Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With Pulmonary Arterial Hypertension (PAH)

Completed · Phase 2 · Has a placebo group

Conditions studied: Pulmonary Arterial Hypertension, Ayerza Syndrome, Pulmonary Hypertension

In brief

The purpose of this study is to determine the safety and efficacy of Iloprost in subjects that have Pulmonary Arterial Hypertension who are concurrently taking bosentan (Tracleer TM).

Key facts

Study ID

NCT00086463

Run by

Actelion

People needed

60

Starts

2004-06-01

Expected to finish

2006-01-01

Last updated by the study team

2011-04-01

Who can join

Age: 12 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of PAH due to PPH, connective tissue disease, HIV, or repaired (≥ 1 year) ASD, VSD, or PDA
• NYHA Functional Class III or IV
• On bosentan for at least 16 weeks, with the dose stable (maximum dose 125 mg BID) for at least 8 weeks
• Age 12-75 years, of either gender
• Six minute walk distance 100-425 meters at Baseline

You may not qualify if…

• Any new long-term treatment for PAH added within the last 4 weeks
• Any therapy with a PDE (phosphodiesterase), L -arginine or a prostaglandin, concurrently, or within the last 4 weeks
• PAH related to chronic thromboembolic disease, portopulmonary disease, or any etiology other than PPH, connective tissue disease, HIV, or repaired ASD, VSD, or PDA

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• UCSD Medical Center — La Jolla, California, United States
• Stanford University Medical Center — Palo Alto, California, United States
• UCSF Medical Center — San Francisco, California, United States
• Harbor-UCLA Medical Center — Torrance, California, United States
• The Children's Hospital — Denver, Colorado, United States
• University of Colorado HSC — Denver, Colorado, United States
• Rush Heart Institute, Center for Pulmonary Heart Disease — Chicago, Illinois, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• University of Michigan — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Columbia University Medical Center — New York, New York, United States
• Duke University Medical Center — Durham, North Carolina, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Baylor College of Medicine — Houston, Texas, United States
• Latter Day Saints Hospital — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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