Status:
TERMINATED
The "Power 15 Study": Safety Study of Inhalation of Ventavis With the Power Disc-15 Setting
Lead Sponsor:
Actelion
Conditions:
Pulmonary Hypertension
Eligibility:
All Genders
18-85 years
Phase:
PHASE2
Brief Summary
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"
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2011
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00467896
Start Date
September 1 2006
End Date
June 1 2011
Last Update
April 4 2013
Active Locations (12)
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1
Pulmonary Associates
Phoenix, Arizona, United States, 85006
2
UCSD Medical Center, Thorton Hospital
La Jolla, California, United States, 92037
3
University of Iowa Hospital and Clinics
Iowa City, Iowa, United States, 52242
4
Ochsner Clinic Foundation
New Orleans, Louisiana, United States, 70112