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ARTEMIS-PH - Study of Ambrisentan in Subjects With Pulmonary Hypertension Associated With Idiopathic Pulmonary Fibrosis

Information source: Gilead Sciences
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Idiopathic Pulmonary Fibrosis; Pulmonary Hypertension

Intervention: Ambrisentan (Drug); Placebo (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Gilead Sciences

Official(s) and/or principal investigator(s):
Hunter Gillies, M.D., Study Director, Affiliation: Gilead Sciences


Ambrisentan is an endothelin receptor antagonist used for the treatment of pulmonary hypertension (PH). Based on research suggesting a role for endothelin-1 in the pathogenesis of idiopathic pulmonary fibrosis (IPF) and the poor prognosis for patients with IPF who are also diagnosed with PH, this study was designed to evaluate the effectiveness and safety of ambrisentan in that patient population.

Clinical Details

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects With Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Change From Baseline in Six-minute Walk Distance (6MWD).

Secondary outcome:

Long-term Survival

Transition Dyspnea Index (TDI)

Change From Baseline in WHO Functional Class

Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted

Change From Baseline in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP)

Change From Baseline in the Borg Dyspnea Index (BORG) Immediately Following Exercise

Hemoglobin-corrected Diffusing Capacity for Carbon Monoxide (DLCO) Percent Predicted

Change in Quality of Life (QOL) Score as Assessed by the Short-Form 36® (SF-36)

Change in QOL Score as Assessed by the St. George's Respiratory Questionnaire (SRGQ)


Minimum age: 35 Years. Maximum age: 80 Years. Gender(s): Both.


Selected Inclusion Criteria:

- Weight ≥ 40 kg at screening

- 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. Selected Exclusion Criteria:

- Diagnosis of PH primarily due to an etiology other than IPF

- 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

Locations and Contacts

Medizinische Universität Graz, Graz 8036, Austria

Universitatsklinikum Innsbruck, Innsbruck, Austria

Medizinische Universität Wien, Vienna 1090, Austria

Charite-Universitatsmedizin Berlin, Berlin, Germany

Evangelische Lungenklinik Berlin, Berlin 13125, Germany

Krankenhaus Donaustauf der LVA, Donaustauf 93093, Germany

Universitatsklinikum Freiburg, Freiburg 79095, Germany

Universitat Greifswald, Greifswald 17475, Germany

Medizinische Hochschule Hannover, Hannover 30625, Germany

Thorax Klinik, Heidelberg 66126, Germany

LMU Klinikum der Universitat, Munchen, Germany

Azienda Ospedaliero Universitaria, Catania, Italy

Presidio Ospedaliero G.B. Morgagni, Forli, Italy

Unita Funzionale di Pneumologia e Fisiopatologia Respiratoria, Milano 20132, Italy

Ospedale S.Giuseppe Fatebenefratelli, Milan, Italy

Azienda Ospedaliera di Padova, Padova, Italy

Instituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione, Palermo, Italy

Policlinico Universitario Tor Vergata, Rome, Italy

Azienda Ospedaliera Universitaria Senese, Siena 53100, Italy

Centro delle Interstiziopatie Polmonari e Malattie Rare del Polmone, Torino 10043, Italy

Papworth Hospital NHS Foundation Trust, Cambridge CB23 3RE, United Kingdom

University Hospital Aintree, Liverpool, United Kingdom

University College Hosptial, London, United Kingdom

Royal Hallamshire Hospital, Sheffield, United Kingdom

University of Alabama at Birmingham, Birmingham, Alabama 35294, United States

Peter Loughheed Center- Calgary General Hospital, Calgary, Alberta T1Y 6J4, Canada

Mayo Clinic Arizona, Scottsdale, Arizona 85259, United States

University of British Columbia, Vancouver, British Columbia V5Z 1M9, Canada

University of California Davis, Davis, California 95817, United States

David Geffen School of Medicine UCLA, Los Angeles, California 90095, United States

University of California San Diego Medical Center, San Diego, California 92103, United States

University of California at San Francisco, San Francisco, California 94143, United States

Stanford University, Stanford, California 94305, United States

University of Colorado Heatlh Sciences Center, Aurora, Colorado 80045, United States

Bay Area Chest Physicians, Clearwater, Florida 33756, United States

University of Florida, Gainesville, Florida 32610, United States

University of Miami Medical Center, Miami, Florida 33136, United States

Sarasota Memorial Hospital, Sarasota, Florida 34239, United States

Suncoast Lung Center, Sarasota, Florida 34233, United States

Cleveland Clinic Florida, Weston, Florida 33331, United States

Atlanta Institute for Medical Research, Decatur, Georgia 30030, United States

University of Chicago, Chicago, Illinois 60637, United States

Kentuckiana Pulmonary Association, Louisville, Kentucky, United States

Maine Medical Center, Portland, Maine, United States

Johns Hopkins University School of Medicine, Baltimore, Maryland 21205, United States

Beth Israel Deacones Medical Center, Boston, Massachusetts 02215, United States

Boston University Medical Center, Boston, Massachusetts 02118, United States

Brigham and Women's Hospital, Boston, Massachusetts 02115, United States

Tufts Medical Center, Boston, Massachusetts 02111, United States

University of Michigan Health Systems, Ann Arbor, Michigan 48109, United States

Mayo Clinic Rochester, Rochester, Minnesota 55905, United States

Washington University, St Louis, Missouri 63110, United States

Creighton University Center for Allergy & Asthma, Omaha, Nebraska 68131, United States

Dartmouth Medical School, Lebanon, New Hampshire 03756, United States

St. Vincents Hospital, Sydney, New South Wales 2010, Australia

Albany Medical Center, Albany, New York 12208, United States

Winthrop University Hospital, Mineola, New York 11501, United States

North Shore Health System, New Hyde Park, New York 11040, United States

Columbia University, New York, New York 10032, United States

Mount Sinai School of Medicine, New York, New York 10029, United States

University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599, United States

Duke University Medical Center, Durham, North Carolina 27710, United States

The Lindner Center for Research & Education at The Christ Hospital, Cincinnati, Ohio 45219, United States

Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States

University Hospitals of Cleveland Case Western, Cleveland, Ohio 44106, United States

Ohio State University, Columbus, Ohio 43210, United States

London Health Sciences Centre, London, Ontario N6A 5W9, Canada

Toronto General Hospital, Toronto, Ontario, Canada

Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania 19104, United States

Temple University School of Medicine, Philadelphia, Pennsylvania 19140, United States

Alleghany General Hospital, Pittsburgh, Pennsylvania 12512, United States

University of Pittsburgh Cancer Institute, Pittsburgh, Pennsylvania 15213, United States

Centre Hospitalier De L'Universite de Montreal, Montreal, Quebec H2W 1T8, Canada

Sir Mortimer B. Davis Jewish General Center, Montreal, Quebec, Canada

Centre de Pneumologie de L'Hospital Laval, Sainte foy, Quebec G1V 4G5, Canada

The Prince Charles Hospital, Chermside, Queensland 4032, Australia

Medical University of South Carolina, Charleston, South Carolina, United States

Vanderbilt University Medical Center, Nashville, Tennessee 37232, United States

University of Texas Southwestern, Dallas, Texas 75390, United States

Baylor College of Medicine, Houston, Texas 77030, United States

University of Utah, Salt Lake City, Utah 84108, United States

Inova Heart Institiute and Vascular Institute, Falls Church, Virginia 22042, United States

Virginia Commonwealth University Health System, Richmond, Virginia 23298, United States

Providence Everett Medical Center, Everett, Washington 98201, United States

Royal Perth Hospital, Perth, Western Australia 6000, Australia

Additional Information

Starting date: July 2009
Last updated: May 5, 2014

Page last updated: August 23, 2015

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