Iloprost Inhalation Solution (Ventavis) in Pulmonary Arterial Hypertension - Clinical Trials Registry

Study Overview

Status

Withdrawn

Conditions

Pulmonary Arterial Hypertension

Intervention / Treatment

Drug: Iloprost Inhalation Solution (Ventavis)

Study Type

Interventional

Phase

Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Colorado
  - Denver, Colorado, United States, 80218
    - The Children's Hospital
- New York
  - New York, New York, United States, 10032
    - Columbia University Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Actelion

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2006

Primary Completion (Anticipated)

October 1, 2006

Study Completion (Anticipated)

October 1, 2006

Study Registration Dates

First Submitted

March 27, 2007

First Submitted That Met QC Criteria