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

This study has been withdrawn prior to enrollment.
(Withdrawn due to lack of enrollment)
Sponsor:
Information provided by:
Actelion
ClinicalTrials.gov Identifier:
NCT00453414
First received: March 27, 2007
Last updated: February 12, 2010
Last verified: February 2010
  Purpose

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.


Condition Intervention Phase
Pulmonary Arterial Hypertension
Drug: Iloprost Inhalation Solution (Ventavis)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Inhaled Iloprost in Pediatric Patients With Pulmonary Arterial Hypertension

Resource links provided by NLM:


Further study details as provided by Actelion:

Primary Outcome Measures:
  • 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 [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: July 2006
Estimated Study Completion Date: October 2006
Estimated Primary Completion Date: October 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   3 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00453414

Locations
United States, Colorado
The Children's Hospital
Denver, Colorado, United States, 80218
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Sponsors and Collaborators
Actelion
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00453414     History of Changes
Other Study ID Numbers: C200-007
Study First Received: March 27, 2007
Last Updated: February 12, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Actelion:
PAH
Pediatric
Pulmonary Arterial Hypertension

Additional relevant MeSH terms:
Hypertension
Hypertension, Pulmonary
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Vascular Diseases
Iloprost
Cardiovascular Agents
Hematologic Agents
Pharmacologic Actions
Platelet Aggregation Inhibitors
Therapeutic Uses
Vasodilator Agents

ClinicalTrials.gov processed this record on November 27, 2014