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
Overview
- Phase
- Phase 3
- Intervention
- Inhaled Iloprost (5 μg)
- Conditions
- Pulmonary Hypertension
- Sponsor
- Actelion
- Enrollment
- 67
- Primary Endpoint
- Absolute Change From Baseline to Week 16 in 6-Minute Walk Distance (6MWD) During the Double-blind Treatment Period
- Status
- Terminated
- Last Updated
- last year
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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
Intervention: Inhaled Iloprost (5 μg)
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
Intervention: Sildenafil
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
Intervention: Bosentan
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
Intervention: Inhaled Iloprost (5 μg)
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
Intervention: Inhaled Placebo
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
Intervention: Sildenafil
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
Intervention: Bosentan
DB inhaled placebo 6x/day
Inhaled placebo 6×/day plus sildenafil with or without bosentan during the double blind period
Intervention: Inhaled Placebo
DB inhaled placebo 6x/day
Inhaled placebo 6×/day plus sildenafil with or without bosentan during the double blind period
Intervention: Sildenafil
DB inhaled placebo 6x/day
Inhaled placebo 6×/day plus sildenafil with or without bosentan during the double blind period
Intervention: Bosentan
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
Intervention: Inhaled Iloprost (5 μg)
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
Intervention: Inhaled Iloprost (5 μg)
Outcomes
Primary Outcomes
Absolute Change From Baseline to Week 16 in 6-Minute Walk Distance (6MWD) During the Double-blind Treatment Period
Time Frame: 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.
Secondary Outcomes
- 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)