The "VISION" Trial: Ventavis Inhalation With Sildenafil to Improve and Optimize Pulmonary Arterial Hypertension
- Conditions
- Pulmonary Hypertension
- Interventions
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 67
- 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.
- 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.
Trial Locations
- Locations (34)
University of Maryland Hospital
🇺🇸Baltimore, Maryland, United States
GLVA Medical Center
🇺🇸Los Angeles, California, United States
University of Connecticut Health Center
🇺🇸Farmington, Connecticut, United States
Tufts New England Medical Center
🇺🇸Boston, Massachusetts, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
Beth Israel Medical Center
🇺🇸New York, New York, United States
UCLA Medical Offices
🇺🇸Los Angeles, California, United States
North Shore University Hospital
🇺🇸New Hyde Park, New York, United States
LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
University of California Davis School of Medicine
🇺🇸Sacramento, California, United States
Spectrum Blodgett Hospital
🇺🇸Grand Rapids, Michigan, United States
University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
University of California San Francisco Medical Center
🇺🇸San Francisco, California, United States
University of Colorado Health Services
🇺🇸Denver, Colorado, United States
University of Miami
🇺🇸Miami, Florida, United States
Minneapolis Heart Institute
🇺🇸Minneapolis, Minnesota, United States
Diagnostic Research Group
🇺🇸San Antonio, Texas, United States
Pulmonary Associates, PA
🇺🇸Phoenix, Arizona, United States
University of Iowa Hospital
🇺🇸Iowa City, Iowa, United States
Heart Care Associates, LLC
🇺🇸Milwaukee, Wisconsin, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
University of California San Diego Medical Center
🇺🇸La Jolla, California, United States
Midwest Heart Specialists, Edwards Hospital
🇺🇸Lombard, Illinois, United States
Midwest Heart Foundation
🇺🇸Lombard, Illinois, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
New York Presbyterian Hospital
🇺🇸New York, New York, United States
LDS Hospital
🇺🇸Salt Lake City, Utah, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
Alleghany General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
University of SC School of Medicine
🇺🇸Columbia, South Carolina, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
Rhode Island Hospital
🇺🇸Providence, Rhode Island, United States