Status:
COMPLETED
Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With Pulmonary Arterial Hypertension (PAH)
Lead Sponsor:
Actelion
Conditions:
Pulmonary Arterial Hypertension
Ayerza Syndrome
Eligibility:
All Genders
12-75 years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2004
Trial Type :
INTERVENTIONAL
End Date :
January 1 2006
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT00086463
Start Date
June 1 2004
End Date
January 1 2006
Last Update
April 1 2011
Active Locations (17)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
UCSD Medical Center
La Jolla, California, United States, 92037
3
Stanford University Medical Center
Palo Alto, California, United States, 94305
4
UCSF Medical Center
San Francisco, California, United States, 94143