Conditions: Pulmonary Hypertension
Keywords: PAH Pulmonary Arterial Hypertension
Allocation: RANDOMIZED | Intervention model: FACTORIAL
Enrollment: 67
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: inhaled iloprost (5 μg) 6 times per day (6×/day) plus sildenafil with or without bosentan during the double blind period arm 2: Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan during the double blind period arm 3: Inhaled placebo 6×/day plus sildenafil with or without bosentan during the double blind period arm 4: Inhaled iloprost (5 μg) 6 times per day (6×/day) plus sildenafil with or without bosentan during the Open-Label treatment period arm 5: Inhaled iloprost (5 μg) 4 times per day (4×/day) plus sildenafil with or without bosentan during the Open-Label treatment period

Interventions: intervention 1: Inhaled Iloprost (5 μg) intervention 2: Inhaled Placebo intervention 3: Sildenafil intervention 4: Bosentan
Intervention descriptions: intervention 1: iloprost inhalation solution (Ventavis) (5 μg) intervention 2: inhaled placebo intervention 3: oral sildenafil (dosage between 60 and 300 mg/day) intervention 4: oral bosentan (dosage between 62.5 and 125 mg BID)

Protocol document: