ARTEMIS-PH - Study of Ambrisentan in Subjects With Pulmonary Hypertension Associated With Idiopathic Pulmonary Fibrosis
NCT ID: NCT00879229
Last Updated: 2014-05-15
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
40 participants
INTERVENTIONAL
2009-07-31
2011-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ambrisentan
Participants were randomized to receive ambrisentan treatment at an initial dose of 5 mg for 4 weeks, followed by ambrisentan at the target dose of 10 mg for an additional 52 weeks
Ambrisentan
Ambrisentan (5 mg or 10 mg tablet) administered orally once daily.
Placebo
Participants were randomized to receive placebo to match ambrisentan for 48 weeks, then transition to ambrisentan treatment at the initial dose of 5 mg for 4 weeks, followed by ambrisentan at the target dose of 10 mg for an additional 4 weeks.
Ambrisentan
Ambrisentan (5 mg or 10 mg tablet) administered orally once daily.
Placebo
Placebo to match ambrisentan administered orally once daily.
Interventions
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Ambrisentan
Ambrisentan (5 mg or 10 mg tablet) administered orally once daily.
Placebo
Placebo to match ambrisentan administered orally once daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of IPF based on modified American Thoracic Society-European Respiratory Society guidelines
* Diagnosis of PH based on the following hemodynamic requirements: mean pulmonary artery pressure (mPAP ≥ 25 mm Hg; pulmonary vascular resistance \> 240 dyne.sec/cm\^5; pulmonary capillary wedge pressure or left ventricular end-diastolic pressure ≤ 15 mm Hg
* Forced vital capacity (FVC) ≥ 40%
* Able to walk at least 50 meters during two 6-minute walk tests
* If receiving calcium channel blockers, low-dose oral corticosteroids, immunosuppressive, cytoxic, or antifibrotic drugs dose must have been stable.
Exclusion Criteria
* Surgical lung biopsy diagnosis other than Usual Interstitial Pneumonia
* Other known cause of interstitial lung disease
* Evidence of significant obstructive lung disease
* Recent hospitalization for an acute exacerbation of IPF
* Recent active pulmonary or upper respiratory tract infection
* Left ventricular ejection fraction \< 40%
* Serum creatinine ≥ 2.5 mg/dL
* Required hemodialysis, peritoneal dialysis, or hemofiltration
* Female subject who was pregnant or breastfeeding
* Recent treatment for PH with an endothelin receptor antagonist (ERA), phosphodiesterase type 5 inhibitor, or prostacyclin derivative
* Recent treatment with high dose oral corticosteroids
* Recent treatment (within 4 weeks prior to screening) with imatinib mesylate (Gleevec)
* Alanine aminotransferase or aspartate aminotransferase lab value that was greater than 1.5 x the upper limit of the normal range
* Discontinued other ERA treatment for any adverse reaction other than those associated with liver function test abnormalities
35 Years
80 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Hunter Gillies, M.D.
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Mayo Clinic Arizona
Scottsdale, Arizona, United States
University of California Davis
Davis, California, United States
David Geffen School of Medicine UCLA
Los Angeles, California, United States
University of California San Diego Medical Center
San Diego, California, United States
University of California at San Francisco
San Francisco, California, United States
Stanford University
Stanford, California, United States
University of Colorado Heatlh Sciences Center
Aurora, Colorado, United States
Bay Area Chest Physicians
Clearwater, Florida, United States
University of Florida
Gainesville, Florida, United States
University of Miami Medical Center
Miami, Florida, United States
Suncoast Lung Center
Sarasota, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Atlanta Institute for Medical Research
Decatur, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Kentuckiana Pulmonary Association
Louisville, Kentucky, United States
Maine Medical Center
Portland, Maine, United States
Johns Hopkins University School of Medicine
Baltimore, Maryland, United States
Tufts Medical Center
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Boston University Medical Center
Boston, Massachusetts, United States
Beth Israel Deacones Medical Center
Boston, Massachusetts, United States
University of Michigan Health Systems
Ann Arbor, Michigan, United States
Mayo Clinic Rochester
Rochester, Minnesota, United States
Washington University
St Louis, Missouri, United States
Creighton University Center for Allergy & Asthma
Omaha, Nebraska, United States
Dartmouth Medical School
Lebanon, New Hampshire, United States
Albany Medical Center
Albany, New York, United States
Winthrop University Hospital
Mineola, New York, United States
North Shore Health System
New Hyde Park, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Columbia University
New York, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Duke University Medical Center
Durham, North Carolina, United States
The Lindner Center for Research & Education at The Christ Hospital
Cincinnati, Ohio, United States
University Hospitals of Cleveland Case Western
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, United States
Temple University School of Medicine
Philadelphia, Pennsylvania, United States
Alleghany General Hospital
Pittsburgh, Pennsylvania, United States
University of Pittsburgh Cancer Institute
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
University of Texas Southwestern
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Inova Heart Institiute and Vascular Institute
Falls Church, Virginia, United States
Virginia Commonwealth University Health System
Richmond, Virginia, United States
Providence Everett Medical Center
Everett, Washington, United States
St. Vincents Hospital
Sydney, New South Wales, Australia
The Prince Charles Hospital
Chermside, Queensland, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
Medizinische Universität Graz
Graz, , Austria
Universitatsklinikum Innsbruck
Innsbruck, , Austria
Medizinische Universität Wien
Vienna, , Austria
Peter Loughheed Center- Calgary General Hospital
Calgary, Alberta, Canada
University of British Columbia
Vancouver, British Columbia, Canada
London Health Sciences Centre
London, Ontario, Canada
Toronto General Hospital
Toronto, Ontario, Canada
Centre Hospitalier De L'Universite de Montreal
Montreal, Quebec, Canada
Sir Mortimer B. Davis Jewish General Center
Montreal, Quebec, Canada
Centre de Pneumologie de L'Hospital Laval
Sainte-Foy, Quebec, Canada
Evangelische Lungenklinik Berlin
Berlin, , Germany
Charite-Universitatsmedizin Berlin
Berlin, , Germany
Krankenhaus Donaustauf der LVA
Donaustauf, , Germany
Universitatsklinikum Freiburg
Freiburg im Breisgau, , Germany
Universitat Greifswald
Greifswald, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Thorax Klinik
Heidelberg, , Germany
LMU Klinikum der Universitat
München, , Germany
Azienda Ospedaliero Universitaria
Catania, , Italy
Presidio Ospedaliero G.B. Morgagni
Forlì, , Italy
Ospedale S.Giuseppe Fatebenefratelli
Milan, , Italy
Unita Funzionale di Pneumologia e Fisiopatologia Respiratoria
Milan, , Italy
Azienda Ospedaliera di Padova
Padua, , Italy
Instituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione
Palermo, , Italy
Policlinico Universitario Tor Vergata
Rome, , Italy
Azienda Ospedaliera Universitaria Senese
Siena, , Italy
Centro delle Interstiziopatie Polmonari e Malattie Rare del Polmone
Torino, , Italy
Papworth Hospital NHS Foundation Trust
Cambridge, , United Kingdom
University Hospital Aintree
Liverpool, , United Kingdom
University College Hosptial
London, , United Kingdom
Royal Hallamshire Hospital
Sheffield, , United Kingdom
Countries
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References
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Ruocco G, Cekorja B, Rottoli P, Refini RM, Pellegrini M, Di Tommaso C, Del Castillo G, Franci B, Nuti R, Palazzuoli A. Role of BNP and echo measurement for pulmonary hypertension recognition in patients with interstitial lung disease: An algorithm application model. Respir Med. 2015 Mar;109(3):406-15. doi: 10.1016/j.rmed.2014.12.011. Epub 2015 Jan 3.
Other Identifiers
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GS-US-300-0128
Identifier Type: -
Identifier Source: org_study_id
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