Safety and Efficacy of Inhaled Iloprost in Pediatric Patients With Pulmonary Arterial Hypertension

• Status: Withdrawn
• Trial end date: 2006-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Actelion
• Treatments: Iloprost

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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