The "Power 15 Study": Safety Study of Inhalation of Ventavis With the Power Disc-15 Setting
NCT ID: NCT00467896
Last Updated: 2013-04-04
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
62 participants
INTERVENTIONAL
2006-09-30
2011-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Iloprost
The study enrolled patients who were already using iloprost (10 µg/mL) standard dose (5 µg) delivered by I-neb® Adaptive Aerosol Delivery (AAD) System with Power Disc-6 (PD-6) without any safety or tolerability concerns, thereby facilitating a direct comparison with the Power Disc-15 (PD-15). The single arm design allowed each patient to serve as his/her own control.
Iloprost PD-6
Period I: Patients received iloprost administered using PD-6 for the 37 days prior to the first dosing of iloprost using PD-15. Iloprost inhalation solution was delivered using the I-neb® AAD System. Patients were required to use their own I-neb®.
Iloprost PD-15
Period II: Iloprost inhalation solution was delivered using the investigational product PD-15 with I-neb® AAD System for 37 days. Patients were required to use their own I-neb®.
Interventions
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Iloprost PD-6
Period I: Patients received iloprost administered using PD-6 for the 37 days prior to the first dosing of iloprost using PD-15. Iloprost inhalation solution was delivered using the I-neb® AAD System. Patients were required to use their own I-neb®.
Iloprost PD-15
Period II: Iloprost inhalation solution was delivered using the investigational product PD-15 with I-neb® AAD System for 37 days. Patients were required to use their own I-neb®.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Have a current diagnosis of symptomatic pulmonary arterial hypertension (PAH) classified by one of the following: a) idiopathic pulmonary arterial hypertension (IPAH) or familial pulmonary arterial hypertension (FPAH); b) PAH associated with one of the following connective tissue diseases and mild or no lung parenchymal disease: scleroderma spectrum of disease, systemic lupus erythematosis, or mixed connective tissue disease, c) PAH associated with repaired atrial septal defect (ASD), ventricular septal defect (VSD), or patent ductus arteriosis (PDA) ≥ 1 year post-operative from Screening, d) PAH associated with human immunodeficiency virus (HIV), or e) PAH associated with the use of anorexigens (e.g. fenfluramine-phentermine)
* On a stable and well tolerated dose regimen of Ventavis (5 μg per dose) for at least 4 weeks prior to the Screening visit, using the I-neb AAD System equipped with Power Disc-6
Exclusion Criteria
* Receipt of atrial septostomy within the 6 months preceding Screening
* History of left-sided heart disease
* Clinically relevant obstructive lung disease
* Chronic renal or liver disease
* Uncontrolled systemic hypertension or hypotension
* Cerebrovascular event within the 6 months preceding Screening
18 Years
85 Years
ALL
No
Sponsors
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Actelion
INDUSTRY
Responsible Party
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Principal Investigators
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Michael A Mathier, MD
Role: PRINCIPAL_INVESTIGATOR
University of Pittsburgh Medical Center
Ramagopal Tumuluri, MD
Role: PRINCIPAL_INVESTIGATOR
Aurora Medical Group - Cardiovascular Services
Charles J. Burch, MD
Role: PRINCIPAL_INVESTIGATOR
Diagnostic Research Group
David Baratz, MD
Role: PRINCIPAL_INVESTIGATOR
Pulmonary Associates
Ben DeBoisblanc, MD
Role: PRINCIPAL_INVESTIGATOR
Ochsner Health System
Adaani Frost, MD
Role: PRINCIPAL_INVESTIGATOR
Baylor College of Medicine
Victor Test, MD
Role: PRINCIPAL_INVESTIGATOR
UCSD Medical Center, Thorton Hospital
Sif Handsdottir, MD
Role: PRINCIPAL_INVESTIGATOR
University of Iowa Hospital & Clinics
Myung Park, MD
Role: PRINCIPAL_INVESTIGATOR
University of Maryland Hospital
Evelyn Horn, MD
Role: PRINCIPAL_INVESTIGATOR
New York Presbyterian Hospital
Erika Berman-Rosenzweig, MD
Role: PRINCIPAL_INVESTIGATOR
Columbia University
Victor Tapson, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Pulmonary Associates
Phoenix, Arizona, United States
UCSD Medical Center, Thorton Hospital
La Jolla, California, United States
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
University of Maryland Hospital
Baltimore, Maryland, United States
Columbia University Medical Center
New York, New York, United States
New York Presbyterian Hospital
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Baylor College of Medicine
Houston, Texas, United States
Diagnostic Research Group
San Antonio, Texas, United States
Aurora Medical Group - Cardiovascular Services
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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C200-008
Identifier Type: -
Identifier Source: org_study_id
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