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

Primary Purpose

Pulmonary Hypertension

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Inhaled Iloprost (5 μg)
Inhaled Placebo
Sildenafil
Bosentan
Sponsored by
Actelion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Hypertension focused on measuring PAH, Pulmonary Arterial Hypertension

Eligibility Criteria

12 Years - 85 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Pulmonary Associates, PA
  • University of California San Diego Medical Center
  • GLVA Medical Center
  • UCLA Medical Offices
  • University of California Davis School of Medicine
  • University of California San Francisco Medical Center
  • Stanford University Medical Center
  • University of Colorado Health Services
  • University of Connecticut Health Center
  • University of Miami
  • Midwest Heart Foundation
  • Midwest Heart Specialists, Edwards Hospital
  • University of Iowa Hospital
  • University of Kansas Medical Center
  • LSU Health Sciences Center
  • University of Maryland Hospital
  • Tufts New England Medical Center
  • Massachusetts General Hospital
  • Spectrum Blodgett Hospital
  • Minneapolis Heart Institute
  • North Shore University Hospital
  • Beth Israel Medical Center
  • Columbia University Medical Center
  • New York Presbyterian Hospital
  • Ohio State University
  • Alleghany General Hospital
  • University of Pittsburgh Medical Center
  • Rhode Island Hospital
  • University of SC School of Medicine
  • Baylor College of Medicine
  • Diagnostic Research Group
  • LDS Hospital
  • University of Washington Medical Center
  • Heart Care Associates, LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

DB inhaled iloprost 6x/day

DB inhaled iloprost 4x/day

DB inhaled placebo 6x/day

OL inhaled iloprost 6x/day

OL inhaled iloprost 4x/day

Arm Description

inhaled iloprost (5 μg) 6 times per day (6×/day) plus sildenafil with or without bosentan during the double blind period

Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan during the double blind period

Inhaled placebo 6×/day plus sildenafil with or without bosentan during the double blind period

Inhaled iloprost (5 μg) 6 times per day (6×/day) plus sildenafil with or without bosentan during the Open-Label treatment period

Inhaled iloprost (5 μg) 4 times per day (4×/day) plus sildenafil with or without bosentan during the Open-Label treatment period

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 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.

Full Information

First Posted
March 10, 2006
Last Updated
March 26, 2019
Sponsor
Actelion
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1. Study Identification

Unique Protocol Identification Number
NCT00302211
Brief Title
The "VISION" Trial: Ventavis Inhalation With Sildenafil to Improve and Optimize Pulmonary Arterial Hypertension
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Terminated
Why Stopped
Terminated due to slow enrollment
Study Start Date
February 1, 2006 (Actual)
Primary Completion Date
December 1, 2007 (Actual)
Study Completion Date
July 1, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Actelion

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Hypertension
Keywords
PAH, Pulmonary Arterial Hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Factorial Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
67 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DB inhaled iloprost 6x/day
Arm Type
Experimental
Arm Description
inhaled iloprost (5 μg) 6 times per day (6×/day) plus sildenafil with or without bosentan during the double blind period
Arm Title
DB inhaled iloprost 4x/day
Arm Type
Experimental
Arm Description
Inhaled iloprost (5 μg) 4×/day plus inhaled placebo 2x/day plus sildenafil with or without bosentan during the double blind period
Arm Title
DB inhaled placebo 6x/day
Arm Type
Placebo Comparator
Arm Description
Inhaled placebo 6×/day plus sildenafil with or without bosentan during the double blind period
Arm Title
OL inhaled iloprost 6x/day
Arm Type
Experimental
Arm Description
Inhaled iloprost (5 μg) 6 times per day (6×/day) plus sildenafil with or without bosentan during the Open-Label treatment period
Arm Title
OL inhaled iloprost 4x/day
Arm Type
Experimental
Arm Description
Inhaled iloprost (5 μg) 4 times per day (4×/day) plus sildenafil with or without bosentan during the Open-Label treatment period
Intervention Type
Drug
Intervention Name(s)
Inhaled Iloprost (5 μg)
Intervention Description
iloprost inhalation solution (Ventavis) (5 μg)
Intervention Type
Drug
Intervention Name(s)
Inhaled Placebo
Intervention Description
inhaled placebo
Intervention Type
Drug
Intervention Name(s)
Sildenafil
Intervention Description
oral sildenafil (dosage between 60 and 300 mg/day)
Intervention Type
Drug
Intervention Name(s)
Bosentan
Intervention Description
oral bosentan (dosage between 62.5 and 125 mg BID)
Primary Outcome Measure Information:
Title
Absolute Change From Baseline to Week 16 in 6-Minute Walk Distance (6MWD) During the Double-blind Treatment Period
Description
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 Outcome Measure Information:
Title
Number of Subjects With WHO Functional Class (WHO FC) Improvement at Week 16
Description
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
Title
Time to Clinical Worsening
Description
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
Other Pre-specified Outcome Measures:
Title
Number of Participants With Any Adverse Events
Description
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.
Time Frame
From Day 1 to Week 16 and Week 48

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nazzareno Galie, MD
Organizational Affiliation
Istituto Malattie Apparato Cardio Univ di Bologna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pulmonary Associates, PA
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
University of California San Diego Medical Center
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Facility Name
GLVA Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90073
Country
United States
Facility Name
UCLA Medical Offices
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California Davis School of Medicine
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California San Francisco Medical Center
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305-5351
Country
United States
Facility Name
University of Colorado Health Services
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States
Facility Name
University of Connecticut Health Center
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06030-1321
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Midwest Heart Foundation
City
Lombard
State/Province
Illinois
ZIP/Postal Code
60148
Country
United States
Facility Name
Midwest Heart Specialists, Edwards Hospital
City
Lombard
State/Province
Illinois
ZIP/Postal Code
60148
Country
United States
Facility Name
University of Iowa Hospital
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
LSU Health Sciences Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University of Maryland Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Tufts New England Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Spectrum Blodgett Hospital
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49506
Country
United States
Facility Name
Minneapolis Heart Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
North Shore University Hospital
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Beth Israel Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Alleghany General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
University of SC School of Medicine
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29203
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Diagnostic Research Group
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
LDS Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84143
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Heart Care Associates, LLC
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www1.actelion.com/en/healthcare-professionals/products/ventavis/index.page
Description
CoTherix Clinical Development

Learn more about this trial

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

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