NCT00302211

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

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

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Actelion · Industry
• Sex: All
• Age: 12 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Hypertension

Interventions

Type	Name	Description
DRUG	Inhaled Iloprost (5 μg)	iloprost inhalation solution (Ventavis) (5 μg)
DRUG	Inhaled Placebo	inhaled placebo
DRUG	Sildenafil	oral sildenafil (dosage between 60 and 300 mg/day)
DRUG	Bosentan	oral bosentan (dosage between 62.5 and 125 mg BID)

Timeline

• Start date: 2006-02-01
• Primary completion: 2007-12-01
• Completion: 2008-07-01
• First posted: 2006-03-14
• Last updated: 2025-02-04
• Results posted: 2010-08-13