepaired or repaired congenital systemic-to-pulmonary shunts (repaired >/= 5 years), associated with collagen vascular disease, associated with HIV, associated with appetite suppressant/toxin use
- •Baseline six-minute walk distance (6MWD) >/= 250 meters
- •Currently receiving Ventavis and be stable at current dose for 30 days prior to Baseline
- •If currently receiving other approved background therapy (i.e. endothelin receptor antagonist or phosphodiesterase-5-inhibitor or both) must be on stable dose for 30 days prior to Baseline
- •Previous testing (e.g. right heart catheterization, echocardiography) consistent with diagnosis of PAH
排除标准
- •Nursing or pregnant
- •Has acute concomitant disease (e.g. portal hypertension, chronic thromboembolic disease, pulmonary veno-occlusive disease, etc) other than those accepted as part of the inclusion criteria or has had atrial septostomy
- •History of uncontrolled sleep apnea, left-sided heart disease, or parenchymal lung disease
- •Use of investigational drug within 30 days of Baseline
研究组 & 干预措施
Inhaled treprostinil
Experimental
Solution for oral inhalation treprostinil (0.6 mg/mL). Inhaled via an ultrasonic nebulizer which provides a dose of 6mcg of treprostinil per breath. Doses are titrated up to 12 breaths four times daily.
干预措施: Inhaled treprostinil (Drug)
结局指标
主要结局
Number of Adverse Events
时间窗: up to 24 months
Overall safety of transitioning from inhaled iloprost to inhaled treprostinil was assessed by type and frequency of adverse events.
次要结局
- Six-minute Walk Distance (6MWD)(Baseline and 12 weeks)
- Quality of Life (QoL) Assessment: Cambridge Pulmonary Hypertension Outcome Review (CAMPHOR)(Baseline and 12 weeks)
- Treatment Satisfaction Questionnaire of Medication (TSQM)(Baseline and 12 weeks)
- Patient Impression of Change(Baseline and 12 weeks)
- N-terminal Prohormone of Brain Natriuretic Peptide (NT-proBNP)(Baseline and Week 12)
- World Health Organization (WHO) Functional Class(Baseline and 12 Weeks)
- Drug Administration Activities Questionnaire(Baseline and 12 weeks)
研究者
研究点 (15)
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