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TerminatedNCT00768300ARTEMIS-IPFUpdated Apr 8, 2014Results posted

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

A Phase 3 interventional study of Ambrisentan and Placebo in Idiopathic Pulmonary Fibrosis, sponsored by Gilead Sciences. Terminated at 185 sites in 22 countries. Open to participants aged 40 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-04-08.

Sponsored by Gilead Sciences · Phase 3, Interventional, and Treatment

Why this study was terminated
Lack of efficacy
Phase
Phase 3
Study type
Interventional
Enrollment
494
Allocation
Randomized
Ages
40 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Idiopathic Pulmonary Fibrosis

Keywords

  • idiopathic pulmonary fibrosis
  • interstitial lung disease
  • ambrisentan
03

In context

Pulmonary Fibrosis

680 studies on the registry are indexed under Pulmonary Fibrosis; 119 are open to participants now.

This study's enrollment of 494 is above the median of 50 across 419 interventional studies indexed under Pulmonary Fibrosis.

Browse Pulmonary Fibrosis studies →

Lead sponsor

Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
494 participants (actual)

Study arms

  • Experimental
    Ambrisentan

    Drug: Ambrisentan

  • Placebo comparator
    Placebo

    Drug: Placebo

Interventions

  • DrugAmbrisentan

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

    Also known as: Letairis®

  • DrugPlacebo

    Placebo to match ambrisentan was administered orally once daily.

06

What researchers measure

Primary outcomes

  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

    Time frame: Up to 48 months

Secondary outcomes

  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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: 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.

    Time frame: Up to 48 weeks

07

Results

Posted Apr 8, 2014

Participant flow

Participants were enrolled in a total of 136 study sites in North and South America, Europe, and Australia. The first participant was screened on 10 December 2008. The last participant observation was on 28 February 2011.

Participant flow — Overall Study
MilestoneAmbrisentanPlacebo
Started330164
Randomized and treated329163
Completed11
Not completed329163
Withdrew: Randomized but not treated11
Withdrew: Adverse event102
Withdrew: Protocol violation61
Withdrew: Withdrawal by subject137
Withdrew: Physician decision23
Withdrew: Study discontinued by sponsor271140
Withdrew: Death215
Withdrew: Subject moved to pursue lung transplant11
Withdrew: Screen failure following randomization10
Withdrew: Received lung transplant11
Withdrew: Lost to follow-up01
Withdrew: Began prohibited concomitant medication01
Withdrew: Treated but never dosed with study drug10
Withdrew: Missing data10

Outcome measures

PrimaryTime 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

Time frame:
Up to 48 months
Reported as:
Median · weeks
Time to Death or Disease (IPF) Progression.
weeksAmbrisentanPlacebo
Time to Death or Disease (IPF) Progression.84.14 (36.00 to NA)NA (60.00 to NA)
Statistical analysis
  • Ambrisentan vs Placebo · Log Rank · p = 0.010 (P-value was based on a stratified log-rank test with strata of baseline presence of pulmonary hypertension and whether a surgical lung biopsy was performed with definite or probable usual interstitial pneumonia (UIP) based on core pathology review.) · Hazard ratio (hr): 1.74 · 95% CI 1.14 to 2.66The hazard ratio was based on a stratified Cox proportional hazards model with strata of baseline presence of pulmonary hypertension and whether a surgical lung biopsy was performed with definite or probable UIP based on core pathology review.
SecondaryProportion 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.

Time frame:
Baseline and Week 48
Reported as:
Number · percentage of participants
Proportion of Participants With No Disease Progression or Death at 48 Weeks
percentage of participantsAmbrisentanPlacebo
Proportion of Participants With No Disease Progression or Death at 48 Weeks6580
SecondaryChange 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.

Time frame:
Baseline and Week 48
Reported as:
Mean · percent change in FVC % predicted
Change in FVC % Predicted at Week 48
percent change in FVC % predictedAmbrisentanPlacebo
Change in FVC % Predicted at Week 48-10.24 ± 25.95-5.28 ± 15.68
Statistical analysis
  • Ambrisentan vs Placebo · Van Elteren test · p = 0.086 (P-value was calculated using the Van Elteren test with strata of baseline presence of PH and whether a SLB was performed with definite or probable UIP based on core pathology review.) · Point estimate: 4.29 · 95% CI -0.805 to 9.376The point estimate and 95% confidence interval (CI) were based on the Hodges-Lehmann Estimate of treatment effect for percent change from baseline.
SecondaryChange 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.

Time frame:
Baseline and Week 48
Reported as:
Mean · percent change in DLCO % predicted
Change in DLCO % Predicted at Week 48
percent change in DLCO % predictedAmbrisentanPlacebo
Change in DLCO % Predicted at Week 48-2.68 ± 27.60-11.28 ± 32.06
Statistical analysis
  • Ambrisentan vs Placebo · Van Elteren test · p = 0.250 (P-value was calculated using the Van Elteren test with strata of baseline presence of PH and whether a SLB was performed with definite or probable UIP based on core pathology review.) · Point estimate: 2.85 · 95% CI -2.20 to 7.90The point estimate and its 95% CI were based on the Hodges-Lehmann Estimate of treatment effect for percent change from baseline.
SecondaryChange 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.

Time frame:
Baseline and Week 48
Reported as:
Mean · meters
Change in 6MWT at Week 48
metersAmbrisentanPlacebo
Change in 6MWT at Week 48-52.5 ± 148.7-10.6 ± 89.8
Statistical analysis
  • Ambrisentan vs Placebo · Van Elteren test · p = 0.150 (P-value was calculated using the Van Elteren test with strata of baseline presence of PH and whether a SLB was performed with definite or probable UIP based on core pathology review.) · Point estimate: 16.00 · 95% CI -5.00 to 37.00The point estimate and 95% CI were based on the Hodges-Lehmann Estimate of treatment effect for percent change from baseline.
SecondaryChange 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.

Time frame:
Baseline and Week 48
Reported as:
Mean · units on a scale
Change in Quality of Life (QOL) Score at Week 48 as Assessed by the Short-Form 36® (SF-36)
units on a scaleAmbrisentanPlacebo
Physical function-1.65 ± 10.86-2.60 ± 7.25
General Health-2.81 ± 9.77-1.95 ± 8.63
Vitality-1.67 ± 12.67-0.12 ± 7.69
SecondaryChange 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.

Time frame:
Baseline and Week 48
Reported as:
Mean · units on a scale
Change in Quality of Life (QOL) Score at Week 48 as Assessed by the St. George's Respiratory Questionnaire (SGRQ)
units on a scaleAmbrisentanPlacebo
Symptoms Score3.30 ± 22.112.84 ± 20.43
Activity Score5.54 ± 19.382.05 ± 16.47
Impacts Score4.68 ± 24.073.09 ± 15.80
Total Score4.70 ± 19.923.04 ± 13.80
SecondaryChange 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.

Time frame:
Baseline and Week 48
Reported as:
Mean · units on a scale
Change in Dyspnea Score at Week 48 as Assessed by the Transitional Dyspnea Index (TDI)
units on a scaleAmbrisentanPlacebo
Change in Dyspnea Score at Week 48 as Assessed by the Transitional Dyspnea Index (TDI)-1.23 ± 3.74-0.84 ± 2.99
Statistical analysis
  • Ambrisentan vs Placebo · Wilcoxon (Mann-Whitney) · p = 0.793 (The p-value was based on a Wilcoxon rank sum test stratified by baseline pulmonary hypertension (Yes/No) and surgical lung biopsy was performed with definite or probable UIP based on core pathology review (Yes/No).) · Point estimate: 0.50 · 95% CI 0.00 to 1.00The point estimate and 95% confidence interval were based on the Hodges-Lehmann Estimate of treatment effect
SecondaryPercentage 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.

Time frame:
Up to 48 weeks
Reported as:
Number · percentage of participants
Percentage of Participants Who Developed PH on Study
percentage of participantsAmbrisentanPlacebo
Percentage of Participants Who Developed PH on Study0.72.1

Adverse events

Collected over Up to 48 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Ambrisentan—73/329 (22.2%)227/329 (69%)
Placebo—25/163 (15.3%)104/163 (63.8%)
Most frequent serious events
Showing 10 of 130
Most frequent serious events
EventAmbrisentanPlacebo
Idiopathic pulmonary fibrosisRespiratory, thoracic and mediastinal disorders20/3294/163
DyspnoeaRespiratory, thoracic and mediastinal disorders17/3292/163
PneumoniaInfections and infestations9/3292/163
HeadacheNervous system disorders5/3291/163
Acute respiratory failureRespiratory, thoracic and mediastinal disorders5/3291/163
Gastrooesophageal reflux diseaseGastrointestinal disorders2/3292/163
NasopharyngitisInfections and infestations2/3292/163
Alanine aminotransferase increasedInvestigations0/3292/163
Cardiac failure congestiveCardiac disorders4/3290/163
ConstipationGastrointestinal disorders4/3290/163
Most frequent other events
Showing 10 of 18
Most frequent other events
EventAmbrisentanPlacebo
Oedema peripheralGeneral disorders73/32914/163
Upper respiratory tract infectionRespiratory, thoracic and mediastinal disorders47/32918/163
HeadacheNervous system disorders47/32917/163
CoughRespiratory, thoracic and mediastinal disorders34/32920/163
DyspnoeaRespiratory, thoracic and mediastinal disorders40/32911/163
NasopharyngitisInfections and infestations37/32918/163
BronchitisInfections and infestations23/32915/163
FatigueGeneral disorders22/32914/163
Nasal congestionRespiratory, thoracic and mediastinal disorders27/3296/163
Respiratory tract infectionInfections and infestations9/32912/163

Baseline characteristics

Full Analysis Set: participants who were randomized and treated

Age, Continuous
Age, Continuous(years)AmbrisentanPlaceboTotal
Mean65.8 ± 7.466.1 ± 7.165.9 ± 7.3
Sex: Female, Male
Sex: Female, Male(Participants)AmbrisentanPlaceboTotal
Female8552137
Male244111355
Race/Ethnicity, Customized
Race/Ethnicity, Customized(participants)AmbrisentanPlaceboTotal
Black or African Heritage101
White293145438
Asian415
American Indian or Alaskan Native112
Other271643
Not Permitted303
Region of Enrollment
Region of Enrollment(participants)AmbrisentanPlaceboTotal
United States14162203
Canada251439
Australia221234
France211031
Germany17926
Brazil18624
Peru12618
Czech Republic10616
Israel8715
Italy11314
Belgium7613
Colombia8311
Mexico549
United Kingdom369
Spain718
Poland336
Switzerland516
Austria224
Chile314
Argentina123
Ireland101
Baseline Pulmonary Hypertension (PH) per interactive voice response system (IVRS)
Baseline Pulmonary Hypertension (PH) per interactive voice response system (IVRS)(participants)AmbrisentanPlaceboTotal
No293145438
Yes361854
Smoking status
Smoking status(participants)AmbrisentanPlaceboTotal
Never10553158
Current7512
Former217104321
Surgical lung biopsy (SLB) to Confirm Diagnosis of IPF (per IVRS)
Surgical lung biopsy (SLB) to Confirm Diagnosis of IPF (per IVRS)(participants)AmbrisentanPlaceboTotal
No17587262
Yes15476230
Disease duration
Disease duration(years)AmbrisentanPlaceboTotal
Mean1.13 ± 1.390.91 ± 1.191.06 ± 1.33

5 further baseline measures are reported on the registry.

08

Study locations

185 sites
  • University of Alabama at Birmingham Hospital
    Birmingham, Alabama 35294, United States
  • Pulmonary Associates
    Phoenix, Arizona 85006, United States
  • Scottsdale, Arizona 85258, United States
  • 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
  • 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
  • Emory University
    Atlanta, Georgia 30322, United States
  • University of Chicago
    Chicago, Illinois 60637, United States
  • Council Bluffs, Iowa 51503, United States
  • Kentuckiana Pulmonary Association
    Louisville, Kentucky 40202, United States
  • Louisville, Kentucky 40202, United States
  • 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
  • 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
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
  • 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
  • University of Pennsylvania Health Systems
    Philadelphia, Pennsylvania 19104, United States
  • Philadelphia, Pennsylvania 19140, 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
  • Medical University of South Carolina
    Charleston, South Carolina 29425, United States
  • Lexington, South Carolina 29072, United States
  • Spartanburg, South Carolina 29303, United States
  • 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
  • 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
  • Mar del Plata, Provincia de Buenos Aires B7602DCK, Argentina
  • 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
  • Concord, New South Wales 2139, Australia
  • Darlinghurst, New South Wales 2010, Australia
  • Chermside, Queensland 4032, Australia
  • Woodville, South Australia 5011, Australia
  • Hobart, Tasmania 7000, Australia
  • Parkville, Victoria 3050, Australia
  • Prahran, Victoria 3181, Australia
  • Perth, Western Australia 6000, Australia
  • 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
  • Calgary, Alberta T1Y6J4, Canada
  • Edmondton, Alberta T6G 2C8, Canada
  • Vancouver, British Columbia V5Z 1M9, Canada
  • Vancouver, British Columbia V6Z 1YP, Canada
  • St. Johns, Newfoundland and Labrador A1B 3V6, Canada
  • Montreal, Quebec H2W1T8, Canada
  • Sainte Foy, Quebec G1V 4G5, Canada
  • Toronto, M4X1104, Canada
  • Santiago, 7500691, Chile
  • Talcahuano, 4270918, Chile
  • Valparaiso, 2352499, Chile
  • Bogota, Colombia

Showing the first 100 of 185 sites across 22 countries.

09

References and documents

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. Erratum In: Ann Intern Med. 2014 May 6;160(9):658. 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 ↗
10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 8, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT00768300
Lead sponsor
Gilead Sciences
Responsible party
Sponsor
First posted
Oct 8, 2008
Start date
Dec 2008
Primary completion
Feb 2011
Completion
Feb 2011
Results posted
Apr 8, 2014
Last update
Apr 8, 2014

Study contacts

Ganesh Raghu, MD
study chair · University of Washington, Div. of Pulmonary and Critical Care Medicine Chair

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

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