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

February 27, 2014 updated by: Gilead Sciences

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
494

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1425DES
      • Ciudad Autonoma de Buenos Aires, Argentina, C1280AEB
      • Ciudad Autonoma de Buenos Aires, Argentina, C1181ACH
      • Mar del Plata, Buenos Aires, Argentina, B7602DCK
      • San Miguel de Tucuman, Argentina, T4000HXU
    • Provincia de Buenos Aires
      • Mar del Plata, Provincia de Buenos Aires, Argentina, B7602DCK
  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2139
      • Darlinghurst, New South Wales, Australia, 2010
    • Queensland
      • Chermside, Queensland, Australia, 4032
    • South Australia
      • Woodville, South Australia, Australia, 5011
    • Tasmania
      • Hobart, Tasmania, Australia, 7000
    • Victoria
      • Parkville, Victoria, Australia, 3050
      • Prahran, Victoria, Australia, 3181
    • 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, 90610-000
      • Porto Alegre, Brazil, 91350-200
      • Porto Alegre, Brazil, 90035-074
      • Rio de Janeiro, Brazil, 21949-900
      • Santo Andre, Brazil, 09060-650
      • Sao Paolo, Brazil, 04023-062
  • Canada
      • Toronto, Canada, M4X1104
    • Alberta
      • Calgary, Alberta, Canada, T1Y6J4
      • Edmondton, Alberta, Canada, T6G 2C8
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
      • Vancouver, British Columbia, Canada, V6Z 1YP
    • Newfoundland and Labrador
      • St. Johns, Newfoundland and Labrador, Canada, A1B 3V6
    • Quebec
      • Montreal, Quebec, Canada, H2W1T8
      • Sainte Foy, Quebec, Canada, G1V 4G5
  • 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, 75018
      • Paris, France, 75015
      • 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, 91120
      • Jerusalem, Israel, 91031
      • Petach Tikva, Israel, 49100
      • Rehovot, Israel, 76100
      • Tel Aviv, Israel, 64239
      • Tel-Hashomer, Israel, 52621
  • Italy
      • Catania, Italy, 95123
      • Forlì, Italy, 47100
      • Milano, Italy, 20132
      • Milano, Italy, 20123
      • Modena, Italy, 41100
      • Napoli, Italy, 80131
      • Padova, Italy, 35128
      • Palermo, Italy, 90127
      • Roma, Italy, 00133
      • Siena, Italy, 53100
      • Torino, Italy, 10043
  • Mexico
      • Huixquilucan Edo. de Mexico, Mexico, 52763
      • Mexico City, DF, Mexico, 14080
      • Monterrey, Mexico, 64460
      • Zapopan, Jalisco, Mexico, 45200
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44670
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64718
  • Netherlands
      • Almelo, Netherlands, 7609 PP
  • Peru
      • Callao, Peru, Callao 02
      • Lima, Peru, Lima 27
      • Lima, Peru, Lima 41
      • Lima, Peru, Lima 01
      • Lima, Peru, L31
      • Lima, Peru, L33
  • Poland
      • Bydgoszcz, Poland, 85-681
      • Lodz, Poland, 90-153
  • Spain
      • Badalona, Spain, 08916
      • Barcelona, Spain, 08036
      • Madrid, Spain, 28007
    • Andalucia
      • Cadiz, Andalucia, Spain, 11009
      • Sevilla, Andalucia, Spain, 41011
        • Hospital Virgen Del Rocio
    • Asturias
      • Oviedo, Asturias, Spain, 33006
    • Castilla
      • Leon, Castilla, Spain, 24080
        • Complejo Asistencial Universitario de León
    • Galicia
      • Pontevedra, Galicia, Spain, 36071
    • Madrid, Communidad de
      • Pozuelo de Alarcon, Madrid, Communidad de, Spain, 28223
  • Switzerland
      • Basel, Switzerland, 4031
      • Bern, Switzerland, 3010
      • Lausanne, Switzerland, 1011
  • United Kingdom
      • 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, NW1 2PG
      • London, United Kingdom, SW3 6NP
      • Mancesheter, United Kingdom, M23 9LT
    • South Yorkshire
      • Sheffield, South Yorkshire, United Kingdom, S10 2JF
    • Surrey
      • Chertsey, Surrey, United Kingdom, KT16 0PZ
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama At Birmingham Hospital
    • Arizona
      • Phoenix, Arizona, United States, 85006
        • Pulmonary Associates
      • Scottsdale, Arizona, United States, 85258
    • California
      • Los Angeles, California, United States, 90095
        • David Geffen School of Medicine at UCLA(Harbor-UCLA Medical Center)
      • Sacramento, California, United States, 95817
        • University of California, Davis
      • San Diego, California, United States, 92103-8373
      • San Francisco, California, United States, 94143
      • Stanford, California, United States, 94305
        • Stanford University
    • Colorado
      • Denver, Colorado, United States, 80206
        • National Jewish Medical and Research Center
    • Delaware
      • Newark, Delaware, United States, 19713
    • Florida
      • Clearwater, Florida, United States, 33756
        • Bay Area Chest Physicians
      • Miami, Florida, United States, 33136
        • University of Miami Miller School of Medicine
      • Tampa, Florida, United States, 33606
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University
    • Illinois
      • Chicago, Illinois, United States, 60637
        • University of Chicago
    • Iowa
      • Council Bluffs, Iowa, United States, 51503
    • Kentucky
      • Louisville, Kentucky, United States, 40202
      • Louisville, Kentucky, United States, 40202
        • Kentuckiana Pulmonary Association
    • Maryland
      • Baltimore, Maryland, United States, 21201
      • Baltimore, Maryland, United States, 21205
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
      • Boston, Massachusetts, United States, 02115
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Saint Lukes Foundation
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Dartmouth Medical School
    • New Jersey
      • New Brunswick, New Jersey, United States, 08903
      • Piscataway, New Jersey, United States, 08854
      • Summit, New Jersey, United States, 07091
        • Pulmonary & Allergy Associates
    • New York
      • Albany, New York, United States, 12205
        • Pulmonary And Critical Care Services, P.C.
      • Mineola, New York, United States, 11501
        • Winthrop University Hospital
      • New Hyde Park, New York, United States, 11040
      • New York, New York, United States, 10032
        • Columbia University Medical Center
      • New York, New York, United States, 10029
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center
    • Ohio
      • Cincinnati, Ohio, United States, 45267
      • Cleveland, Ohio, United States, 44795
        • The Cleveland Clinic Foundation
      • Columbus, Ohio, United States, 43215
    • Oregon
      • Portland, Oregon, United States, 97220
        • The Oregon Clinic, P.C.
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19140
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania Health Systems
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh
      • Pittsburgh, Pennsylvania, United States, 15212
      • Reading, Pennsylvania, United States, 19611
        • The Reading Hospital and Medical Center
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
      • Lexington, South Carolina, United States, 29072
      • Spartanburg, South Carolina, United States, 29303
    • Tennessee
      • Nashville, Tennessee, United States, 37232
    • Texas
      • Houston, Texas, United States, 77030
      • McKinney, Texas, United States, 75069
    • Utah
      • Provo, Utah, United States, 84604
      • Salt Lake City, Utah, United States, 84108
    • Virginia
      • Charlottesville, Virginia, United States, 22908
      • Falls Church, Virginia, United States, 22042
      • Lynchburg, Virginia, United States, 24501
    • Washington
      • Everett, Washington, United States, 98201
      • Seattle, Washington, United States, 98195

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
PLACEBO_COMPARATOR: Placebo
Drug: Placebo
Placebo to match ambrisentan was administered orally once daily.
EXPERIMENTAL: Ambrisentan
Drug: Ambrisentan
Ambrisentan (5mg or 10 mg tablet) was administered orally once daily.
Other Names:
  • Letairis®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Time to Death or Disease (IPF) Progression.
Time Frame: Up to 48 months

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
Up to 48 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of Participants With No Disease Progression or Death at 48 Weeks
Time Frame: Baseline and Week 48
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.
Baseline and Week 48
Change in FVC % Predicted at Week 48
Time Frame: Baseline and 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.
Baseline and Week 48
Change in DLCO % Predicted at Week 48
Time Frame: Baseline and 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.
Baseline and Week 48
Change in 6MWT at Week 48
Time Frame: Baseline and 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.
Baseline and Week 48
Change in Quality of Life (QOL) Score at Week 48 as Assessed by the Short-Form 36® (SF-36)
Time Frame: Baseline and Week 48
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.
Baseline and Week 48
Change in Quality of Life (QOL) Score at Week 48 as Assessed by the St. George's Respiratory Questionnaire (SGRQ)
Time Frame: Baseline and Week 48
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.
Baseline and Week 48
Change in Dyspnea Score at Week 48 as Assessed by the Transitional Dyspnea Index (TDI)
Time Frame: Baseline and Week 48
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.
Baseline and Week 48
Percentage of Participants Who Developed PH on Study
Time Frame: Up to 48 weeks
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.
Up to 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gilead Sciences

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Chair: Ganesh Raghu, MD, University of Washington, Div. of Pulmonary and Critical Care Medicine Chair

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2008

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2011

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 7, 2008

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 7, 2008

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 8, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 27, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GS-US-231-0101

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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