Safety Evaluation of Inhaled Treprostinil Administration Following Transition From Inhaled Ventavis in Pulmonary Arterial Hypertension (PAH) Subjects
NCT ID: NCT00741819
Last Updated: 2013-02-20
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
73 participants
INTERVENTIONAL
2008-09-30
2010-12-31
Brief Summary
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Subjects are to be evaluated for safety throughout the course of the study while secondary assessments will be conducted at Baseline, Week 6, Week 12, and Months 6, 12, 18 and 24 following initiation of treprostinil sodium.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Inhaled treprostinil
Solution for oral inhalation treprostinil (0.6 mg/mL). Inhaled via an ultrasonic nebulizer which provides a dose of 6mcg of treprostinil per breath. Doses are titrated up to 12 breaths four times daily.
Inhaled treprostinil
Interventions
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Inhaled treprostinil
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* PAH diagnosis defined by following WHO Group I categories: idiopathic/familial, associated with unrepaired or repaired congenital systemic-to-pulmonary shunts (repaired \>/= 5 years), associated with collagen vascular disease, associated with HIV, associated with appetite suppressant/toxin use
* Baseline six-minute walk distance (6MWD) \>/= 250 meters
* Currently receiving Ventavis and be stable at current dose for 30 days prior to Baseline
* If currently receiving other approved background therapy (i.e. endothelin receptor antagonist or phosphodiesterase-5-inhibitor or both) must be on stable dose for 30 days prior to Baseline
* Previous testing (e.g. right heart catheterization, echocardiography) consistent with diagnosis of PAH
* History of uncontrolled sleep apnea, left-sided heart disease, or parenchymal lung disease
* Use of investigational drug within 30 days of Baseline
Exclusion Criteria
18 Years
75 Years
ALL
No
Sponsors
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United Therapeutics
INDUSTRY
Responsible Party
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Locations
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University of Alabama Birmingham
Birmingham, Alabama, United States
UCSD Medical Center
La Jolla, California, United States
Ronald Reagan UCLA Medical Center
Los Angeles, California, United States
Kansas University Medical Center
Kansas City, Kansas, United States
Long Island Jewish Medical Center - North Shore
New Hyde Park, New York, United States
Beth Israel Medical Center
New York, New York, United States
Cornell University Medical Center
New York, New York, United States
Columbia Presbyterian Medical Center
New York, New York, United States
Mary M. Parkes Center for Asthma, Allergy and Pulmonary Care
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Ohio State University Medical Center
Columbus, Ohio, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburg Medical Center
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
Countries
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Other Identifiers
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RIN-PH-401
Identifier Type: -
Identifier Source: org_study_id
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