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The "Power 15 Study": Safety Study of Inhalation of Ventavis With the Power Disc 15 Setting
This study is currently recruiting participants.
Verified by Actelion, April 2009
First Received: April 27, 2007   Last Updated: April 27, 2009   History of Changes
Sponsored by: Actelion
Information provided by: Actelion
ClinicalTrials.gov Identifier: NCT00467896
  Purpose

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"


Condition Phase
Pulmonary Hypertension
Phase II

MedlinePlus related topics: High Blood Pressure Pulmonary Hypertension
Drug Information available for: Iloprost
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Retrospective
Official Title: 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"

Further study details as provided by Actelion:

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

Estimated Enrollment: 80
Study Start Date: September 2006
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients satisfying the eligibility criteria, have at least 32 consecutive days of inhalation times data during period one (baseline), and have at least 6 consecutive days of inhalation time data after beginning period two (active), will be included in the analysis for evaluating improvements in inhalation times associated with use of PD-15. Patients who have a change (dosing change,new medication or elimination of a medication) in their PAH medications during period two, will have their data truncated at the time of the first change in medication. Patients who do not follow the prescribing and patient information labeling for Ventavis during period two will be excluded.

Criteria

Inclusion Criteria:

  • Male or female, aged 18-85 years
  • Have a current diagnosis of symptomatic PAH classified by one of the following: a) IPAH or 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 arteriosus (PDA) ≥ 1 year post-operative from Screening, d) PAH associated with 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 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00467896

Contacts
Contact: Sandy Petersen, MS 650-243-2359 sandy.petersen@actelion.com
Contact: Kathleen Feldkircher 650-243-2345 kathleen.feldkircher@actelion.com

Locations
United States, Arizona
Pulmonary Associates Recruiting
Phoenix, Arizona, United States, 85006
Contact: Liyi Fu, MD     602-258-4951     palyf@aol.com    
Principal Investigator: David Baratz, MD            
United States, Louisiana
Louisiana State University Health Sciences Center Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Paula Lauto, RN, BSN     504-568-3451     plauto@lsuhsc.edu    
Principal Investigator: Ben DeBoisblanc, MD            
United States, Pennsylvania
University of Pittsburgh Medical Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Allison Thompson, BS     412-647-2820     thompsonac2@upmc.edu    
Contact: Kirsten Schwoegl     412-647-5363     schwoeglk@upmc.edu    
Principal Investigator: Michael A Mathier, MD            
United States, Texas
Diagnositc Research Group Recruiting
San Antonio, Texas, United States, 78229
Contact: Kathy Canty, RN, BSN     210-692-7157     kcanty@drxg.com    
Principal Investigator: Charles J Burch, MD            
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Royanne Holy     713-798-2684     rholy@bcm.edu    
Principal Investigator: Adaani Frost, MD            
United States, Wisconsin
Heart Care Associates Recruiting
Milwaukee, Wisconsin, United States, 53215
Contact: Don Lobacz     414-649-3438     dlobacz@hrtcare.com    
Principal Investigator: Ramagopal Tumuluri, MD            
Sponsors and Collaborators
Actelion
Investigators
Principal Investigator: Michael A Mathier, MD University of Pittsburgh
Principal Investigator: Ramagopal Tumuluri, MD Heart Care Associates, LLC
Principal Investigator: Charles J. Burch, MD Diagnostics Research Group
Principal Investigator: David Baratz, MD Pulmonary Associates
Principal Investigator: Ben DeBoisblanc, MD Louisiana State University Health Sciences Center
Principal Investigator: Adaani Frost, MD Baylor College of Medicine
  More Information

No publications provided

Responsible Party: Actelion Pharmaceuticals, US, Inc. ( Actelion )
Study ID Numbers: C200-008
Study First Received: April 27, 2007
Last Updated: April 27, 2009
ClinicalTrials.gov Identifier: NCT00467896     History of Changes
Health Authority: United States: Food and Drug Administration

Keywords provided by Actelion:
PAH
iloprost
Ventavis
Pulmonary Arterial Hypertension
Actelion Pharmaceuticals
Cotherix

Study placed in the following topic categories:
Iloprost
Vasodilator Agents
Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases
Idiopathic Pulmonary Hypertension
Vascular Diseases
Platelet Aggregation Inhibitors
Cardiovascular Agents
Hypertension

Additional relevant MeSH terms:
Vasodilator Agents
Hematologic Agents
Vascular Diseases
Cardiovascular Agents
Pharmacologic Actions
Iloprost
Respiratory Tract Diseases
Hypertension, Pulmonary
Lung Diseases
Therapeutic Uses
Cardiovascular Diseases
Platelet Aggregation Inhibitors
Hypertension

ClinicalTrials.gov processed this record on May 07, 2009