A Randomized, Double-blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of the Addition of Inhaled Iloprost in Patients With Pulmonary Arterial Hypertension Receiving Oral Sildenafil
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 67
- 主要终点
- Absolute Change From Baseline to Week 16 in 6-Minute Walk Distance (6MWD) During the Double-blind Treatment Period
研究概览
简要总结
The purpose of this multi-center international trial is to evaluate the safety and effectiveness of adding iloprost or placebo (an inactive substance that contains no active study drug) to sildenafil therapy for pulmonary arterial hypertension (PAH). The study will also examine whether patients on sildenafil can reduce the number of iloprost inhalations from the approved 6 doses per day to 4 doses per day.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 85 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 12-85 years; of either gender.
- •Confirmed PAH due to idiopathic pulmonary arterial hypertension (IPAH) or familial pulmonary arterial hypertension (FPAH).
- •6-minute walk distance (6-MWD) between 100-450 meters at screening.
- •On a stable dose of sildenafil, with or without bosentan.
排除标准
- •Any treatment for PAH with prostacyclins, prostacyclin analogues, endothelin-1 antagonists, or phosphodiesterase-5 (PDE-5) inhibitors other than sildenafil within the past 12 weeks.
- •Pulmonary hypertension due to conditions other than those stated in inclusion criteria.
- •Additional PAH medications added within the past 12 weeks.
研究组 & 干预措施
DB inhaled iloprost 6x/day
inhaled iloprost (5 μg) 6 times per day (6×/day) plus sildenafil with or without bosentan during the double blind period
干预措施: Inhaled Iloprost (5 μg) (Drug)
DB inhaled iloprost 6x/day
inhaled iloprost (5 μg) 6 times per day (6×/day) plus sildenafil with or without bosentan during the double blind period
干预措施: Sildenafil (Drug)
DB inhaled iloprost 6x/day
inhaled iloprost (5 μg) 6 times per day (6×/day) plus sildenafil with or without bosentan during the double blind period
干预措施: Bosentan (Drug)
DB inhaled iloprost 4x/day
Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan during the double blind period
干预措施: Inhaled Iloprost (5 μg) (Drug)
DB inhaled iloprost 4x/day
Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan during the double blind period
干预措施: Inhaled Placebo (Drug)
DB inhaled iloprost 4x/day
Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan during the double blind period
干预措施: Sildenafil (Drug)
DB inhaled iloprost 4x/day
Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan during the double blind period
干预措施: Bosentan (Drug)
DB inhaled placebo 6x/day
Inhaled placebo 6×/day plus sildenafil with or without bosentan during the double blind period
干预措施: Inhaled Placebo (Drug)
DB inhaled placebo 6x/day
Inhaled placebo 6×/day plus sildenafil with or without bosentan during the double blind period
干预措施: Sildenafil (Drug)
DB inhaled placebo 6x/day
Inhaled placebo 6×/day plus sildenafil with or without bosentan during the double blind period
干预措施: Bosentan (Drug)
OL inhaled iloprost 6x/day
Inhaled iloprost (5 μg) 6 times per day (6×/day) plus sildenafil with or without bosentan during the Open-Label treatment period
干预措施: Inhaled Iloprost (5 μg) (Drug)
OL inhaled iloprost 4x/day
Inhaled iloprost (5 μg) 4 times per day (4×/day) plus sildenafil with or without bosentan during the Open-Label treatment period
干预措施: Inhaled Iloprost (5 μg) (Drug)
结局指标
主要结局
Absolute Change From Baseline to Week 16 in 6-Minute Walk Distance (6MWD) During the Double-blind Treatment Period
时间窗: Day 1 and Week 16
The 6MWD test is a non-encouraged test, performed in a 30-meter long flat corridor, where the patient is instructed to walk as far as possible, back and forth around two cones during 6 minutes. They can slow down, rest, or stop if needed. This test is used to assess exercise capacity. The test was performed about 30 minutes after study drug administration. Any increase in the walk distance was considered improvement from baseline.
次要结局
- Number of Subjects With WHO Functional Class (WHO FC) Improvement at Week 16(Day 1 and Week 16)
- Time to Clinical Worsening(Week 16 and Week 48)