(ARTEMIS-IPF)Randomized, Placebo-Controlled Study to Evaluate Safety and Effectiveness of Ambrisentan in IPF
This study has been terminated.
Sponsor:
Gilead Sciences
Information provided by:
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00768300
First received: October 7, 2008
Last updated: December 24, 2010
Last verified: December 2010
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Purpose
The ARTEMIS-IPF study is for people who have been diagnosed with IPF and are between 40-80 years of age. People who have been diagnosed early in the disease may be more responsive to treatment. This is a randomized study (which means the participants will be selected by chance (like flipping a coin) to receive one of two treatments (ambrisentan or placebo). This is a double-blind study which means participants and their study doctor won't know what treatment they are assigned to receive. Participants will have 2 out of 3 chances to receive ambrisentan, or 1 out of 3 chances to receive placebo (which is a tablet that looks like the active medicine but contains no active medicine)Taking part in the study could be up to 4 years depending on how long it takes to enroll and observe study events. After randomization, visits take place every 3 months. Laboratory visits occur every month.
| Condition | Intervention | Phase |
|---|---|---|
|
Idiopathic Pulmonary Fibrosis |
Drug: ambrisentan or sugar pill |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | ARTEMIS-IPF: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects With Early Idiopathic Pulmonary Fibrosis (IPF) |
Resource links provided by NLM:
Genetics Home Reference related topics:
idiopathic pulmonary fibrosis
MedlinePlus related topics:
Pulmonary Fibrosis
Drug Information available for:
Ambrisentan
U.S. FDA Resources
Further study details as provided by Gilead Sciences:
Primary Outcome Measures:
- Time to death or disease (IPF) progression. [ Time Frame: Event driven, up to 4 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportion of subjects with disease progression or death at 48 weeks [ Time Frame: 1 year from enrollment ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 660 |
| Study Start Date: | December 2008 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1 Ambrisentan
Subjects will be randomized in a 2:1 ratio to receive Ambrisentan
|
Drug: ambrisentan or sugar pill
Ambrisentan 5mg or 10 mg tablet, or sugar pill (placebo) taken once a day, by mouth for the duration of the trial.
|
|
Placebo Comparator: 2 Placebo
Subjects will be randomized in a 2:1 ratio to receive active drug versus sugar pill (placebo.
|
Drug: ambrisentan or sugar pill
Ambrisentan 5mg or 10 mg tablet, or sugar pill (placebo) taken once a day, by mouth for the duration of the trial.
|
Eligibility| Ages Eligible for Study: | 40 Years to 80 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of IPF
- Honeycombing on 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
- Able to perform the 6 minute walk test
- Must meet lung function requirements
- Normal liver function tests
Exclusion Criteria:
- No restrictive lung disease (other than IPF)
- No obstructive lung disease
- No recent or active respiratory exacerbations
- No recent hospitalization for an IPF exacerbation
- No recent history of alcohol abuse
- Not pregnant, breast-feeding and willing to follow contraceptive measures per protocol if applicable
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00768300
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Hide Study LocationsLocations
| United States, Alabama | |
| University of Alabama at Birmingham Hospital | |
| Birmingham, Alabama, United States, 35294 | |
| United States, Arizona | |
| Pulmonary Associates | |
| Phoenix, Arizona, United States, 85006 | |
| Scottsdale, Arizona, United States, 85258 | |
| United States, California | |
| David Geffen School of Medicine at UCLA(Harbor-UCLA Medical Center) | |
| Los Angeles, California, United States, 90095 | |
| University of California, Davis | |
| Sacramento, California, United States, 95817 | |
| San Diego, California, United States, 92103-8373 | |
| San Francisco, California, United States, 94143 | |
| Stanford University | |
| Stanford, California, United States, 94305 | |
| United States, Colorado | |
| National Jewish Medical And Research Center | |
| Denver, Colorado, United States, 80206 | |
| United States, Delaware | |
| Newark, Delaware, United States, 19713 | |
| United States, Florida | |
| Bay Area Chest Physicians | |
| Clearwater, Florida, United States, 33756 | |
| University of Miami Miller School of Medicine | |
| Miami, Florida, United States, 33136 | |
| Tampa, Florida, United States, 33606 | |
| United States, Georgia | |
| Emory University | |
| Atlanta, Georgia, United States, 30322 | |
| United States, Illinois | |
| University of Chicago | |
| Chicago, Illinois, United States, 60637 | |
| United States, Iowa | |
| Council Bluffs, Iowa, United States, 51503 | |
| United States, Kentucky | |
| Kentuckiana Pulmonary Association | |
| Louisville, Kentucky, United States, 40202 | |
| Louisville, Kentucky, United States, 40202 | |
| United States, Maryland | |
| Baltimore, Maryland, United States, 21205 | |
| Baltimore, Maryland, United States, 21201 | |
| United States, Massachusetts | |
| Boston, Massachusetts, United States, 02215 | |
| Boston, Massachusetts, United States, 02115 | |
| United States, Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55905 | |
| United States, Missouri | |
| Saint Lukes Foundation | |
| Chesterfield, Missouri, United States, 63017 | |
| United States, New Hampshire | |
| Dartmouth Medical School | |
| Lebanon, New Hampshire, United States, 03756 | |
| United States, New Jersey | |
| New Brunswick, New Jersey, United States, 08903 | |
| Piscataway, New Jersey, United States, 08854 | |
| Pulmonary & Allergy Associates | |
| Summit, New Jersey, United States, 07091 | |
| United States, New York | |
| Pulmonary And Critical Care Services, P.C. | |
| Albany, New York, United States, 12205 | |
| Winthrop University Hospital | |
| Mineola, New York, United States, 11501 | |
| New Hyde Park, New York, United States, 11040 | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| New York, New York, United States, 10029 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Ohio | |
| Cincinnati, Ohio, United States, 45267 | |
| The Cleveland Clinic Foundation | |
| Cleveland, Ohio, United States, 44795 | |
| Columbus, Ohio, United States, 43215 | |
| United States, Oregon | |
| The Oregon Clinic, P.C. | |
| Portland, Oregon, United States, 97220 | |
| United States, Pennsylvania | |
| University of Pennsylvania Health Systems | |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Philadelphia, Pennsylvania, United States, 19140 | |
| Pittsburgh, Pennsylvania, United States, 15212 | |
| University of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| The Reading Hospital and Medical Center | |
| Reading, Pennsylvania, United States, 19611 | |
| United States, South Carolina | |
| Medical University of South Carolina | |
| Charleston, South Carolina, United States, 29425 | |
| Lexington, South Carolina, United States, 29072 | |
| Spartanburg, South Carolina, United States, 29303 | |
| United States, Tennessee | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| Houston, Texas, United States, 77030 | |
| McKinney, Texas, United States, 75069 | |
| United States, Utah | |
| Provo, Utah, United States, 84604 | |
| Salt Lake City, Utah, United States, 84108 | |
| United States, Virginia | |
| Charlottesville, Virginia, United States, 22908 | |
| Falls Church, Virginia, United States, 22042 | |
| Lynchburg, Virginia, United States, 24501 | |
| United States, Washington | |
| Everett, Washington, United States, 98201 | |
| Seattle, Washington, United States, 98195 | |
| Argentina | |
| Mar del Plata, Provincia de Buenos Aires, Argentina, B7602DCK | |
| Buenos Aires, Argentina, C1425DES | |
| Ciudad Autonoma de Buenos Aires, Argentina, C1181ACH | |
| Ciudad Autonoma de Buenos Aires, Argentina, C1280AEB | |
| Mar del Plata, Buenos Aires, Argentina, B7602DCK | |
| San Miguel de Tucuman, Argentina, T4000HXU | |
| Australia, New South Wales | |
| Concord, New South Wales, Australia, 2139 | |
| Darlinghurst, New South Wales, Australia, 2010 | |
| Australia, Queensland | |
| Chermside, Queensland, Australia, 4032 | |
| Australia, South Australia | |
| Woodville, South Australia, Australia, 5011 | |
| Australia, Tasmania | |
| Hobart, Tasmania, Australia, 7000 | |
| Australia, Victoria | |
| Parkville, Victoria, Australia, 3050 | |
| Prahran, Victoria, Australia, 3181 | |
| Australia, Western Australia | |
| Perth, Western Australia, Australia, 6000 | |
| Austria | |
| Graz, Austria, 8036 | |
| Innsbruck, Austria, 6020 | |
| Linz, Austria, 4020 | |
| Wien, Austria, 1090 | |
| Belgium | |
| Anderlecht, Belgium, 1070 | |
| Bruxelles, Belgium, 1200 | |
| Leuven, Belgium, 3000 | |
| Yvoir, Belgium, 5530 | |
| Brazil | |
| Belo Horizonte, Brazil, 30430-1 | |
| Florianopolis, Brazil, 88040-970 | |
| Goiania, Brazil, 74605-050 | |
| Porto Alegre, Brazil, 90035-074 | |
| Porto Alegre, Brazil, 90610-000 | |
| Porto Alegre, Brazil, 91350-200 | |
| Rio de Janeiro, Brazil, 21949-900 | |
| Santo Andre, Brazil, 09060-650 | |
| Sao Paolo, Brazil, 04023-062 | |
| Canada, Alberta | |
| Calgary, Alberta, Canada, T1Y6J4 | |
| Edmondton, Alberta, Canada, T6G 2C8 | |
| Canada, British Columbia | |
| Vancouver, British Columbia, Canada, V5Z 1M9 | |
| Vancouver, British Columbia, Canada, V6Z 1YP | |
| Canada, Newfoundland and Labrador | |
| St. Johns, Newfoundland and Labrador, Canada, A1B 3V6 | |
| Canada, Quebec | |
| Montreal, Quebec, Canada, H2W1T8 | |
| Sainte Foy, Quebec, Canada, G1V 4G5 | |
| Canada | |
| Toronto, Canada, M4X1104 | |
| Chile | |
| Santiago, Chile, 7500691 | |
| Talcahuano, Chile, 4270918 | |
| Valparaiso, Chile, 2352499 | |
| Colombia | |
| Bogota, Colombia | |
| Floridablanca, Colombia | |
| Czech Republic | |
| Brno, Czech Republic, 625-00 | |
| Hradec Kralove, Czech Republic, 500 05 | |
| Jihlava, Czech Republic, 586 33 | |
| Liberec, Czech Republic, 460 63 | |
| Olomouc, Czech Republic, 775-20 | |
| Plzen, Czech Republic, 305 99 | |
| France | |
| Lille, France, 59037 | |
| Marseille, France, 13009 | |
| Montpellier, France, 34295 | |
| Nice, France, 06002 | |
| Paris, France, 75015 | |
| Paris, France, 75018 | |
| Pessac, France, 33604 | |
| Rennes, France, 35033 | |
| Tours, France, 37044 | |
| Germany | |
| Berlin, Germany, 10117 | |
| Berlin, Germany, D-13125 | |
| Coswig, Germany, 01640 | |
| Donaustauf, Germany, 93093 | |
| Essen, Germany, D-45239 | |
| Freiburg, Germany, 79106 | |
| Greifswald, Germany, D-17475 | |
| Heidelberg, Germany, 69126 | |
| Lowenstein, Germany, D-74245 | |
| Munchen, Germany, 81377 | |
| Ireland | |
| Dublin, Ireland, 7 | |
| Israel | |
| Ashkelon, Israel, 78306 | |
| Beer-Sheva, Israel, 84101 | |
| Haifa, Israel, 34362 | |
| Haifa, Israel, 31096 | |
| Jerusalem, Israel, 91031 | |
| Jerusalem, Israel, 91120 | |
| Petach Tikva, Israel, 49100 | |
| Rehovot, Israel, 76100 | |
| Tel Aviv, Israel, 64239 | |
| Tel-Hashomer, Israel, 52621 | |
| Italy | |
| Catania, Italy, 95123 | |
| Forlì, Italy, 47100 | |
| Milano, Italy, 20123 | |
| Milano, Italy, 20132 | |
| Modena, Italy, 41100 | |
| Napoli, Italy, 80131 | |
| Padova, Italy, 35128 | |
| Palermo, Italy, 90127 | |
| Roma, Italy, 00133 | |
| Siena, Italy, 53100 | |
| Torino, Italy, 10043 | |
| Mexico | |
| Guadalajara, Jalisco, Mexico, 44670 | |
| Monterrey, Nuevo Leon, Mexico, 64718 | |
| Huixquilucan Edo. de Mexico, Mexico, 52763 | |
| Mexico City, DF, Mexico, 14080 | |
| Monterrey, Mexico, 64460 | |
| Zapopan, Jalisco, Mexico, 45200 | |
| Netherlands | |
| Almelo, Netherlands, 7609 PP | |
| Peru | |
| Callao, Peru, Callao 02 | |
| Lima, Peru, L31 | |
| Lima, Peru, Lima 27 | |
| Lima, Peru, L33 | |
| Lima, Peru, Lima 41 | |
| Lima, Peru, Lima 01 | |
| Poland | |
| Bydgoszcz, Poland, 85-681 | |
| Lodz, Poland, 90-153 | |
| Spain | |
| Cadiz, Andalucia, Spain, 11009 | |
| Hospital Virgen del Rocio | |
| Sevilla, Andalucia, Spain, 41011 | |
| Oviedo, Asturias, Spain, 33006 | |
| Complejo Asistencial Universitario de León | |
| Leon, Castilla, Spain, 24080 | |
| Pontevedra, Galicia, Spain, 36071 | |
| Pozuelo de Alarcon, Madrid, Communidad de, Spain, 28223 | |
| Badalona, Spain, 08916 | |
| Barcelona, Spain, 08036 | |
| Madrid, Spain, 28007 | |
| Switzerland | |
| Basel, Switzerland, 4031 | |
| Bern, Switzerland, 3010 | |
| Lausanne, Switzerland, 1011 | |
| United Kingdom | |
| Sheffield, South Yorkshire, United Kingdom, S10 2JF | |
| Chertsey, Surrey, United Kingdom, KT16 0PZ | |
| Cambridge, United Kingdom, CB2 2QQ | |
| Chelmsford, United Kingdom, CM1 7ET | |
| Edinburgh, United Kingdom, EH16 4SA | |
| Glasgow, United Kingdom, G4 0SF | |
| Liverpool, United Kingdom, L9 7AL | |
| London, United Kingdom, SW3 6NP | |
| London, United Kingdom, NW1 2PG | |
| Mancesheter, United Kingdom, M23 9LT | |
Sponsors and Collaborators
Gilead Sciences
Investigators
| Study Chair: | Ganesh Raghu, MD | University of Washington, Div. of Pulmonary and Critical Care Medicine Chair |
More Information
No publications provided
| Responsible Party: | Thomas O'Riordan, MD, GSI |
| ClinicalTrials.gov Identifier: | NCT00768300 History of Changes |
| Other Study ID Numbers: | GS-US-231-0101 |
| Study First Received: | October 7, 2008 |
| Last Updated: | December 24, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Gilead Sciences:
|
idiopathic pulmonary fibrosis interstitial lung disease ambrisentan |
Additional relevant MeSH terms:
|
Fibrosis Pulmonary Fibrosis Idiopathic Pulmonary Fibrosis Pathologic Processes |
Lung Diseases Respiratory Tract Diseases Idiopathic Interstitial Pneumonias Lung Diseases, Interstitial |
ClinicalTrials.gov processed this record on June 18, 2013