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

Condition(s) targeted: Pulmonary Hypertension

Intervention: Iloprost Inhalation Solution (Ventavis) (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Actelion

Official(s) and/or principal investigator(s):
Robyn J Barst, MD, Study Chair, Affiliation: Steering Committee Advisor
David B Badesch, MD, FACP, FCCP, Study Chair, Affiliation: Steering Committee Advisor

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.

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 design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Primary outcome: 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

Minimum age: 12 Years. Maximum age: 85 Years. Gender(s): Both.

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

Pulmonary Associates, PA, Phoenix, Arizona 85006, United States

University of California Davis School of Medicine, Sacramento, California 95817, United States

University of California San Diego Medical Center, La Jolla, California 92037, United States

Stanford University Medical Center, Stanford, California 94305-5351, United States

University of California San Francisco Medical Center, San Francisco, California 94143, United States

GLVA Medical Center, Los Angeles, California 90073, United States

UCLA Medical Offices, Los Angeles, California 90095, United States

University of Colorado Health Services, Denver, Colorado 80262, United States

University of Connecticut Health Center, Farmington, Connecticut 06030-1321, United States

University of Miami, Miami, Florida 33136, United States

Midwest Heart Specialists, Edwards Hospital, Lombard, Illinois 60148, United States

Midwest Heart Foundation, Lombard, Illinois 60148, United States

University of Iowa Hospital, Iowa City, Iowa 52242, United States

University of Kansas Medical Center, Kansas City, Kansas 66160, United States

LSU Health Sciences Center, New Orleans, Louisiana 70112, United States

University of Maryland Hospital, Baltimore, Maryland 21201, United States

Tufts New England Medical Center, Boston, Massachusetts 02111, United States

Massachusetts General Hospital, Boston, Massachusetts 02114, United States

Spectrum Blodgett Hospital, Grand Rapids, Michigan 49506, United States

Minneapolis Heart Institute, Minneapolis, Minnesota 55407, United States

Columbia University Medical Center, New York, New York 10032, United States

New York Presbyterian Hospital, New York, New York 10032, United States

North Shore University Hospital, New Hyde Park, New York 11040, United States

Beth Israel Medical Center, New York, New York 10003, United States

Ohio State University, Columbus, Ohio 43210, United States

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania 15213, United States

Alleghany General Hospital, Pittsburgh, Pennsylvania 15212, United States

Rhode Island Hospital, Providence, Rhode Island 02903, United States

University of SC School of Medicine, Columbia, South Carolina 29203, United States

Diagnostic Research Group, San Antonio, Texas 78229, United States

Baylor College of Medicine, Houston, Texas 77030, United States

LDS Hospital, Salt Lake City, Utah 84143, United States

University of Washington Medical Center, Seattle, Washington 98195, United States

Heart Care Associates, LLC, Milwaukee, Wisconsin 53215, United States

CoTherix Clinical Development

Starting date: March 2006
Last updated: January 30, 2008