The "Power 15 Study": Safety Study of Inhalation of Ventavis With the Power Disc-15 Setting

Stopped early · Phase 2

Conditions studied: Pulmonary Hypertension

In brief

A Comparison of Safety and Inhalation Times of Ventavis (iloprost) Inhalation Solution delivered by I-Neb Utilizing Power Disc-6 and Power Disc-15 "Power 15 Study"

Key facts

Study ID

NCT00467896

Run by

Actelion

People needed

62

Starts

2006-09-01

Expected to finish

2011-06-01

Last updated by the study team

2013-04-04

Who can join

Age: 18 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female, aged 18-85 years
• 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

You may not qualify if…

• Receipt of any prostacyclin or prostacyclin analogue other than Ventavis within the 12 weeks preceding the Screening visit
• 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

Where it is running

• 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

Full record on ClinicalTrials.gov

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