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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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

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.

Detailed Summary:
Sponsor: Actelion

Current Primary Outcome:

  • Change from baseline in 6-minute walk distance measured post-inhalation (for patients ≥ 8 years old) at Week 8 and Week 16
  • Change from baseline in Borg Dyspnea Scale measured following 6-MWT (for patients ≥ 8 years old) at Week 8 and Week 16
  • Change from baseline in NYHA/WHO functional class at Week 8 and Week 16
  • Change from baseline in hemodynamic parameters measured at Week 16, and in patients who are able to undergo iloprost inhalation while consciously sedated, hemodynamic parameters measured prior to dosing and 15-30 minutes after dosing
  • Time to clinical worsening, defined as any one of the following: death due to underlying PAH, transplantation, atrial septostomy, hospitalization for PAH or right heart failure, >15% worsening in 6-minute walk distance in concert with a ≥ 1 class deteri
  • Change from baseline in Child Health Questionnaire (CHQ-28) at Week 8 and Week 16
  • Change from baseline in exercise capacity, as measured by post-inhalation CPET, at Week 8 and Week 16 (if ≥ 8 years old and > 130 cms in height. CPET testing will be conducted on NYHA/WHO Class IV patients at the discretion of the Principal Investigat


Original Primary Outcome:

  • Change from baseline in 6-minute walk distance measured post-inhalation (for patients ≥ 8 years old) at Week 8 and Week 16
  • Change from baseline in Borg Dyspnea Scale measured following 6-MWT (for patients ≥ 8 years old) at Week 8 and Week 16
  • Change from baseline in NYHA/WHO functional class at Week 8 and Week 16
  • Change from baseline in hemodynamic parameters measured at Week 16, and in patients who are able to undergo iloprost inhalation while consciously sedated, hemodynamic parameters measured prior to dosing and 15-30 minutes after dosing
  • Time to clinical worsening, defined as any one of the following: death due to underlying PAH, transplantation, atrial septostomy, hospitalization for PAH or right heart failure, >15% worsening in 6-minute walk distance in concert with a ≥ 1 class deteri
  • Change from baseline in Child Health Questionnaire (CHQ-28) at Week 8 and Week 16
  • Change from baseline in exercise capacity, as measured by post-inhalation CPET, at Week 8 and Week 16 (if  8 years old and > 130 cms in height. CPET testing will be conducted on NYHA/WHO Class IV patients at the discretion of the Principal Investigat


Current Secondary Outcome:

Original Secondary Outcome:

Information By: Actelion

Dates:
Date Received: March 27, 2007
Date Started: July 2006
Date Completion: October 2006
Last Updated: February 12, 2010
Last Verified: February 2010