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

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ClinicalTrials.gov Identifier: NCT00453414
Recruitment Status : Withdrawn (Withdrawn due to lack of enrollment)
First Posted : March 29, 2007
Last Update Posted : February 15, 2010
Sponsor:
Information provided by:
Actelion

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.

Condition or disease Intervention/treatment Phase
Pulmonary Arterial Hypertension Drug: Iloprost Inhalation Solution (Ventavis) Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Inhaled Iloprost in Pediatric Patients With Pulmonary Arterial Hypertension
Study Start Date : July 2006
Estimated Primary Completion Date : October 2006
Estimated Study Completion Date : October 2006





Primary Outcome Measures :
  1. Change from baseline in 6-minute walk distance measured post-inhalation (for patients ≥ 8 years old) at Week 8 and Week 16
  2. Change from baseline in Borg Dyspnea Scale measured following 6-MWT (for patients ≥ 8 years old) at Week 8 and Week 16
  3. Change from baseline in NYHA/WHO functional class at Week 8 and Week 16
  4. 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
  5. 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
  6. Change from baseline in Child Health Questionnaire (CHQ-28) at Week 8 and Week 16
  7. 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


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Ages Eligible for Study:   3 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

ClinicalTrials.gov Identifier: NCT00453414     History of Changes
Other Study ID Numbers: C200-007
First Posted: March 29, 2007    Key Record Dates
Last Update Posted: February 15, 2010
Last Verified: February 2010

Keywords provided by Actelion:
PAH
Pediatric
Pulmonary Arterial Hypertension

Additional relevant MeSH terms:
Hypertension
Familial Primary Pulmonary Hypertension
Vascular Diseases
Cardiovascular Diseases
Hypertension, Pulmonary
Lung Diseases
Respiratory Tract Diseases
Iloprost
Platelet Aggregation Inhibitors
Vasodilator Agents