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Sponsored by: |
Actelion |
Information provided by: | Actelion |
ClinicalTrials.gov Identifier: | NCT00709098 |
Patients with symptomatic idiopathic (IPAH) or familial (FPAH) pulmonary arterial hypertension in NYHA class II to IV currently being treated with a stable dose of either bosentan or sildenafil and who complete PROWESS 15 will be enrolled in the PROWESS 15 Extension study. This is a double-blind (12 week), randomized study to compare the safety and tolerability of inhaled iloprost power disc-15 and power disc-6 in patients with symptomatic PAH. After completion of the double blind period, patients will be entered in the open label period using iloprost power disc-15.
Condition | Intervention | Phase |
Pulmonary Arterial Hypertension |
Drug: iloprost |
Phase III |
Genetics Home Reference related topics: | pulmonary arterial hypertension |
MedlinePlus related topics: | High Blood Pressure |
Drug Information available for: | Iloprost |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Crossover Assignment, Safety Study |
Official Title: | A Multicenter, Double-Blind, Randomized Study Comparing the Safety and Tolerability of Iloprost Inhalation Solution Delivered by I-Neb Utilizing Power Disc-15 and Power Disc-6 in Patients With Symptomatic Pulmonary Arterial Hypertension |
Estimated Enrollment: | 63 |
Study Start Date: | June 2008 |
Estimated Study Completion Date: | February 2009 |
Estimated Primary Completion Date: | February 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
1: Experimental
iloprost power 15
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Drug: iloprost
Iloprost 5 mcg delivered by I-neb(R)AAD(R) System power disc-15 administered 6 to 9 times per day for 12 weeks. If patient enters open label follow-up period, iloprost 5 mcg delivered by I-neb(R)AAD(R) System power disc-15 administered 6 to 9 times per day until the end of study.
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2: Active Comparator
iloprost power 6
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Drug: iloprost
Iloprost 5 mcg delivered by I-neb(R)AAD(R) System power disc-6 administered 6 to 9 times per day for 12 weeks. If patient enters open label follow-up period, iloprost 5 mcg delivered by I-neb(R)AAD(R) System power disc-15 administered 6 to 9 times per day until the end of study.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, California | |||||
UCSD Medical Center | |||||
La Jolla, California, United States, 92037 | |||||
Liu Center for Pulmonary Hypertension - LA Biomedical Research Institute at Harbor-UCLA | |||||
Torrance, California, United States, 90502 | |||||
United States, Iowa | |||||
University of Iowa Hospitals and Clinics | |||||
Iowa City, Iowa, United States, 52242 | |||||
United States, Kentucky | |||||
Kentuckiana Pulmonary Associates | |||||
Louisville, Kentucky, United States, 40202 | |||||
United States, Louisiana | |||||
LSU Health Sciences Center | |||||
New Orleans, Louisiana, United States, 70112 | |||||
United States, Maryland | |||||
University of Maryland Medical Center | |||||
Baltimore, Maryland, United States, 21201 | |||||
United States, Nebraska | |||||
University of Nebraska Medical Center | |||||
Omaha, Nebraska, United States, 68198 | |||||
United States, New Jersey | |||||
Newark Beth Israel Medical Center | |||||
Newark, New Jersey, United States, 07112 | |||||
United States, New York | |||||
Winthrop University Hospital | |||||
Mineola, New York, United States, 11501 | |||||
United States, Ohio | |||||
The Ohio State University Medical Center | |||||
Columbus, Ohio, United States, 43221 | |||||
The Lindner Clinical Trial Center | |||||
Cincinnati, Ohio, United States, 45219 | |||||
United States, Oregon | |||||
Legacy Health System | |||||
Portland, Oregon, United States, 97210 | |||||
United States, Pennsylvania | |||||
Temple University Hospital | |||||
Philadelphia, Pennsylvania, United States, 19140 | |||||
United States, Rhode Island | |||||
Rhode Island Hospital | |||||
Providence, Rhode Island, United States, 02903 | |||||
United States, Utah | |||||
Intermountain Medical Center | |||||
Murray, Utah, United States, 84157 | |||||
United States, Virginia | |||||
University of Virginia | |||||
Charlottesville, Virginia, United States, 22908 | |||||
United States, Wisconsin | |||||
Comprehensive Cardiovascular Care LLP | |||||
Milwaukee, Wisconsin, United States, 53215 |
Actelion |
Study Director: | Laila Rouault, MD | Actelion |
Responsible Party: | Actelion ( Laila Rouault, MD ) |
Study ID Numbers: | AC-063A302 |
First Received: | July 1, 2008 |
Last Updated: | September 29, 2008 |
ClinicalTrials.gov Identifier: | NCT00709098 |
Health Authority: | United States: Food and Drug Administration |
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