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(ARTEMIS-IPF) Randomized, Placebo-Controlled Study to Evaluate Safety and Effectiveness of Ambrisentan in IPF

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

Intervention: Ambrisentan (Drug); Placebo (Drug)

Phase: Phase 3

Status: Terminated

Sponsored by: Gilead Sciences

Official(s) and/or principal investigator(s):
Ganesh Raghu, MD, Study Chair, Affiliation: University of Washington, Div. of Pulmonary and Critical Care Medicine Chair

Summary

The ARTEMIS-IPF study was conducted to determine if ambrisentan was effective in delaying disease progression and death in participants with idiopathic pulmonary fibrosis (IPF), to evaluate its safety, and to evaluate its effect on development of pulmonary hypertension, quality of life, and dyspnea (shortness of breath) symptoms in this participant population. Participants were randomized in a 2: 1 ratio to receive ambrisentan or placebo, respectively. Participation in the study was to be up to 4 years, depending on how long it would take to enroll participants and observe study events. After randomization, visits to the clinic took place every 3 months, and laboratory procedures were performed every month.

Clinical Details

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)

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

Primary outcome: Time to Death or Disease (IPF) Progression.

Secondary outcome:

Proportion of Participants With No Disease Progression or Death at 48 Weeks

Change in FVC % Predicted at Week 48

Change in DLCO % Predicted at Week 48

Change in 6MWT at Week 48

Change in Quality of Life (QOL) Score at Week 48 as Assessed by the Short-Form 36® (SF-36)

Change in Quality of Life (QOL) Score at Week 48 as Assessed by the St. George's Respiratory Questionnaire (SGRQ)

Change in Dyspnea Score at Week 48 as Assessed by the Transitional Dyspnea Index (TDI)

Percentage of Participants Who Developed PH on Study

Eligibility

Minimum age: 40 Years. Maximum age: 80 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Male or females from 40 to 80 years of age

- 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 restrictive lung disease (other than usual interstitial pneumonia or IPF)

- 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

Locations and Contacts

Buenos Aires C1425DES, Argentina

Ciudad Autonoma de Buenos Aires C1181ACH, Argentina

Ciudad Autonoma de Buenos Aires C1280AEB, Argentina

Mar del Plata, Buenos Aires B7602DCK, Argentina

San Miguel de Tucuman T4000HXU, Argentina

Graz 8036, Austria

Innsbruck 6020, Austria

Linz 4020, Austria

Wien 1090, Austria

Anderlecht 1070, Belgium

Bruxelles 1200, Belgium

Leuven 3000, Belgium

Yvoir 5530, Belgium

Belo Horizonte 30430-1, Brazil

Florianopolis 88040-970, Brazil

Goiania 74605-050, Brazil

Porto Alegre 90035-074, Brazil

Porto Alegre 90610-000, Brazil

Porto Alegre 91350-200, Brazil

Rio de Janeiro 21949-900, Brazil

Santo Andre 09060-650, Brazil

Sao Paolo 04023-062, Brazil

Toronto M4X1104, Canada

Santiago 7500691, Chile

Talcahuano 4270918, Chile

Valparaiso 2352499, Chile

Bogota, Colombia

Floridablanca, Colombia

Brno 625-00, Czech Republic

Hradec Kralove 500 05, Czech Republic

Jihlava 586 33, Czech Republic

Liberec 460 63, Czech Republic

Olomouc 775-20, Czech Republic

Plzen 305 99, Czech Republic

Lille 59037, France

Marseille 13009, France

Montpellier 34295, France

Nice 06002, France

Paris 75015, France

Paris 75018, France

Pessac 33604, France

Rennes 35033, France

Tours 37044, France

Berlin 10117, Germany

Berlin D-13125, Germany

Coswig 01640, Germany

Donaustauf 93093, Germany

Essen D-45239, Germany

Freiburg 79106, Germany

Greifswald D-17475, Germany

Heidelberg 69126, Germany

Lowenstein D-74245, Germany

Munchen 81377, Germany

Dublin 7, Ireland

Ashkelon 78306, Israel

Beer-Sheva 84101, Israel

Haifa 34362, Israel

Haifa 31096, Israel

Jerusalem 91031, Israel

Jerusalem 91120, Israel

Petach Tikva 49100, Israel

Rehovot 76100, Israel

Tel Aviv 64239, Israel

Tel-Hashomer 52621, Israel

Catania 95123, Italy

Forlì 47100, Italy

Milano 20123, Italy

Milano 20132, Italy

Modena 41100, Italy

Napoli 80131, Italy

Padova 35128, Italy

Palermo 90127, Italy

Roma 00133, Italy

Siena 53100, Italy

Torino 10043, Italy

Huixquilucan Edo. de Mexico 52763, Mexico

Mexico City, DF 14080, Mexico

Monterrey 64460, Mexico

Zapopan, Jalisco 45200, Mexico

Almelo 7609 PP, Netherlands

Callao Callao 02, Peru

Lima Lima 41, Peru

Lima L33, Peru

Lima Lima 01, Peru

Lima Lima 27, Peru

Lima L31, Peru

Bydgoszcz 85-681, Poland

Lodz 90-153, Poland

Badalona 08916, Spain

Barcelona 08036, Spain

Madrid 28007, Spain

Basel 4031, Switzerland

Bern 3010, Switzerland

Lausanne 1011, Switzerland

Cambridge CB2 2QQ, United Kingdom

Chelmsford CM1 7ET, United Kingdom

Edinburgh EH16 4SA, United Kingdom

Glasgow G4 0SF, United Kingdom

Liverpool L9 7AL, United Kingdom

London NW1 2PG, United Kingdom

London SW3 6NP, United Kingdom

Mancesheter M23 9LT, United Kingdom

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

Calgary, Alberta T1Y6J4, Canada

Edmondton, Alberta T6G 2C8, Canada

Cadiz, Andalucia 11009, Spain

Hospital Virgen del Rocio, Sevilla, Andalucia 41011, Spain

Pulmonary Associates, Phoenix, Arizona 85006, United States

Scottsdale, Arizona 85258, United States

Oviedo, Asturias 33006, Spain

Vancouver, British Columbia V5Z 1M9, Canada

Vancouver, British Columbia V6Z 1YP, Canada

David Geffen School of Medicine at UCLA(Harbor-UCLA Medical Center), Los Angeles, California 90095, United States

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

San Diego, California 92103-8373, United States

San Francisco, California 94143, United States

Stanford University, Stanford, California 94305, United States

Complejo Asistencial Universitario de León, Leon, Castilla 24080, Spain

National Jewish Medical And Research Center, Denver, Colorado 80206, United States

Newark, Delaware 19713, United States

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

University of Miami Miller School of Medicine, Miami, Florida 33136, United States

Tampa, Florida 33606, United States

Pontevedra, Galicia 36071, Spain

Emory University, Atlanta, Georgia 30322, United States

University of Chicago, Chicago, Illinois 60637, United States

Council Bluffs, Iowa 51503, United States

Guadalajara, Jalisco 44670, Mexico

Louisville, Kentucky 40202, United States

Kentuckiana Pulmonary Association, Louisville, Kentucky 40202, United States

Pozuelo de Alarcon, Madrid, Communidad de 28223, Spain

Baltimore, Maryland 21201, United States

Baltimore, Maryland 21205, United States

Boston, Massachusetts 02115, United States

Boston, Massachusetts 02215, United States

Ann Arbor, Michigan 48109, United States

Mayo Clinic, Rochester, Minnesota 55905, United States

Saint Lukes Foundation, Chesterfield, Missouri 63017, United States

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

New Brunswick, New Jersey 08903, United States

Piscataway, New Jersey 08854, United States

Pulmonary & Allergy Associates, Summit, New Jersey 07091, United States

Concord, New South Wales 2139, Australia

Darlinghurst, New South Wales 2010, Australia

Pulmonary And Critical Care Services, P.C., Albany, New York 12205, United States

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

New Hyde Park, New York 11040, United States

New York, New York 10029, United States

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

St. Johns, Newfoundland and Labrador A1B 3V6, Canada

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

Monterrey, Nuevo Leon 64718, Mexico

Cincinnati, Ohio 45267, United States

The Cleveland Clinic Foundation, Cleveland, Ohio 44795, United States

Columbus, Ohio 43215, United States

The Oregon Clinic, P.C., Portland, Oregon 97220, United States

Philadelphia, Pennsylvania 19140, United States

University of Pennsylvania Health Systems, Philadelphia, Pennsylvania 19104, United States

Pittsburgh, Pennsylvania 15212, United States

University of Pittsburgh, Pittsburgh, Pennsylvania 15213, United States

The Reading Hospital and Medical Center, Reading, Pennsylvania 19611, United States

Mar del Plata, Provincia de Buenos Aires B7602DCK, Argentina

Montreal, Quebec H2W1T8, Canada

Sainte Foy, Quebec G1V 4G5, Canada

Chermside, Queensland 4032, Australia

Woodville, South Australia 5011, Australia

Medical University of South Carolina, Charleston, South Carolina 29425, United States

Lexington, South Carolina 29072, United States

Spartanburg, South Carolina 29303, United States

Sheffield, South Yorkshire S10 2JF, United Kingdom

Chertsey, Surrey KT16 0PZ, United Kingdom

Hobart, Tasmania 7000, Australia

Nashville, Tennessee 37232, United States

Houston, Texas 77030, United States

McKinney, Texas 75069, United States

Provo, Utah 84604, United States

Salt Lake City, Utah 84108, United States

Parkville, Victoria 3050, Australia

Prahran, Victoria 3181, Australia

Charlottesville, Virginia 22908, United States

Falls Church, Virginia 22042, United States

Lynchburg, Virginia 24501, United States

Everett, Washington 98201, United States

Seattle, Washington 98195, United States

Perth, Western Australia 6000, Australia

Additional Information

Starting date: December 2008
Last updated: February 27, 2014

Page last updated: August 23, 2015

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