The "VISION" Trial: Ventavis Inhalation With Sildenafil to Improve and Optimize Pulmonary Arterial Hypertension

Actelion Pharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: Pulmonary Hypertension

Treatments: Drug: Inhaled Placebo; Drug: Bosentan; Drug: Sildenafil; Drug: Inhaled Iloprost (5 μg)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00302211

C200-006

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 12 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Double Blind

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67 participants in 5 patient groups, including a placebo group

DB inhaled iloprost 6x/day

Experimental group

Description:

inhaled iloprost (5 μg) 6 times per day (6×/day) plus sildenafil with or without bosentan during the double blind period

Treatment:

Drug: Inhaled Iloprost (5 μg)

Drug: Sildenafil

Drug: Bosentan

DB inhaled iloprost 4x/day

Experimental group

Description:

Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan during the double blind period

Treatment:

Drug: Inhaled Iloprost (5 μg)

Drug: Sildenafil

Drug: Bosentan

Drug: Inhaled Placebo

DB inhaled placebo 6x/day

Placebo Comparator group

Description:

Inhaled placebo 6×/day plus sildenafil with or without bosentan during the double blind period

Treatment:

Drug: Sildenafil

Drug: Bosentan

Drug: Inhaled Placebo

OL inhaled iloprost 6x/day

Experimental group

Description:

Inhaled iloprost (5 μg) 6 times per day (6×/day) plus sildenafil with or without bosentan during the Open-Label treatment period

Treatment:

Drug: Inhaled Iloprost (5 μg)

OL inhaled iloprost 4x/day

Experimental group

Description:

Inhaled iloprost (5 μg) 4 times per day (4×/day) plus sildenafil with or without bosentan during the Open-Label treatment period

Treatment:

Drug: Inhaled Iloprost (5 μg)