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

NCT00302211 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2025-02-04

Study results available
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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

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)

Sponsors & Collaborators

  • Actelion

    lead INDUSTRY

Principal Investigators

  • Nazzareno Galie, MD · Istituto Malattie Apparato Cardio Univ di Bologna

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
FACTORIAL

Eligibility

Min Age
12 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-02-01
Primary Completion
2007-12-01
Completion
2008-07-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00302211 on ClinicalTrials.gov