NCT00159861已完成3 期
A Multinational, Multi-Center, Randomised, Double-Bind, Placebo-Controlled, Parallel Group Study to Assess the Safety and Efficacy of a Subject Optimised Dose of Sildenafil Citrate (20, 40, or 80 mg. Sildenafil Citrate TID) Based on the Toleration, When Used in Combination With Intravenous Prostacyclin( Epoprostenol) in the Treatment of Pulmonary Arterial Hypertension.
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.53 个研究点 分布在 11 个国家目标入组 267 人开始时间: 2003年7月1日最近更新:
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试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 267
- 试验地点
- 53
- 主要终点
- Categorized Change From Baseline in 6-Minute Walking Distance
研究概览
简要总结
Determination of the effects of sildenafil citrate and epoprostenol when used in combination in patients with pulmonary arterial hypertension
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with pulmonary arterial hypertension caused by primary PAH, associated with connective tissue disease or following surgical repair of a congenital heart lesion
排除标准
- •PH other than PAH
结局指标
主要结局
Categorized Change From Baseline in 6-Minute Walking Distance
时间窗: 1 Year, 2 Year, 3 Year
Number of subjects with categorized change in 6-minute walking distance. Distance that a subject could walk in 6-minutes at a comfortable pace with as many breaks as needed. Performed as close to trough levels of sildenafil as possible (just before dosing; at least 4 hours after the previous dose of study drug). Scores for categorized changes for missing visits were imputed as the worse score of its non-missing neighbors. If a visit was missing and there was no subsequent score, the score was coded to missing.
次要结局
- Change From Baseline in European Quality of Life (EuroQol) Visual Analogue Scale (EQ-5D VAS): Current Health State Score(Baseline, Month 15, Month 27, Month 39)
- Change in Pulmonary Hypertension Criteria for Functional Capacity and Therapeutic Class(1 Year, 2 Year, 3 Year)
- Change From Baseline in BORG Dyspnea Score(Baseline, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Month 9, Month 12, Month 15, Month 18, Month 21, Month 24, Month 27, Month 30, Month 33, Month 36)
- Survival Status(1, 2, 3, 4, and 5 years)
- Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36)(Baseline, Month 15, Month 27, Month 39)
- Change From Baseline in European Quality of Life Scale (EuroQol) 5-Dimensions (EQ-5D): Utility Index Score(Baseline, Month 15, Month 27, Month 39)
- Change From Baseline in Medical Outcomes Study Short Form 36 (SF-36): Reported Health Transition Score(Baseline, Month 15, Month 27, Month 39)
研究者
研究点 (53)
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