Clinical Investigation Into Inhaled Treprostinil Sodium in Patients With Severe Pulmonary Arterial Hypertension (PAH)
NCT ID: NCT00147199
Last Updated: 2024-01-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
235 participants
INTERVENTIONAL
2005-06-30
2007-10-31
Brief Summary
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Detailed Description
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Administration of study medication was performed by inhalation with the OPTINEB™ ultrasonic nebulizer.
The proposed dosing regimen was four times daily-upon awakening, at midday, evening (dinner time) and bedtime.
After a patient has completed the twelve-week study period, they were given the option of enrolling into an open-label extension study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Inhaled treprostinil
0.9 mg/mL treprostinil for inhalation supplied in 2.9mL ampoules for use in ultra sonic nebulizer
Inhaled treprostinil
Doses are titrated to 9 breaths four times daily. Each breath produces an 18 mcg dose of inhaled treprostinil.
Placebo
Placebo inhalation solution for use in ultrasonic nebulizer
Placebo inhalation solution
Doses are titrated to 9 breaths four times daily.
Interventions
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Inhaled treprostinil
Doses are titrated to 9 breaths four times daily. Each breath produces an 18 mcg dose of inhaled treprostinil.
Placebo inhalation solution
Doses are titrated to 9 breaths four times daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Been on a stable dose of 125 mg twice daily (bid) of bosentan OR any stable dose of sildenafil for at least three months prior to study start
* An unencouraged six minute walk test (6MWT) of between 200 and 450 meters at screening
* Cardiac catheterization within the past 13 months consistent with PAH, specifically mean pulmonary artery pressure (PAPm) ≥25 mmHg (at rest), pulmonary capillary wedge pressure (PCWP) (or left ventricular end diastolic pressure) ≤15 mmHg, and pulmonary vascular resistance (PVR) \>3 mmHg/L/min
* Within the past 12 months, patients must have had a chest radiograph consistent with the diagnosis of PAH
* Willing and able to follow all study procedures
* Have had any change in or discontinued any PAH medication within the last three months, including but not limited to endothelin receptor antagonist (ERA), or calcium channel blockers (CCB) (with the exception of anticoagulants)
* Have received any prostanoid within the 30 days before screening or are scheduled to receive any during the course of the study
* Have received any investigational medication within 30 days prior to the start of this study or are scheduled to receive another investigational drug during the course of this study
* Have a known intolerance to any drug, especially to treprostinil sodium or prostanoids
* Have an increased risk of hemorrhage
* Have a new type of chronic therapy (e.g., a different category of vasodilator, diuretic) for PAH added within the last month, except anticoagulants
* Have any musculoskeletal disease or any other disease that would limit ambulation.
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, Alabama, United States
University of Arizona
Tucson, Arizona, United States
UCSD Medical center
La Jolla, California, United States
UCLA Medical Center
Torrance, California, United States
University of Colorado
Aurora, Colorado, United States
Orlando Heart Center
Orlando, Florida, United States
Kansas University Medical Center
Kansas City, Kansas, United States
Johns Hopkins University
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Bethe Israel Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
UTSW Medical Center
Dallas, Texas, United States
Universitatsklinikfur Innere Medizin II
Wein, Vienna, Austria
Medical University Graz
Graz, , Austria
Universite Libre de Bruxelles
Brussels, , Belgium
University Hospital Gasthuisburg
Leuven, , Belgium
Hospital Antoine Beclere
Paris, , France
Univesitatsklinikum Giessen und Marburg GmbH
Geißen, , Germany
Pulmonary Hypertension Unit
Dublin, , Ireland
Rambam Medical Center
Haifa, , Israel
The Pulmonary Institute
Jerusalem, , Israel
The Pulmonary Institute
Petach Tikvah 49100, , Israel
Instituto Malattie dell'Apparato Vascolare
Bologna, , Italy
University of Barcelona
Barcelona, , Spain
Papworth Hospital
Cambridge, , United Kingdom
Scottish Pulmonary Vascular Unit
Glasgow GII 6NT, , United Kingdom
Royal Fee Hospital
London, , United Kingdom
Countries
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References
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McLaughlin VV, Benza RL, Rubin LJ, Channick RN, Voswinckel R, Tapson VF, Robbins IM, Olschewski H, Rubenfire M, Seeger W. Addition of inhaled treprostinil to oral therapy for pulmonary arterial hypertension: a randomized controlled clinical trial. J Am Coll Cardiol. 2010 May 4;55(18):1915-22. doi: 10.1016/j.jacc.2010.01.027.
Related Links
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The mission of the Pulmonary Hypertension Association is to seek a cure, and to provide hope, support and education, and to promote awareness and to advocate for the pulmonary hypertension community.
Other Identifiers
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LRX-TRIUMPH 001
Identifier Type: -
Identifier Source: org_study_id
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