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Safety and Efficacy of Inhaled Iloprost in Pediatric Patients With Pulmonary Arterial Hypertension | Clinical Trials | Clareo Health

WITHDRAWNPHASE2

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

NCT00453414•Actelion

View on ClinicalTrials.gov

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

Age

3 - 18 years

Sex

ALL

Healthy Volunteers

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

Locations (2)

The Children's Hospital

Denver, Colorado, United States

Columbia University Medical Center

New York, New York, United States

Key Dates

Start Date

July 1, 2006

Primary Completion Date

October 1, 2006

Completion Date

October 1, 2006

Last Updated

February 15, 2010

Conditions

Pulmonary Arterial Hypertension

Interventions

Iloprost Inhalation Solution (Ventavis)

DRUG

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

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RECRUITINGPHASE3

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

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RECRUITINGPHASE1

A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 15, 2010Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Study to Learn About the Treatment LTP001 in Healthy Participants (Part A) and in Participants With PAH (Part B)

A Clinical Study of Sotatercept (MK-7962) in People With Pulmonary Arterial Hypertension (MK-7962-038)

A Placebo-controlled, Randomized Clinical Trial to Assess the Safety, Feasibility, and Pharmacokinetics of Microbiota Transplant Therapy With Antibiotic Preconditioning and Fiber Supplementation in Patients With Pulmonary Arterial Hypertension

COMPERA / COMPERA-KIDS

The MObile Health InterVEntion in Pulmonary Arterial Hypertension (MOVE PAH) Study

China Pulmonary Vascular Disease Intervention Diagnosis and Management Study-right Heart Catheterization