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Idiopathic Pulmonary FibrosisPhase 3ARTEMIS-PHNCT00879229

ARTEMIS-PH - Study of Ambrisentan in Subjects With Pulmonary Hypertension Associated With Idiopathic Pulmonary Fibrosis

A Phase 3 study testing Ambrisentan in people with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension, run by Gilead Sciences at 85 sites in 7 countries.

Terminated

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

Official record
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Trial summary

Ambrisentan is an endothelin receptor antagonist used for the treatment of pulmonary hypertension (PH). Based on research suggesting a role for endothelin-1 in the pathogenesis of idiopathic pulmonary fibrosis (IPF) and the poor prognosis for patients with IPF who are also diagnosed with PH, this study was designed to… Read more about this study

Who is it for?
Ages 35 to 80 years
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
40 participants
Where
85 sitesin 7 countries
Study dates
Jul 2009to 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 35 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Selected Inclusion Criteria:

  • Weight ≥ 40 kg at screening
  • Diagnosis of IPF based on modified American Thoracic Society-European Respiratory Society guidelines
  • Diagnosis of PH based on the following hemodynamic requirements: mean pulmonary artery pressure (mPAP ≥ 25 mm Hg; pulmonary vascular resistance > 240 dyne.sec/cm^5; pulmonary capillary wedge pressure or left ventricular end-diastolic pressure ≤ 15 mm Hg
  • Forced vital capacity (FVC) ≥ 40%
  • Able to walk at least 50 meters during two 6-minute walk tests
  • If receiving calcium channel blockers, low-dose oral corticosteroids, immunosuppressive, cytoxic, or antifibrotic drugs dose must have been stable.

Selected Exclusion Criteria:

  • Diagnosis of PH primarily due to an etiology other than IPF
  • Surgical lung biopsy diagnosis other than Usual Interstitial Pneumonia
  • Other known cause of interstitial lung disease
  • Evidence of significant obstructive lung disease
  • Recent hospitalization for an acute exacerbation of IPF
  • Recent active pulmonary or upper respiratory tract infection
  • Left ventricular ejection fraction < 40%
  • Serum creatinine ≥ 2.5 mg/dL
  • Required hemodialysis, peritoneal dialysis, or hemofiltration
  • Female subject who was pregnant or breastfeeding
  • Recent treatment for PH with an endothelin receptor antagonist (ERA), phosphodiesterase type 5 inhibitor, or prostacyclin derivative
  • Recent treatment with high dose oral corticosteroids
  • Recent treatment (within 4 weeks prior to screening) with imatinib mesylate (Gleevec)
  • Alanine aminotransferase or aspartate aminotransferase lab value that was greater than 1.5 x the upper limit of the normal range
  • Discontinued other ERA treatment for any adverse reaction other than those associated with liver function test abnormalities

Trial locations and contacts

85 sites in 7 countries.

85 sites in 7 countries

United States51 sites

  • Albany Medical Center

    Albany, New York, 12208

  • University of Michigan Health Systems

    Ann Arbor, Michigan, 48109

  • University of Colorado Heatlh Sciences Center

    Aurora, Colorado, 80045

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21205

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Boston University Medical Center

    Boston, Massachusetts, 02118

  • Beth Israel Deacones Medical Center

    Boston, Massachusetts, 02215

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina

  • University of Chicago

    Chicago, Illinois, 60637

  • The Lindner Center for Research & Education at The Christ Hospital

    Cincinnati, Ohio, 45219

  • Bay Area Chest Physicians

    Clearwater, Florida, 33756

  • University Hospitals of Cleveland Case Western

    Cleveland, Ohio, 44106

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Ohio State University

    Columbus, Ohio, 43210

  • University of Texas Southwestern

    Dallas, Texas, 75390

  • University of California Davis

    Davis, California, 95817

  • Atlanta Institute for Medical Research

    Decatur, Georgia, 30030

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Providence Everett Medical Center

    Everett, Washington, 98201

  • Inova Heart Institiute and Vascular Institute

    Falls Church, Virginia, 22042

  • University of Florida

    Gainesville, Florida, 32610

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Dartmouth Medical School

    Lebanon, New Hampshire, 03756

  • David Geffen School of Medicine UCLA

    Los Angeles, California, 90095

  • Kentuckiana Pulmonary Association

    Louisville, Kentucky

  • University of Miami Medical Center

    Miami, Florida, 33136

  • Winthrop University Hospital

    Mineola, New York, 11501

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • North Shore Health System

    New Hyde Park, New York, 11040

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • Columbia University

    New York, New York, 10032

  • Creighton University Center for Allergy & Asthma

    Omaha, Nebraska, 68131

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Temple University School of Medicine

    Philadelphia, Pennsylvania, 19140

  • Alleghany General Hospital

    Pittsburgh, Pennsylvania, 12512

  • University of Pittsburgh Cancer Institute

    Pittsburgh, Pennsylvania, 15213

  • Maine Medical Center

    Portland, Maine

  • Virginia Commonwealth University Health System

    Richmond, Virginia, 23298

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • University of Utah

    Salt Lake City, Utah, 84108

  • University of California San Diego Medical Center

    San Diego, California, 92103

  • University of California at San Francisco

    San Francisco, California, 94143

  • Suncoast Lung Center

    Sarasota, Florida, 34233

  • Sarasota Memorial Hospital

    Sarasota, Florida, 34239

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259

  • Washington University

    St Louis, Missouri, 63110

  • Stanford University

    Stanford, California, 94305

  • Cleveland Clinic Florida

    Weston, Florida, 33331

Other trials in United States

Italy9 sites

  • Azienda Ospedaliero Universitaria

    Catania

  • Presidio Ospedaliero G.B. Morgagni

    Forlì

  • Ospedale S.Giuseppe Fatebenefratelli

    Milan

  • Unita Funzionale di Pneumologia e Fisiopatologia Respiratoria

    Milan, 20132

  • Azienda Ospedaliera di Padova

    Padova

  • Instituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione

    Palermo

  • Policlinico Universitario Tor Vergata

    Rome

  • Azienda Ospedaliera Universitaria Senese

    Siena, 53100

  • Centro delle Interstiziopatie Polmonari e Malattie Rare del Polmone

    Torino, 10043

Other trials in Italy

Germany8 sites

  • Evangelische Lungenklinik Berlin

    Berlin, 13125

  • Charite-Universitatsmedizin Berlin

    Berlin

  • Krankenhaus Donaustauf der LVA

    Donaustauf, 93093

  • Universitatsklinikum Freiburg

    Freiburg im Breisgau, 79095

  • Universitat Greifswald

    Greifswald, 17475

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Thorax Klinik

    Heidelberg, 66126

  • LMU Klinikum der Universitat

    München

Other trials in Germany

Canada7 sites

  • Peter Loughheed Center- Calgary General Hospital

    Calgary, Alberta, T1Y 6J4

  • London Health Sciences Centre

    London, Ontario, N6A 5W9

  • Centre Hospitalier De L'Universite de Montreal

    Montreal, Quebec, H2W 1T8

  • Sir Mortimer B. Davis Jewish General Center

    Montreal, Quebec

  • Centre de Pneumologie de L'Hospital Laval

    Sainte-Foy, Quebec, G1V 4G5

  • Toronto General Hospital

    Toronto, Ontario

  • University of British Columbia

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

United Kingdom4 sites

  • Papworth Hospital NHS Foundation Trust

    Cambridge, CB23 3RE

  • University Hospital Aintree

    Liverpool

  • University College Hosptial

    London

  • Royal Hallamshire Hospital

    Sheffield

Other trials in United Kingdom

Australia3 sites

  • The Prince Charles Hospital

    Chermside, Queensland, 4032

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • St. Vincents Hospital

    Sydney, New South Wales, 2010

Other trials in Australia

Austria3 sites

  • Medizinische Universität Graz

    Graz, 8036

  • Universitatsklinikum Innsbruck

    Innsbruck

  • Medizinische Universität Wien

    Vienna, 1090

Other trials in Austria

About this study

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects With Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension

Ambrisentan is an endothelin receptor antagonist used for the treatment of pulmonary hypertension (PH). Based on research suggesting a role for endothelin-1 in the pathogenesis of idiopathic pulmonary fibrosis (IPF) and the poor prognosis for patients with IPF who are also diagnosed with PH, this study was designed to evaluate the effectiveness and safety of ambrisentan in that patient population.

Being tested
Ambrisentan, Placebo
Keywords
Idiopathic Pulmonary Fibrosis, Pulmonary Hypertension, PH, IPF, Ambrisentan, ERA, Endothelin Receptor Antagonist, Cardiovascular
Medical subject headings
Idiopathic Pulmonary Fibrosis, Hypertension, Pulmonary

What participants receive

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

  • AmbrisentanDrug

    Also called Letairis

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

  • PlaceboDrug

    Placebo to match ambrisentan administered orally once daily.

Study groups in NCT00879229
Study groupRoleWhat they receive
AmbrisentanExperimentalParticipants were randomized to receive ambrisentan treatment at an initial dose of 5 mg for 4 weeks, followed by ambrisentan at the target dose of 10 mg for an additional 52 weeks
Receives: Drug: Ambrisentan
PlaceboPlacebo comparatorParticipants were randomized to receive placebo to match ambrisentan for 48 weeks, then transition to ambrisentan treatment at the initial dose of 5 mg for 4 weeks, followed by ambrisentan at the target dose of 10 mg for an additional 4 weeks.
Receives: Drug: Ambrisentan; Drug: Placebo

What is being measured

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

  1. Change From Baseline in Six-minute Walk Distance (6MWD).

    The change from baseline in 6MWD at Week 16 (end of blinded treatment) was evaluated.

    Measured: Baseline to Week 16

Secondary outcomes (9)

  1. Long-term Survival

    Long-term survival was assessed as a Kaplan-Meier (KM) estimate of the percent probability of survival, with censoring at Week 48.

    Measured: Week 48

  2. Transition Dyspnea Index (TDI)

    The change in TDI at Week 16 (end of blinded treatment) was evaluated. TDI measures the change from the baseline characteristic "Baseline Dyspnea Index." The TDI range is -9 to +9 (worst to best; 0 = no change).

    Measured: Baseline to Week 16

  3. Change From Baseline in WHO Functional Class

    WHO functional class rates severity of pulmonary hypertension, with 4 categories on a scale of 1 to 4 with the worst category being 4. Change is represented as an increase ("+1: Improved"), decrease ("-1: Deteriorated"), or no change ("0: No change") on the scale.

    Measured: Baseline to Week 16

  4. Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted

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

    Measured: Baseline to Week 16

  5. Change From Baseline in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP)

    Assessment of the the level of the amino acid fragment NT-proBNP is used to establish prognosis in cardiovascular disease.

    Measured: Baseline to Week 16

  6. Change From Baseline in the Borg Dyspnea Index (BORG) Immediately Following Exercise

    Borg Dyspnea Index is a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness).

    Measured: Baseline to Week 16

  7. Hemoglobin-corrected Diffusing Capacity for Carbon Monoxide (DLCO) Percent Predicted

    DLCO is a pulmonary function test, and measures the partial pressure difference between inspired and expired carbon monoxide. DLCO% predicted is defined as DLCO% of the patient divided by the average DLCO% in the population for any person of similar age, sex and body composition.

    Measured: Baseline to Week 16

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

    Each SF-36 score is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. An increase in score indicates an improvement in health state.

    Measured: Baseline to Week 16

  9. Change in QOL Score as Assessed by the St. George's Respiratory Questionnaire (SRGQ)

    The SRGQ is designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Patients respond to questions about symptoms (frequency \& severity) and impact components (social functioning and psychological disturbances resulting from airways disease). Scores range from 0 to 100, with higher scores indicating more limitations.

    Measured: Baseline to Week 16

Timeline

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

  1. First posted9 Apr 2009 (estimated)
  2. Study startJul 2009
  3. Primary completionFeb 2011
  4. Study completionFeb 2011

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00879229
Sponsor's protocol ID
GS-US-300-0128
Acronym
ARTEMIS-PH
Status last verified
May 2014
First submitted
8 Apr 2009
Last updated
15 May 2014
Data monitoring committee
Yes

Publications

  • Ruocco G, Cekorja B, Rottoli P, Refini RM, Pellegrini M, Di Tommaso C, Del Castillo G, Franci B, Nuti R, Palazzuoli A. Role of BNP and echo measurement for pulmonary hypertension recognition in patients with interstitial lung disease: An algorithm application model. Respir Med. 2015 Mar;109(3):406-15. doi: 10.1016/j.rmed.2014.12.011. Epub 2015 Jan 3.

    PubMed 25613108

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ambrisentan in people with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension, run by Gilead Sciences at 85 sites in 7 countries.

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

Who may be eligible to take part?

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 15 May 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 85 sites in United States, Italy, Germany, Canada, United Kingdom and 2 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 22 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?

Change From Baseline in Six-minute Walk Distance (6MWD). (time frame: Baseline to Week 16). 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 NCT00879229, which also lists 1 linked publication.

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 15 May 2014.

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