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

Phase 2

Completed

• Conditions: Pulmonary Arterial Hypertension; Ayerza Syndrome; Pulmonary Hypertension

• Registration Number: NCT00086463
• Lead Sponsor: Actelion

Brief Summary

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).

Detailed Description

This is a randomized, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) with an NYHA Class of III or IV who are receiving conventional therapy and bosentan. Subjects who fulfill the inclusion and exclusion criteria will be randomized to study drug (active or placebo) at a frequency of 6-9 inhalations per day for 12 weeks and will continue conventional therapy and bosentan. At the end of the double-blind phase study, open label Iloprost will be provided.

Study Timeline

• Study Start: 2004-06
• Study First Submitted: 2004-07-01
• Study First Submitted QC: 2004-07-02
• Study First Posted: 2004-07-05
• Primary Completion: 2006-01
• Study Completion: 2006-01
• Status Verified: 2011-03
• Last Update Submitted: 2011-03-31
• Last Update Posted: 2011-04-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• 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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Trial Locations

Locations (17)

UCSD Medical Center; 🇺🇸 La Jolla, California, United States

Stanford University Medical Center; 🇺🇸 Palo Alto, California, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of Colorado HSC; 🇺🇸 Denver, Colorado, United States

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States

Rush Heart Institute, Center for Pulmonary Heart Disease; 🇺🇸 Chicago, Illinois, United States

Harbor-UCLA Medical Center; 🇺🇸 Torrance, California, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

The Children's Hospital; 🇺🇸 Denver, Colorado, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

UCSF Medical Center; 🇺🇸 San Francisco, California, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

Latter Day Saints Hospital; 🇺🇸 Salt Lake City, Utah, United States