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

Last updated: January 31, 2025
Sponsor: Actelion
Overall Status: Terminated

Phase

3

Condition

Pulmonary Arterial Hypertension

Congestive Heart Failure

Lung Disease

Treatment

Inhaled Placebo

Sildenafil

Bosentan

Clinical Study ID

NCT00302211
C200-006
  • Ages 12-85
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Aged 12-85 years; of either gender.

  • Confirmed PAH due to idiopathic pulmonary arterial hypertension (IPAH) or familialpulmonary 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

Exclusion Criteria:

  • Any treatment for PAH with prostacyclins, prostacyclin analogues, endothelin-1antagonists, or phosphodiesterase-5 (PDE-5) inhibitors other than sildenafil withinthe past 12 weeks.

  • Pulmonary hypertension due to conditions other than those stated in inclusioncriteria.

  • Additional PAH medications added within the past 12 weeks.

Study Design

Total Participants: 67
Treatment Group(s): 4
Primary Treatment: Inhaled Placebo
Phase: 3
Study Start date:
February 01, 2006
Estimated Completion Date:
July 01, 2008

Connect with a study center

  • Pulmonary Associates, PA

    Phoenix, Arizona 85006
    United States

    Site Not Available

  • University of California San Diego Medical Center

    La Jolla, California 92037
    United States

    Site Not Available

  • GLVA Medical Center

    Los Angeles, California 90073
    United States

    Site Not Available

  • UCLA Medical Offices

    Los Angeles, California 90095
    United States

    Site Not Available

  • University of California Davis School of Medicine

    Sacramento, California 95817
    United States

    Site Not Available

  • University of California San Francisco Medical Center

    San Francisco, California 94143
    United States

    Site Not Available

  • Stanford University Medical Center

    Stanford, California 94305-5351
    United States

    Site Not Available

  • University of Colorado Health Services

    Denver, Colorado 80262
    United States

    Site Not Available

  • University of Connecticut Health Center

    Farmington, Connecticut 06030-1321
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • Midwest Heart Foundation

    Lombard, Illinois 60148
    United States

    Site Not Available

  • Midwest Heart Specialists, Edwards Hospital

    Lombard, Illinois 60148
    United States

    Site Not Available

  • University of Iowa Hospital

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Site Not Available

  • LSU Health Sciences Center

    New Orleans, Louisiana 70112
    United States

    Site Not Available

  • University of Maryland Hospital

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Massachusetts General Hospital

    Boston, Massachusetts 02114
    United States

    Site Not Available

  • Tufts New England Medical Center

    Boston, Massachusetts 02111
    United States

    Site Not Available

  • Spectrum Blodgett Hospital

    Grand Rapids, Michigan 49506
    United States

    Site Not Available

  • Minneapolis Heart Institute

    Minneapolis, Minnesota 55407
    United States

    Site Not Available

  • North Shore University Hospital

    New Hyde Park, New York 11040
    United States

    Site Not Available

  • Beth Israel Medical Center

    New York, New York 10003
    United States

    Site Not Available

  • Columbia University Medical Center

    New York, New York 10032
    United States

    Site Not Available

  • New York Presbyterian Hospital

    New York, New York 10032
    United States

    Site Not Available

  • Ohio State University

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Alleghany General Hospital

    Pittsburgh, Pennsylvania 15212
    United States

    Site Not Available

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • University of SC School of Medicine

    Columbia, South Carolina 29203
    United States

    Site Not Available

  • Baylor College of Medicine

    Houston, Texas 77030
    United States

    Site Not Available

  • Diagnostic Research Group

    San Antonio, Texas 78229
    United States

    Site Not Available

  • LDS Hospital

    Salt Lake City, Utah 84143
    United States

    Site Not Available

  • University of Washington Medical Center

    Seattle, Washington 98195
    United States

    Site Not Available

  • Heart Care Associates, LLC

    Milwaukee, Wisconsin 53215
    United States

    Site Not Available

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