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

Primary Purpose

Idiopathic Pulmonary Fibrosis, Pulmonary Hypertension

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ambrisentan
Placebo
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring Idiopathic Pulmonary Fibrosis, Pulmonary Hypertension, PH, IPF, Ambrisentan, ERA, Endothelin Receptor Antagonist, Cardiovascular

Eligibility Criteria

35 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Alabama at Birmingham
  • Mayo Clinic Arizona
  • University of California Davis
  • David Geffen School of Medicine UCLA
  • University of California San Diego Medical Center
  • University of California at San Francisco
  • Stanford University
  • University of Colorado Heatlh Sciences Center
  • Bay Area Chest Physicians
  • University of Florida
  • University of Miami Medical Center
  • Suncoast Lung Center
  • Sarasota Memorial Hospital
  • Cleveland Clinic Florida
  • Atlanta Institute for Medical Research
  • University of Chicago
  • Kentuckiana Pulmonary Association
  • Maine Medical Center
  • Johns Hopkins University School of Medicine
  • Tufts Medical Center
  • Brigham and Women's Hospital
  • Boston University Medical Center
  • Beth Israel Deacones Medical Center
  • University of Michigan Health Systems
  • Mayo Clinic Rochester
  • Washington University
  • Creighton University Center for Allergy & Asthma
  • Dartmouth Medical School
  • Albany Medical Center
  • Winthrop University Hospital
  • North Shore Health System
  • Mount Sinai School of Medicine
  • Columbia University
  • University of North Carolina at Chapel Hill
  • Duke University Medical Center
  • The Lindner Center for Research & Education at The Christ Hospital
  • University Hospitals of Cleveland Case Western
  • Cleveland Clinic Foundation
  • Ohio State University
  • Hospital of the University of Pennsylvania
  • Temple University School of Medicine
  • Alleghany General Hospital
  • University of Pittsburgh Cancer Institute
  • Medical University of South Carolina
  • Vanderbilt University Medical Center
  • University of Texas Southwestern
  • Baylor College of Medicine
  • University of Utah
  • Inova Heart Institiute and Vascular Institute
  • Virginia Commonwealth University Health System
  • Providence Everett Medical Center
  • St. Vincents Hospital
  • The Prince Charles Hospital
  • Royal Perth Hospital
  • Medizinische Universität Graz
  • Universitatsklinikum Innsbruck
  • Medizinische Universität Wien
  • Peter Loughheed Center- Calgary General Hospital
  • University of British Columbia
  • London Health Sciences Centre
  • Toronto General Hospital
  • Centre Hospitalier De L'Universite de Montreal
  • Sir Mortimer B. Davis Jewish General Center
  • Centre de Pneumologie de L'Hospital Laval
  • Evangelische Lungenklinik Berlin
  • Charite-Universitatsmedizin Berlin
  • Krankenhaus Donaustauf der LVA
  • Universitatsklinikum Freiburg
  • Universitat Greifswald
  • Medizinische Hochschule Hannover
  • Thorax Klinik
  • LMU Klinikum der Universitat
  • Azienda Ospedaliero Universitaria
  • Presidio Ospedaliero G.B. Morgagni
  • Unita Funzionale di Pneumologia e Fisiopatologia Respiratoria
  • Ospedale S.Giuseppe Fatebenefratelli
  • Azienda Ospedaliera di Padova
  • Instituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione
  • Policlinico Universitario Tor Vergata
  • Azienda Ospedaliera Universitaria Senese
  • Centro delle Interstiziopatie Polmonari e Malattie Rare del Polmone
  • Papworth Hospital NHS Foundation Trust
  • University Hospital Aintree
  • University College Hosptial
  • Royal Hallamshire Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ambrisentan

Placebo

Arm Description

Participants 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

Participants 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.

Outcomes

Primary Outcome Measures

Change From Baseline in Six-minute Walk Distance (6MWD).
The change from baseline in 6MWD at Week 16 (end of blinded treatment) was evaluated.

Secondary Outcome Measures

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.
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).
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.
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.
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.
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).
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.
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.
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.

Full Information

First Posted
April 8, 2009
Last Updated
May 5, 2014
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00879229
Brief Title
ARTEMIS-PH - Study of Ambrisentan in Subjects With Pulmonary Hypertension Associated With Idiopathic Pulmonary Fibrosis
Acronym
ARTEMIS-PH
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Terminated
Study Start Date
July 2009 (undefined)
Primary Completion Date
February 2011 (Actual)
Study Completion Date
February 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 evaluate the effectiveness and safety of ambrisentan in that patient population.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis, Pulmonary Hypertension
Keywords
Idiopathic Pulmonary Fibrosis, Pulmonary Hypertension, PH, IPF, Ambrisentan, ERA, Endothelin Receptor Antagonist, Cardiovascular

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ambrisentan
Arm Type
Experimental
Arm Description
Participants 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
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants 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.
Intervention Type
Drug
Intervention Name(s)
Ambrisentan
Other Intervention Name(s)
Letairis
Intervention Description
Ambrisentan (5 mg or 10 mg tablet) administered orally once daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to match ambrisentan administered orally once daily.
Primary Outcome Measure Information:
Title
Change From Baseline in Six-minute Walk Distance (6MWD).
Description
The change from baseline in 6MWD at Week 16 (end of blinded treatment) was evaluated.
Time Frame
Baseline to Week 16
Secondary Outcome Measure Information:
Title
Long-term Survival
Description
Long-term survival was assessed as a Kaplan-Meier (KM) estimate of the percent probability of survival, with censoring at Week 48.
Time Frame
Week 48
Title
Transition Dyspnea Index (TDI)
Description
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).
Time Frame
Baseline to Week 16
Title
Change From Baseline in WHO Functional Class
Description
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.
Time Frame
Baseline to Week 16
Title
Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted
Description
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.
Time Frame
Baseline to Week 16
Title
Change From Baseline in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP)
Description
Assessment of the the level of the amino acid fragment NT-proBNP is used to establish prognosis in cardiovascular disease.
Time Frame
Baseline to Week 16
Title
Change From Baseline in the Borg Dyspnea Index (BORG) Immediately Following Exercise
Description
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).
Time Frame
Baseline to Week 16
Title
Hemoglobin-corrected Diffusing Capacity for Carbon Monoxide (DLCO) Percent Predicted
Description
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.
Time Frame
Baseline to Week 16
Title
Change in Quality of Life (QOL) Score as Assessed by the Short-Form 36® (SF-36)
Description
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.
Time Frame
Baseline to Week 16
Title
Change in QOL Score as Assessed by the St. George's Respiratory Questionnaire (SRGQ)
Description
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.
Time Frame
Baseline to Week 16

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hunter Gillies, M.D.
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
University of California Davis
City
Davis
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
David Geffen School of Medicine UCLA
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California San Diego Medical Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
University of California at San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Colorado Heatlh Sciences Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Bay Area Chest Physicians
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
University of Miami Medical Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Suncoast Lung Center
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34233
Country
United States
Facility Name
Sarasota Memorial Hospital
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Atlanta Institute for Medical Research
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30030
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Kentuckiana Pulmonary Association
City
Louisville
State/Province
Kentucky
Country
United States
Facility Name
Maine Medical Center
City
Portland
State/Province
Maine
Country
United States
Facility Name
Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Boston University Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Beth Israel Deacones Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
University of Michigan Health Systems
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University
City
St Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Creighton University Center for Allergy & Asthma
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68131
Country
United States
Facility Name
Dartmouth Medical School
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
Facility Name
Albany Medical Center
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
North Shore Health System
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
University of North Carolina at Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
The Lindner Center for Research & Education at The Christ Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University Hospitals of Cleveland Case Western
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Hospital of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Temple University School of Medicine
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
Alleghany General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
12512
Country
United States
Facility Name
University of Pittsburgh Cancer Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
University of Texas Southwestern
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
Inova Heart Institiute and Vascular Institute
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Virginia Commonwealth University Health System
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Providence Everett Medical Center
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
St. Vincents Hospital
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
The Prince Charles Hospital
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
Medizinische Universität Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Universitatsklinikum Innsbruck
City
Innsbruck
Country
Austria
Facility Name
Medizinische Universität Wien
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
Peter Loughheed Center- Calgary General Hospital
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y 6J4
Country
Canada
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
London Health Sciences Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5W9
Country
Canada
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
Country
Canada
Facility Name
Centre Hospitalier De L'Universite de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
Facility Name
Sir Mortimer B. Davis Jewish General Center
City
Montreal
State/Province
Quebec
Country
Canada
Facility Name
Centre de Pneumologie de L'Hospital Laval
City
Sainte foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Facility Name
Evangelische Lungenklinik Berlin
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Charite-Universitatsmedizin Berlin
City
Berlin
Country
Germany
Facility Name
Krankenhaus Donaustauf der LVA
City
Donaustauf
ZIP/Postal Code
93093
Country
Germany
Facility Name
Universitatsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
79095
Country
Germany
Facility Name
Universitat Greifswald
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Thorax Klinik
City
Heidelberg
ZIP/Postal Code
66126
Country
Germany
Facility Name
LMU Klinikum der Universitat
City
Munchen
Country
Germany
Facility Name
Azienda Ospedaliero Universitaria
City
Catania
Country
Italy
Facility Name
Presidio Ospedaliero G.B. Morgagni
City
Forli
Country
Italy
Facility Name
Unita Funzionale di Pneumologia e Fisiopatologia Respiratoria
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Ospedale S.Giuseppe Fatebenefratelli
City
Milan
Country
Italy
Facility Name
Azienda Ospedaliera di Padova
City
Padova
Country
Italy
Facility Name
Instituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione
City
Palermo
Country
Italy
Facility Name
Policlinico Universitario Tor Vergata
City
Rome
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Senese
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Centro delle Interstiziopatie Polmonari e Malattie Rare del Polmone
City
Torino
ZIP/Postal Code
10043
Country
Italy
Facility Name
Papworth Hospital NHS Foundation Trust
City
Cambridge
ZIP/Postal Code
CB23 3RE
Country
United Kingdom
Facility Name
University Hospital Aintree
City
Liverpool
Country
United Kingdom
Facility Name
University College Hosptial
City
London
Country
United Kingdom
Facility Name
Royal Hallamshire Hospital
City
Sheffield
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
25613108
Citation
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.
Results Reference
derived

Learn more about this trial

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

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