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

This study has been terminated.
(Terminated due to slow enrollment)
Sponsor:
Information provided by:
Actelion
ClinicalTrials.gov Identifier:
NCT00302211
First received: March 10, 2006
Last updated: May 12, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention Phase
Pulmonary Hypertension
Drug: Iloprost Inhalation Solution (Ventavis)
Drug: Inhaled Placebo
Drug: Sildenafil
Drug: Bosentan
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • Number of Participants With Change From Baseline to Week 16 in 6-Minute Walk Test (MWT) in Double-blind, Modified Intent To Treat (MITT) Population [ Time Frame: Day 1 to Week 16 ] [ Designated as safety issue: No ]
    Comparing number of Modified Intent to Treat population in double-blind who improved in the 6-minute walk distance - from baseline distance between 100-450 meters. Any increase in walk distance was considered improvement from baseline. The 6-minute walks were measured in meters using a test administrator, a stop watch, and markers to identify the course.


Secondary Outcome Measures:
  • Assess the Efficacy of the Addition of Inhaled Iloprost in Patients With PAH Receiving a Stable Dose of Oral Sildenafil [ Time Frame: Baseline Week 16 up to 48 weeks ] [ Designated as safety issue: No ]
    The change in 6-minute walk distance (6-MWD) measured after inhalation, following 16 weeks of combination therapy with inhaled iloprost (administered 6 times or 4 times per day) inhaled iloprost plus sildenafil during the open-label extension phase.


Enrollment: 67
Study Start Date: February 2006
Study Completion Date: November 2009
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A
Inhaled iloprost(5 μg) 6×/day + sildenafil ± bosentan
Drug: Iloprost Inhalation Solution (Ventavis)
iloprost inhalation solution (Ventavis) (5 mcg) 6×/day
Drug: Sildenafil
oral sildenafil (dosage between 60 and 300 mg/day)
Drug: Bosentan
oral bosentan (dosage between 62.5 and 125 mg BID)
Experimental: Group B
Inhaled iloprost (5 μg) 4×/day + sildenafil ± bosentan
Drug: Iloprost Inhalation Solution (Ventavis)
iloprost inhalation solution (Ventavis) (5 mcg) 4×/day
Drug: Sildenafil
oral sildenafil (dosage between 60 and 300 mg/day)
Drug: Bosentan
oral bosentan (dosage between 62.5 and 125 mg BID)
Placebo Comparator: Group C
Inhaled placebo 6×/day + sildenafil ± bosentan
Drug: Inhaled Placebo
inhaled placebo 6×/day (5 mcg)
Drug: Sildenafil
oral sildenafil (dosage between 60 and 300 mg/day)
Drug: Bosentan
oral bosentan (dosage between 62.5 and 125 mg BID)

  Eligibility

Ages Eligible for Study:   12 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00302211

  Hide Study Locations
Locations
United States, Arizona
Pulmonary Associates, PA
Phoenix, Arizona, United States, 85006
United States, California
University of California San Diego Medical Center
La Jolla, California, United States, 92037
UCLA Medical Offices
Los Angeles, California, United States, 90095
GLVA Medical Center
Los Angeles, California, United States, 90073
University of California Davis School of Medicine
Sacramento, California, United States, 95817
University of California San Francisco Medical Center
San Francisco, California, United States, 94143
Stanford University Medical Center
Stanford, California, United States, 94305-5351
United States, Colorado
University of Colorado Health Services
Denver, Colorado, United States, 80262
United States, Connecticut
University of Connecticut Health Center
Farmington, Connecticut, United States, 06030-1321
United States, Florida
University of Miami
Miami, Florida, United States, 33136
United States, Illinois
Midwest Heart Specialists, Edwards Hospital
Lombard, Illinois, United States, 60148
Midwest Heart Foundation
Lombard, Illinois, United States, 60148
United States, Iowa
University of Iowa Hospital
Iowa City, Iowa, United States, 52242
United States, Kansas
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
United States, Louisiana
LSU Health Sciences Center
New Orleans, Louisiana, United States, 70112
United States, Maryland
University of Maryland Hospital
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Tufts New England Medical Center
Boston, Massachusetts, United States, 02111
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
United States, Michigan
Spectrum Blodgett Hospital
Grand Rapids, Michigan, United States, 49506
United States, Minnesota
Minneapolis Heart Institute
Minneapolis, Minnesota, United States, 55407
United States, New York
North Shore University Hospital
New Hyde Park, New York, United States, 11040
New York Presbyterian Hospital
New York, New York, United States, 10032
Beth Israel Medical Center
New York, New York, United States, 10003
Columbia University Medical Center
New York, New York, United States, 10032
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
Alleghany General Hospital
Pittsburgh, Pennsylvania, United States, 15212
United States, Rhode Island
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
United States, South Carolina
University of SC School of Medicine
Columbia, South Carolina, United States, 29203
United States, Texas
Baylor College of Medicine
Houston, Texas, United States, 77030
Diagnostic Research Group
San Antonio, Texas, United States, 78229
United States, Utah
LDS Hospital
Salt Lake City, Utah, United States, 84143
United States, Washington
University of Washington Medical Center
Seattle, Washington, United States, 98195
United States, Wisconsin
Heart Care Associates, LLC
Milwaukee, Wisconsin, United States, 53215
Sponsors and Collaborators
Actelion
Investigators
Study Chair: Robyn J Barst, MD Steering Committee Advisor
Study Chair: David B Badesch, MD, FACP, FCCP Steering Committee Advisor
Principal Investigator: Ardeschir Ghofrani, MD Medizinische Klinik und Poliklinik II Univer GieBen
Principal Investigator: Nazzareno Galie, MD Istituto Malattie Apparato Cardio Univ di Bologna
  More Information

Additional Information:
No publications provided

Responsible Party: Actelion Pharmaceuticals US/Sponsor, Actelion Pharmaceuticals US
ClinicalTrials.gov Identifier: NCT00302211     History of Changes
Other Study ID Numbers: C200-006
Study First Received: March 10, 2006
Results First Received: May 27, 2010
Last Updated: May 12, 2011
Health Authority: United States: Food and Drug Administration

Keywords provided by Actelion:
PAH
Pulmonary Arterial Hypertension

Additional relevant MeSH terms:
Hypertension, Pulmonary
Hypertension
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Cardiovascular Diseases
Pharmaceutical Solutions
Iloprost
Sildenafil
Bosentan
Therapeutic Uses
Pharmacologic Actions
Platelet Aggregation Inhibitors
Hematologic Agents
Vasodilator Agents
Cardiovascular Agents
Antihypertensive Agents
Phosphodiesterase 5 Inhibitors
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Urological Agents

ClinicalTrials.gov processed this record on August 21, 2014