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

Phase 3

Terminated

• Conditions: Pulmonary Hypertension
• Interventions: Drug: Inhaled Iloprost (5 μg); Drug: Inhaled Placebo; Drug: Sildenafil; Drug: Bosentan

• Registration Number: NCT00302211
• Lead Sponsor: Actelion

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

Not available

Study Timeline

• Study Start: 2006-02-01
• Study First Submitted: 2006-03-10
• Study First Submitted QC: 2006-03-10
• Study First Posted: 2006-03-14
• Primary Completion: 2007-12-01
• Study Completion: 2008-07-01
• Results First Submitted: 2010-05-27
• Results First Submitted QC: 2010-07-20
• Results First Posted: 2010-08-13
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-31
• Last Update Posted: 2025-02-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 67

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
DB inhaled iloprost 6x/day	Inhaled Iloprost (5 μg)	inhaled iloprost (5 μg) 6 times per day (6×/day) plus sildenafil with or without bosentan during the double blind period
DB inhaled iloprost 4x/day	Inhaled Placebo	Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan during the double blind period
DB inhaled placebo 6x/day	Inhaled Placebo	Inhaled placebo 6×/day plus sildenafil with or without bosentan during the double blind period
OL inhaled iloprost 6x/day	Inhaled Iloprost (5 μg)	Inhaled iloprost (5 μg) 6 times per day (6×/day) plus sildenafil with or without bosentan during the Open-Label treatment period
OL inhaled iloprost 4x/day	Inhaled Iloprost (5 μg)	Inhaled iloprost (5 μg) 4 times per day (4×/day) plus sildenafil with or without bosentan during the Open-Label treatment period
DB inhaled iloprost 4x/day	Inhaled Iloprost (5 μg)	Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan during the double blind period
DB inhaled iloprost 6x/day	Bosentan	inhaled iloprost (5 μg) 6 times per day (6×/day) plus sildenafil with or without bosentan during the double blind period
DB inhaled iloprost 6x/day	Sildenafil	inhaled iloprost (5 μg) 6 times per day (6×/day) plus sildenafil with or without bosentan during the double blind period
DB inhaled iloprost 4x/day	Sildenafil	Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan during the double blind period
DB inhaled placebo 6x/day	Bosentan	Inhaled placebo 6×/day plus sildenafil with or without bosentan during the double blind period
DB inhaled iloprost 4x/day	Bosentan	Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan during the double blind period
DB inhaled placebo 6x/day	Sildenafil	Inhaled placebo 6×/day plus sildenafil with or without bosentan during the double blind period

Primary Outcome Measures

Name	Time	Method
Absolute Change From Baseline to Week 16 in 6-Minute Walk Distance (6MWD) During the Double-blind Treatment Period	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 Outcome Measures

Name	Time	Method
Number of Subjects With WHO Functional Class (WHO FC) Improvement at Week 16	Day 1 and Week 16	This test is used to assess disease severity. Four fucntional classes (FC) are defined from FC I (no limitation of physical activity) to FC IV (inability to carry out any physical activity without symptoms). Improvement is considered when a participant changes from a higher class to a lower class.
Time to Clinical Worsening	Week 16 and Week 48	Clinical worsening is defined as one of the following: death due to worsening PAH, receipt of lung or heart-lung transplantation, or atrial septostomy, hospitalization for worsening PAH, any early discontinuation from study during the blinded or open-label phase due to worsening PAH, initiation of additional PAH-specific treatment. Due to insufficient data, time could not be assessed accurately and only number of patients with clinical worsening could be reported.