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Idiopathic Pulmonary FibrosisPhase 3ARTEMIS-IPFNCT00768300

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

A Phase 3 study testing Ambrisentan in people with Idiopathic Pulmonary Fibrosis, run by Gilead Sciences at 185 sites in 22 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
Ambrisentan
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
494 participants
Where
185 sitesin 22 countries
Study dates
Dec 2008to Feb 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
Show all 11Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

185 sites in 22 countries.

185 sites in 22 countries

United States57 sites

  • Pulmonary And Critical Care Services, P.C.

    Albany, New York, 12205

  • Study site

    Ann Arbor, Michigan, 48109

  • Emory University

    Atlanta, Georgia, 30322

  • Study site

    Baltimore, Maryland, 21201

  • Study site

    Baltimore, Maryland, 21205

  • University of Alabama at Birmingham Hospital

    Birmingham, Alabama, 35294

  • Study site

    Boston, Massachusetts, 02115

  • Study site

    Boston, Massachusetts, 02215

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Study site

    Charlottesville, Virginia, 22908

  • Saint Lukes Foundation

    Chesterfield, Missouri, 63017

  • University of Chicago

    Chicago, Illinois, 60637

  • Study site

    Cincinnati, Ohio, 45267

  • Bay Area Chest Physicians

    Clearwater, Florida, 33756

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44795

  • Study site

    Columbus, Ohio, 43215

  • Study site

    Council Bluffs, Iowa, 51503

  • National Jewish Medical And Research Center

    Denver, Colorado, 80206

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Study site

    Everett, Washington, 98201

  • Study site

    Falls Church, Virginia, 22042

  • Study site

    Houston, Texas, 77030

  • Dartmouth Medical School

    Lebanon, New Hampshire, 03756

  • Study site

    Lexington, South Carolina, 29072

  • David Geffen School of Medicine at UCLA(Harbor-UCLA Medical Center)

    Los Angeles, California, 90095

  • Kentuckiana Pulmonary Association

    Louisville, Kentucky, 40202

  • Study site

    Louisville, Kentucky, 40202

  • Study site

    Lynchburg, Virginia, 24501

  • Study site

    McKinney, Texas, 75069

  • University of Miami Miller School of Medicine

    Miami, Florida, 33136

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Study site

    Nashville, Tennessee, 37232

  • Study site

    New Brunswick, New Jersey, 08903

  • Study site

    New Hyde Park, New York, 11040

  • Study site

    New York, New York, 10029

  • Columbia University Medical Center

    New York, New York, 10032

  • Study site

    Newark, Delaware, 19713

  • University of Pennsylvania Health Systems

    Philadelphia, Pennsylvania, 19104

  • Study site

    Philadelphia, Pennsylvania, 19140

  • Pulmonary Associates

    Phoenix, Arizona, 85006

  • Study site

    Piscataway, New Jersey, 08854

  • Study site

    Pittsburgh, Pennsylvania, 15212

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15213

  • The Oregon Clinic, P.C.

    Portland, Oregon, 97220

  • Study site

    Provo, Utah, 84604

  • The Reading Hospital and Medical Center

    Reading, Pennsylvania, 19611

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • University of California, Davis

    Sacramento, California, 95817

  • Study site

    Salt Lake City, Utah, 84108

  • Study site

    San Diego, California, 92103-8373

  • Study site

    San Francisco, California, 94143

  • Study site

    Scottsdale, Arizona, 85258

  • Study site

    Seattle, Washington, 98195

  • Study site

    Spartanburg, South Carolina, 29303

  • Stanford University

    Stanford, California, 94305

  • Pulmonary & Allergy Associates

    Summit, New Jersey, 07091

  • Study site

    Tampa, Florida, 33606

Other trials in United States

Italy11 sites

  • Study site

    Catania, 95123

  • Study site

    Forlì, 47100

  • Study site

    Milan, 20123

  • Study site

    Milan, 20132

  • Study site

    Modena, 41100

  • Study site

    Naples, 80131

  • Study site

    Padova, 35128

  • Study site

    Palermo, 90127

  • Study site

    Roma, 00133

  • Study site

    Siena, 53100

  • Study site

    Torino, 10043

Other trials in Italy

Germany10 sites

  • Study site

    Berlin, 10117

  • Study site

    Berlin, D-13125

  • Study site

    Coswig, 01640

  • Study site

    Donaustauf, 93093

  • Study site

    Essen, D-45239

  • Study site

    Freiburg im Breisgau, 79106

  • Study site

    Greifswald, D-17475

  • Study site

    Heidelberg, 69126

  • Study site

    Löwenstein, D-74245

  • Study site

    München, 81377

Other trials in Germany

Israel10 sites

  • Study site

    Ashkelon, 78306

  • Study site

    Beersheba, 84101

  • Study site

    Haifa, 31096

  • Study site

    Haifa, 34362

  • Study site

    Jerusalem, 91031

  • Study site

    Jerusalem, 91120

  • Study site

    Petah Tikva, 49100

  • Study site

    Rehovot, 76100

  • Study site

    Tel Aviv, 64239

  • Study site

    Tel HaShomer, 52621

Other trials in Israel

United Kingdom10 sites

  • Study site

    Cambridge, CB2 2QQ

  • Study site

    Chelmsford, CM1 7ET

  • Study site

    Chertsey, Surrey, KT16 0PZ

  • Study site

    Edinburgh, EH16 4SA

  • Study site

    Glasgow, G4 0SF

  • Study site

    Liverpool, L9 7AL

  • Study site

    London, NW1 2PG

  • Study site

    London, SW3 6NP

  • Study site

    Mancesheter, M23 9LT

  • Study site

    Sheffield, South Yorkshire, S10 2JF

Other trials in United Kingdom

Brazil9 sites

  • Study site

    Belo Horizonte, 30430-1

  • Study site

    Florianópolis, 88040-970

  • Study site

    Goiânia, 74605-050

  • Study site

    Porto Alegre, 90035-074

  • Study site

    Porto Alegre, 90610-000

  • Study site

    Porto Alegre, 91350-200

  • Study site

    Rio de Janeiro, 21949-900

  • Study site

    Santo André, 09060-650

  • Study site

    São Paulo, São Paulo, 04023-062

Other trials in Brazil

France9 sites

  • Study site

    Lille, 59037

  • Study site

    Marseille, 13009

  • Study site

    Montpellier, 34295

  • Study site

    Nice, 06002

  • Study site

    Paris, 75015

  • Study site

    Paris, 75018

  • Study site

    Pessac, 33604

  • Study site

    Rennes, 35033

  • Study site

    Tours, 37044

Other trials in France

Spain9 sites

  • Study site

    Badalona, 08916

  • Study site

    Barcelona, 08036

  • Study site

    Cadiz, Andalusia, 11009

  • Complejo Asistencial Universitario de León

    León, Castilla, 24080

  • Study site

    Madrid, 28007

  • Study site

    Oviedo, Principality of Asturias, 33006

  • Study site

    Pontevedra, Galicia, 36071

  • Study site

    Pozuelo de Alarcón, Madrid, Communidad de, 28223

  • Hospital Virgen del Rocio

    Seville, Andalusia, 41011

Other trials in Spain

Australia8 sites

  • Study site

    Chermside, Queensland, 4032

  • Study site

    Concord, New South Wales, 2139

  • Study site

    Darlinghurst, New South Wales, 2010

  • Study site

    Hobart, Tasmania, 7000

  • Study site

    Parkville, Victoria, 3050

  • Study site

    Perth, Western Australia, 6000

  • Study site

    Prahran, Victoria, 3181

  • Study site

    Woodville, South Australia, 5011

Other trials in Australia

Canada8 sites

  • Study site

    Calgary, Alberta, T1Y6J4

  • Study site

    Edmondton, Alberta, T6G 2C8

  • Study site

    Montreal, Quebec, H2W1T8

  • Study site

    Sainte-Foy, Quebec, G1V 4G5

  • Study site

    St. John's, Newfoundland and Labrador, A1B 3V6

  • Study site

    Toronto, M4X1104

  • Study site

    Vancouver, British Columbia, V5Z 1M9

  • Study site

    Vancouver, British Columbia, V6Z 1YP

Other trials in Canada

Argentina6 sites

  • Study site

    Buenos Aires, C1181ACH

  • Study site

    Buenos Aires, C1280AEB

  • Study site

    Buenos Aires, C1425DES

  • Study site

    Mar del Plata, Buenos Aires, B7602DCK

  • Study site

    Mar Del Plata, Buenos Aires, B7602DCK

  • Study site

    San Miguel de Tucumán, T4000HXU

Other trials in Argentina

Czechia6 sites

  • Study site

    Brno, 625-00

  • Study site

    Hradec Králové, 500 05

  • Study site

    Jihlava, 586 33

  • Study site

    Liberec, 460 63

  • Study site

    Olomouc, 775-20

  • Study site

    Pilsen, 305 99

Other trials in Czechia

Mexico6 sites

  • Study site

    Guadalajara, Jalisco, 44670

  • Study site

    Huixquilucan Edo. de Mexico, 52763

  • Study site

    Mexico City, DF, 14080

  • Study site

    Monterrey, Nuevo León, 64718

  • Study site

    Monterrey, 64460

  • Study site

    Zapopan, Jalisco, 45200

Other trials in Mexico

Peru6 sites

  • Study site

    Callao, Callao 02

  • Study site

    Lima, L31

  • Study site

    Lima, L33

  • Study site

    Lima, Lima 01

  • Study site

    Lima, Lima 27

  • Study site

    Lima, Lima 41

Other trials in Peru

Austria4 sites

  • Study site

    Graz, 8036

  • Study site

    Innsbruck, 6020

  • Study site

    Linz, 4020

  • Study site

    Vienna, 1090

Other trials in Austria

Belgium4 sites

  • Study site

    Anderlecht, 1070

  • Study site

    Brussels, 1200

  • Study site

    Leuven, 3000

  • Study site

    Yvoir, 5530

Other trials in Belgium

Chile3 sites

  • Study site

    Santiago, 7500691

  • Study site

    Talcahuano, 4270918

  • Study site

    Valparaíso, 2352499

Other trials in Chile

Switzerland3 sites

  • Study site

    Basel, 4031

  • Study site

    Bern, 3010

  • Study site

    Lausanne, 1011

Other trials in Switzerland

Colombia2 sites

  • Study site

    Bogotá

  • Study site

    Floridablanca

Other trials in Colombia

Poland2 sites

  • Study site

    Bydgoszcz, 85-681

  • Study site

    Lodz, 90-153

Other trials in Poland

Ireland1 site

  • Study site

    Dublin, 7

Other trials in Ireland

Netherlands1 site

  • Study site

    Almelo, 7609 PP

Other trials in Netherlands

About this study

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)

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.

Being tested
Ambrisentan, Placebo
Keywords
idiopathic pulmonary fibrosis, interstitial lung disease, ambrisentan
Medical subject headings
Idiopathic Pulmonary Fibrosis, Lung Diseases, Interstitial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AmbrisentanDrug

    Also called Letairis®

    Ambrisentan (5mg or 10 mg tablet) was administered orally once daily.

  • PlaceboDrug

    Placebo to match ambrisentan was administered orally once daily.

Study groups in NCT00768300
Study groupRoleWhat they receive
AmbrisentanExperimentalNot described
Receives: Drug: Ambrisentan
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Death or Disease (IPF) Progression.

    The median time to death or disease progression was based on Kaplan-Meier (KM) estimates of pooling over strata, and was defined as the first occurrence of any of the following:

    • Either 1) a decrease of ≥ 10% in FVC (L) and a decrease of ≥ 5% in diffuse lung capacity for carbon monoxide (DLCO) (ml/min/mmHg), or 2) a decrease of ≥ 5% in FVC (L) and a decrease of ≥ 15% in DLCO (ml/min/mmHg); deterioration in FVC and DLCO must be confirmed at the subsequent visit within 28 (± 14) days
    • Respiratory hospitalization (hospitalization involving worsening of, or deterioration in respiratory symptoms, gas exchange/hypoxemia, or radiographic findings on chest x-ray or high-resolution computerised tomography (HRCT) scan
    • All-cause mortality

    Measured: Up to 48 months

Secondary outcomes (8)

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

    The proportion of participants with no disease progression or death is presented as a percentage using a Kaplan-Meier (KM) estimate of survival or not experiencing disease progression.

    Measured: Baseline and Week 48

  2. Change in FVC % Predicted at Week 48

    FVC is defined as the volume of air (liters) that can forcibly be blown out after taking a full breath. FVC % predicted is defined as FVC % of the participant divided by the average FVC % in the population for any person of similar age, sex, and body composition.

    Measured: Baseline and Week 48

  3. Change in DLCO % Predicted at Week 48

    DLCO is the extent to which oxygen passes from the air sacs of the lungs into the blood. DLCO % predicted is defined as DLCO % of the participant divided by the average DLCO % in the population for any person of similar age, sex and body composition.

    Measured: Baseline and Week 48

  4. Change in 6MWT at Week 48

    The 6MWT is a measure of exercise tolerance, and measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface.

    Measured: Baseline and Week 48

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

    The range of each health domain score is 0-100, with 0 indicating a poorer health state and 100 indicating a better health state. An increase in score indicates an improvement in health state.

    Measured: Baseline and Week 48

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

    The SGRQ is designed to measure impact on overall health, daily life, and perceived well-being in participants with obstructive airways disease. The range of each score is 0-100, with 0 indicating fewer limitations and 100 indicating more limitations; an increase in score indicates an increase in limitations.

    Measured: Baseline and Week 48

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

    The transitional focal score (-9 to 9) is the sum of relative change from baseline for the Functional Impairment, Magnitude of Task, and Magnitude of Effort scores (each -3 to 3 scale). A TDI score of -9 represents a maximum degradation of all three tests; a score of 9 represents a maximum improvement of all three tests.

    Measured: Baseline and Week 48

  8. Percentage of Participants Who Developed PH on Study

    The percentage of participants known to have developed pulmonary hypertension on study documented by right heart catheterization (RHC) was analyzed. RHC was done at baseline and 48 weeks, or at the early termination visit.

    Measured: Up to 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Oct 2008 (estimated)
  2. Study startDec 2008
  3. Primary completionFeb 2011
  4. Study completionFeb 2011

Why it stopped: Lack of efficacy

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
494 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00768300
Sponsor's protocol ID
GS-US-231-0101
Acronym
ARTEMIS-IPF
Status last verified
Feb 2014
First submitted
7 Oct 2008
Last updated
8 Apr 2014
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 23648946

  • 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.

    PubMed 24717624

  • 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.

    PubMed 24177001

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ambrisentan in people with Idiopathic Pulmonary Fibrosis, run by Gilead Sciences at 185 sites in 22 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 8 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 185 sites in United States, Italy, Germany, Israel, United Kingdom and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Apr 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Death or Disease (IPF) Progression. (time frame: Up to 48 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00768300, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2014.

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