Status:
WITHDRAWN
Safety and Efficacy of Inhaled Iloprost in Pediatric Patients With Pulmonary Arterial Hypertension
Lead Sponsor:
Actelion
Conditions:
Pulmonary Arterial Hypertension
Eligibility:
All Genders
3-18 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of iloprost for PAH in children who are between the ages of 3 and 18 years old.
Eligibility Criteria
Inclusion
- Male or female, age 3-18 years
- Diagnosis of PAH due to IPAH, connective tissue disease, or congenital heart disease
- Pulmonary arterial hypertension confirmed by a cardiac catheterization, with mPAP \> 25 mmHg at rest, PCWP or LVEDP ≤ 15 mmHg, and PVR ≥ 240 dynes/sec/cm-5 (ie, ≥ 3.0 units m2)
- NYHA/WHO functional Class II, III, or IV
- Have had a 6-minute walk test (6-MWT) performed within the 3 months preceding the screening visit (if ≥ 8 years of age)
- Have had cardiopulmonary exercise testing (CPET) performed within the 3 months preceding the screening visit (if ≥ 8 years of age and \> 130 cms in height. CPET testing will be conducted on NYHA/WHO Class IV patients at the discretion of the Principal Investigator)
- If receiving therapy for PAH, on a stable dose and regimen for at least 3 months prior to the screening visit
- If receiving digoxin, diuretic, or oxygen therapy, on a stable dose and regimen for at least 30 days preceding the screening visit
- Must demonstrate the ability to appropriately use the nebulizer device as part of the screening process
Exclusion
- Prior use of prostacyclins or prostacyclin analogues within 3 months prior to screening
- Portal hypertension or clinically relevant hepatic disease
- Eisenmenger syndrome with resting SpO2 \<88% on room air
- Clinically relevant asthma or other chronic lung disease, such as bronchopulmonary dysplasia, cystic fibrosis, or repaired or unrepaired congenital diaphragmatic hernia
- Diagnosis or current evidence of active lung infection or clinically relevant hemoptysis
- Left-sided heart disease, including valvular disease or heart failure
- Initiation or dosage adjustment of PAH-specific therapy within 3 months prior to screening
- Initiation of treatment with digoxin, diuretics, anticoagulation, or oxygen therapy within 30 days prior to screening
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2006
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00453414
Start Date
July 1 2006
End Date
October 1 2006
Last Update
February 15 2010
Active Locations (2)
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1
The Children's Hospital
Denver, Colorado, United States, 80218
2
Columbia University Medical Center
New York, New York, United States, 10032