(ARTEMIS-IPF) Randomized, Placebo-Controlled Study to Evaluate Safety and Effectiveness of Ambrisentan in IPF
NCT ID: NCT00768300
Last Updated: 2014-04-08
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
494 participants
INTERVENTIONAL
2008-12-31
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
DOUBLE
Study Groups
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Ambrisentan
Ambrisentan
Ambrisentan (5mg or 10 mg tablet) was administered orally once daily.
Placebo
Placebo
Placebo to match ambrisentan was administered orally once daily.
Interventions
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Ambrisentan
Ambrisentan (5mg or 10 mg tablet) was administered orally once daily.
Placebo
Placebo to match ambrisentan was administered orally once daily.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Diagnosis of IPF
* Honeycombing (fibrosis in the lung) on high-resolution computerised tomography (HRCT) scan of less than or equal to 5%
* Willing and able to have 2 right heart catheterizations performed
* Willing to have monthly lab tests to monitor liver function
* Able to perform the 6 minute walk test (indicated adequate physical function)
* Must have meet lung function requirements
* Normal liver function tests
* Negative serum pregnancy test
* Willing to use at least 2 reliable methods of contraception
* Able to understand and willing to sign informed consent form
Exclusion Criteria
* No obstructive lung disease
* No recent or active respiratory exacerbations
* No recent hospitalization for an IPF exacerbation
* No recent history of alcohol abuse
* Chronic sildenafil (or same drug class) use for pulmonary hypertension
* Chronic treatment with certain medications for IPF within 30 days of randomization
* No other serious medical conditions
40 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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Ganesh Raghu, MD
Role: STUDY_CHAIR
University of Washington, Div. of Pulmonary and Critical Care Medicine Chair
Locations
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University of Alabama at Birmingham Hospital
Birmingham, Alabama, United States
Pulmonary Associates
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
David Geffen School of Medicine at UCLA(Harbor-UCLA Medical Center)
Los Angeles, California, United States
University of California, Davis
Sacramento, California, United States
San Diego, California, United States
San Francisco, California, United States
Stanford University
Stanford, California, United States
National Jewish Medical And Research Center
Denver, Colorado, United States
Newark, Delaware, United States
Bay Area Chest Physicians
Clearwater, Florida, United States
University of Miami Miller School of Medicine
Miami, Florida, United States
Tampa, Florida, United States
Emory University
Atlanta, Georgia, United States
University of Chicago
Chicago, Illinois, United States
Council Bluffs, Iowa, United States
Kentuckiana Pulmonary Association
Louisville, Kentucky, United States
Louisville, Kentucky, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Mayo Clinic
Rochester, Minnesota, United States
Saint Lukes Foundation
Chesterfield, Missouri, United States
Dartmouth Medical School
Lebanon, New Hampshire, United States
New Brunswick, New Jersey, United States
Piscataway, New Jersey, United States
Pulmonary & Allergy Associates
Summit, New Jersey, United States
Pulmonary And Critical Care Services, P.C.
Albany, New York, United States
Winthrop University Hospital
Mineola, New York, United States
New Hyde Park, New York, United States
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Cincinnati, Ohio, United States
The Cleveland Clinic Foundation
Cleveland, Ohio, United States
Columbus, Ohio, United States
The Oregon Clinic, P.C.
Portland, Oregon, United States
University of Pennsylvania Health Systems
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
The Reading Hospital and Medical Center
Reading, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Lexington, South Carolina, United States
Spartanburg, South Carolina, United States
Nashville, Tennessee, United States
Houston, Texas, United States
McKinney, Texas, United States
Provo, Utah, United States
Salt Lake City, Utah, United States
Charlottesville, Virginia, United States
Falls Church, Virginia, United States
Lynchburg, Virginia, United States
Everett, Washington, United States
Seattle, Washington, United States
Mar del Plata, Buenos Aires, Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Buenos Aires, , Argentina
Mar Del Plata, Buenos Aires, , Argentina
San Miguel de Tucumán, , Argentina
Concord, New South Wales, Australia
Darlinghurst, New South Wales, Australia
Chermside, Queensland, Australia
Woodville, South Australia, Australia
Hobart, Tasmania, Australia
Parkville, Victoria, Australia
Prahran, Victoria, Australia
Perth, Western Australia, Australia
Graz, , Austria
Innsbruck, , Austria
Linz, , Austria
Vienna, , Austria
Anderlecht, , Belgium
Brussels, , Belgium
Leuven, , Belgium
Yvoir, , Belgium
São Paulo, São Paulo, Brazil
Belo Horizonte, , Brazil
Florianópolis, , Brazil
Goiânia, , Brazil
Porto Alegre, , Brazil
Porto Alegre, , Brazil
Porto Alegre, , Brazil
Rio de Janeiro, , Brazil
Santo André, , Brazil
Calgary, Alberta, Canada
Edmondton, Alberta, Canada
Vancouver, British Columbia, Canada
Vancouver, British Columbia, Canada
St. John's, Newfoundland and Labrador, Canada
Montreal, Quebec, Canada
Sainte-Foy, Quebec, Canada
Toronto, , Canada
Santiago, , Chile
Talcahuano, , Chile
Valparaíso, , Chile
Bogotá, , Colombia
Floridablanca, , Colombia
Brno, , Czechia
Hradec Králové, , Czechia
Jihlava, , Czechia
Liberec, , Czechia
Olomouc, , Czechia
Pilsen, , Czechia
Lille, , France
Marseille, , France
Montpellier, , France
Nice, , France
Paris, , France
Paris, , France
Pessac, , France
Rennes, , France
Tours, , France
Berlin, , Germany
Berlin, , Germany
Coswig, , Germany
Donaustauf, , Germany
Essen, , Germany
Freiburg im Breisgau, , Germany
Greifswald, , Germany
Heidelberg, , Germany
Löwenstein, , Germany
München, , Germany
Dublin, , Ireland
Ashkelon, , Israel
Beersheba, , Israel
Haifa, , Israel
Haifa, , Israel
Jerusalem, , Israel
Jerusalem, , Israel
Petah Tikva, , Israel
Rehovot, , Israel
Tel Aviv, , Israel
Tel Litwinsky, , Israel
Catania, , Italy
Forlì, , Italy
Milan, , Italy
Milan, , Italy
Modena, , Italy
Napoli, , Italy
Padua, , Italy
Palermo, , Italy
Roma, , Italy
Siena, , Italy
Torino, , Italy
Guadalajara, Jalisco, Mexico
Monterrey, Nuevo León, Mexico
Huixquilucan Edo. de Mexico, , Mexico
Mexico City, DF, , Mexico
Monterrey, , Mexico
Zapopan, Jalisco, , Mexico
Almelo, , Netherlands
Callao, , Peru
Lima, , Peru
Lima, , Peru
Lima, , Peru
Lima, , Peru
Lima, , Peru
Bydgoszcz, , Poland
Lodz, , Poland
Cadiz, Andalusia, Spain
Hospital Virgen del Rocio
Seville, Andalusia, Spain
Complejo Asistencial Universitario de León
León, Castilla, Spain
Pontevedra, Galicia, Spain
Pozuelo de Alarcón, Madrid, Communidad de, Spain
Oviedo, Principality of Asturias, Spain
Badalona, , Spain
Barcelona, , Spain
Madrid, , Spain
Basel, , Switzerland
Bern, , Switzerland
Lausanne, , Switzerland
Sheffield, South Yorkshire, United Kingdom
Chertsey, Surrey, United Kingdom
Cambridge, , United Kingdom
Chelmsford, , United Kingdom
Edinburgh, , United Kingdom
Glasgow, , United Kingdom
Liverpool, , United Kingdom
London, , United Kingdom
London, , United Kingdom
Mancesheter, , United Kingdom
Countries
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References
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Raghu G, Behr J, Brown KK, Egan JJ, Kawut SM, Flaherty KR, Martinez FJ, Nathan SD, Wells AU, Collard HR, Costabel U, Richeldi L, de Andrade J, Khalil N, Morrison LD, Lederer DJ, Shao L, Li X, Pedersen PS, Montgomery AB, Chien JW, O'Riordan TG; ARTEMIS-IPF Investigators*. Treatment of idiopathic pulmonary fibrosis with ambrisentan: a parallel, randomized trial. Ann Intern Med. 2013 May 7;158(9):641-9. doi: 10.7326/0003-4819-158-9-201305070-00003.
Raghu G, Lynch D, Godwin JD, Webb R, Colby TV, Leslie KO, Behr J, Brown KK, Egan JJ, Flaherty KR, Martinez FJ, Wells AU, Shao L, Zhou H, Pedersen PS, Sood R, Montgomery AB, O'Riordan TG. Diagnosis of idiopathic pulmonary fibrosis with high-resolution CT in patients with little or no radiological evidence of honeycombing: secondary analysis of a randomised, controlled trial. Lancet Respir Med. 2014 Apr;2(4):277-84. doi: 10.1016/S2213-2600(14)70011-6. Epub 2014 Feb 18.
Chien JW, Richards TJ, Gibson KF, Zhang Y, Lindell KO, Shao L, Lyman SK, Adamkewicz JI, Smith V, Kaminski N, O'Riordan T. Serum lysyl oxidase-like 2 levels and idiopathic pulmonary fibrosis disease progression. Eur Respir J. 2014 May;43(5):1430-8. doi: 10.1183/09031936.00141013. Epub 2013 Oct 31.
Other Identifiers
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GS-US-231-0101
Identifier Type: -
Identifier Source: org_study_id
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