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

Pulmonary Hypertension Clinical Trial

— VISION  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00302211
• Other study ID #: C200-006
• Status: Terminated
• Phase: Phase 3
• Start date: February 1, 2006
• Est. completion date: July 1, 2008

Study information

• Verified date: March 2019
• Source: Actelion
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 67
• Est. completion date: July 1, 2008
• Est. primary completion date: December 1, 2007
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Familial Primary Pulmonary Hypertension
• Hypertension
• Hypertension, Pulmonary
• Pulmonary Hypertension

Intervention

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

Locations

Country	Name	City	State
United States	University of Maryland Hospital	Baltimore	Maryland
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Tufts New England Medical Center	Boston	Massachusetts
United States	University of SC School of Medicine	Columbia	South Carolina
United States	Ohio State University	Columbus	Ohio
United States	University of Colorado Health Services	Denver	Colorado
United States	University of Connecticut Health Center	Farmington	Connecticut
United States	Spectrum Blodgett Hospital	Grand Rapids	Michigan
United States	Baylor College of Medicine	Houston	Texas
United States	University of Iowa Hospital	Iowa City	Iowa
United States	University of Kansas Medical Center	Kansas City	Kansas
United States	University of California San Diego Medical Center	La Jolla	California
United States	Midwest Heart Foundation	Lombard	Illinois
United States	Midwest Heart Specialists, Edwards Hospital	Lombard	Illinois
United States	GLVA Medical Center	Los Angeles	California
United States	UCLA Medical Offices	Los Angeles	California
United States	University of Miami	Miami	Florida
United States	Heart Care Associates, LLC	Milwaukee	Wisconsin
United States	Minneapolis Heart Institute	Minneapolis	Minnesota
United States	North Shore University Hospital	New Hyde Park	New York
United States	LSU Health Sciences Center	New Orleans	Louisiana
United States	Beth Israel Medical Center	New York	New York
United States	Columbia University Medical Center	New York	New York
United States	New York Presbyterian Hospital	New York	New York
United States	Pulmonary Associates, PA	Phoenix	Arizona
United States	Alleghany General Hospital	Pittsburgh	Pennsylvania
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	Rhode Island Hospital	Providence	Rhode Island
United States	University of California Davis School of Medicine	Sacramento	California
United States	LDS Hospital	Salt Lake City	Utah
United States	Diagnostic Research Group	San Antonio	Texas
United States	University of California San Francisco Medical Center	San Francisco	California
United States	University of Washington Medical Center	Seattle	Washington
United States	Stanford University Medical Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Actelion

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of Participants With Any Adverse Events	This is the overall number of participants in each group who reported at least one adverse event (i.e., any untoward medical occurrence or unfavorable and unintended sign whether or not considered related to the study drug) with an onset from the first administration of study drug up to the last study visit.	From Day 1 to Week 16 and Week 48
Primary	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.	Day 1 and Week 16
Secondary	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.	Day 1 and Week 16
Secondary	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.	Week 16 and Week 48