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

Sponsor:	Actelion
Information provided by:	Actelion
ClinicalTrials.gov Identifier:	NCT00302211

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)	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Factorial Assignment, Safety/Efficacy Study
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:

Genetics Home Reference related topics: pulmonary arterial hypertension

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension

Drug Information available for: Iloprost Sildenafil Sildenafil citrate

U.S. FDA Resources

Further study details as provided by Actelion:

Primary Outcome Measures:

The primary measure will be the change in 6-minute walk distance from baseline, measured after inhalation, following 16 weeks of combination therapy with inhaled iloprost (administered 6 times per day) and sildenafil vs. inhaled placebo plus sildenafil [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]

Estimated Enrollment:	180
Study Start Date:	March 2006
Estimated Study Completion Date:	December 2008
Estimated Primary Completion Date:	November 2008 (Final data collection date for primary outcome measure)

Intervention Details:

Patients receiving Iloprost Inhalation Solution (Ventavis)and bosentan in combination with sildenafil

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

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

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Locations

United States, Arizona
Pulmonary Associates, PA
Phoenix, Arizona, United States, 85006
United States, California
University of California Davis School of Medicine
Sacramento, California, United States, 95817
University of California San Diego Medical Center
La Jolla, California, United States, 92037
Stanford University Medical Center
Stanford, California, United States, 94305-5351
University of California San Francisco Medical Center
San Francisco, California, United States, 94143
GLVA Medical Center
Los Angeles, California, United States, 90073
UCLA Medical Offices
Los Angeles, California, United States, 90095
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
Columbia University Medical Center
New York, New York, United States, 10032
New York Presbyterian Hospital
New York, New York, United States, 10032
North Shore University Hospital
New Hyde Park, New York, United States, 11040
Beth Israel Medical Center
New York, New York, United States, 10003
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
Diagnostic Research Group
San Antonio, Texas, United States, 78229
Baylor College of Medicine
Houston, Texas, United States, 77030
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

More Information

Additional Information:

CoTherix Clinical Development This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Actelion Pharmaceuticals US ( Actelion Pharmaceuticals US/Sponsor )
Study ID Numbers:	C200-006
Study First Received:	March 10, 2006
Last Updated:	August 26, 2009
ClinicalTrials.gov Identifier:	NCT00302211 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Actelion:

PAH
Pulmonary Arterial Hypertension

Additional relevant MeSH terms:

Vasodilator Agents
Molecular Mechanisms of Pharmacological Action
Hematologic Agents
Vascular Diseases
Enzyme Inhibitors
Sildenafil
Cardiovascular Agents
Pharmacologic Actions
Iloprost

Phosphodiesterase Inhibitors
Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases
Therapeutic Uses
Cardiovascular Diseases
Platelet Aggregation Inhibitors
Hypertension

ClinicalTrials.gov processed this record on November 27, 2009