ARTEMIS-PH - Study of Ambrisentan in Subjects With Pulmonary Hypertension Associated With Idiopathic Pulmonary Fibrosis
ARTEMIS-PH
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
1 other identifier
interventional
40
6 countries
82
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started Jul 2009
82 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 8, 2009
CompletedFirst Posted
Study publicly available on registry
April 9, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2011
CompletedResults Posted
Study results publicly available
April 22, 2014
CompletedMay 15, 2014
May 1, 2014
1.6 years
April 8, 2009
August 9, 2013
May 5, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline in Six-minute Walk Distance (6MWD).
The change from baseline in 6MWD at Week 16 (end of blinded treatment) was evaluated.
Baseline to Week 16
Secondary Outcomes (9)
Long-term Survival
Week 48
Transition Dyspnea Index (TDI)
Baseline to Week 16
Change From Baseline in WHO Functional Class
Baseline to Week 16
Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted
Baseline to Week 16
Change From Baseline in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP)
Baseline to Week 16
- +4 more secondary outcomes
Study Arms (2)
Ambrisentan
EXPERIMENTALParticipants 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
Placebo
PLACEBO COMPARATORParticipants 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.
Interventions
Ambrisentan (5 mg or 10 mg tablet) administered orally once daily.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
Study Sites (85)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Mayo Clinic Arizona
Scottsdale, Arizona, 85259, United States
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
Suncoast Lung Center
Sarasota, Florida, 34233, United States
Sarasota Memorial Hospital
Sarasota, Florida, 34239, 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
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Boston University Medical Center
Boston, Massachusetts, 02118, United States
Beth Israel Deacones Medical Center
Boston, Massachusetts, 02215, 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
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
Mount Sinai School of Medicine
New York, New York, 10029, United States
Columbia University
New York, New York, 10032, 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
University Hospitals of Cleveland Case Western
Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation
Cleveland, Ohio, 44195, United States
Ohio State University
Columbus, Ohio, 43210, United States
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
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
St. Vincents Hospital
Sydney, New South Wales, 2010, Australia
The Prince Charles Hospital
Chermside, Queensland, 4032, Australia
Royal Perth Hospital
Perth, Western Australia, 6000, Australia
Medizinische Universität Graz
Graz, 8036, Austria
Universitatsklinikum Innsbruck
Innsbruck, Austria
Medizinische Universität Wien
Vienna, 1090, Austria
Peter Loughheed Center- Calgary General Hospital
Calgary, Alberta, T1Y 6J4, Canada
University of British Columbia
Vancouver, British Columbia, V5Z 1M9, Canada
London Health Sciences Centre
London, Ontario, N6A 5W9, Canada
Toronto General Hospital
Toronto, Ontario, Canada
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
Evangelische Lungenklinik Berlin
Berlin, 13125, Germany
Charite-Universitatsmedizin Berlin
Berlin, Germany
Krankenhaus Donaustauf der LVA
Donaustauf, 93093, Germany
Universitatsklinikum Freiburg
Freiburg im Breisgau, 79095, Germany
Universitat Greifswald
Greifswald, 17475, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Thorax Klinik
Heidelberg, 66126, 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, 20132, 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, 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
Related Publications (1)
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.
PMID: 25613108DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
Study GS-US-300-0128 was terminated early with enrollment of 40 of 225 planned subjects.
Results Point of Contact
- Title
- Clinical Trial Disclosures
- Organization
- Gilead Sciences, Inc.
Study Officials
- STUDY DIRECTOR
Hunter Gillies, M.D.
Gilead Sciences
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 8, 2009
First Posted
April 9, 2009
Study Start
July 1, 2009
Primary Completion
February 1, 2011
Study Completion
February 1, 2011
Last Updated
May 15, 2014
Results First Posted
April 22, 2014
Record last verified: 2014-05