A Safety and Pilot Efficacy Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With PAH
Data Collection
Pulmonary Arterial Hypertension+5
+ Cardiovascular Diseases
+ Hypertension
Treatment Study
Summary
Study start date: June 1, 2004
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.60 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 12 to 75 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
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 Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 17 locations
UCSD Medical Center
La Jolla, United StatesStanford University Medical Center
Palo Alto, United StatesUCSF Medical Center
San Francisco, United States