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

Phase 3TerminatedNCT00302211

Actelion67 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Pulmonary Hypertension

Interventions

Inhaled Iloprost (5 μg)DRUG

iloprost inhalation solution (Ventavis) (5 μg)

Inhaled PlaceboDRUG

inhaled placebo

SildenafilDRUG

oral sildenafil (dosage between 60 and 300 mg/day)

Eligibility

Sex: ALLMin age: 12 YearsMax age: 85 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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

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.

Time frame: Day 1 and Week 16

Secondary Outcomes

Number of Subjects With WHO Functional Class (WHO FC) Improvement at 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 frame: Day 1 and Week 16

Time to Clinical Worsening

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.

Time frame: Week 16 and Week 48

Data from ClinicalTrials.gov

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