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

Primary Purpose

Idiopathic Pulmonary Fibrosis

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, interstitial lung disease, ambrisentan

Eligibility Criteria

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

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

Sites / Locations

  • University of Alabama at Birmingham Hospital
  • Pulmonary Associates
  • David Geffen School of Medicine at UCLA(Harbor-UCLA Medical Center)
  • University of California, Davis
  • Stanford University
  • National Jewish Medical And Research Center
  • Bay Area Chest Physicians
  • University of Miami Miller School of Medicine
  • Emory University
  • University of Chicago
  • Kentuckiana Pulmonary Association
  • Mayo Clinic
  • Saint Lukes Foundation
  • Dartmouth Medical School
  • Pulmonary & Allergy Associates
  • Pulmonary And Critical Care Services, P.C.
  • Winthrop University Hospital
  • Columbia University Medical Center
  • Duke University Medical Center
  • The Cleveland Clinic Foundation
  • The Oregon Clinic, P.C.
  • University of Pennsylvania Health Systems
  • University of Pittsburgh
  • The Reading Hospital and Medical Center
  • Medical University of South Carolina
  • Hospital Virgen del Rocio
  • Complejo Asistencial Universitario de León

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ambrisentan

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
October 7, 2008
Last Updated
February 27, 2014
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT00768300
Brief Title
(ARTEMIS-IPF) Randomized, Placebo-Controlled Study to Evaluate Safety and Effectiveness of Ambrisentan in IPF
Acronym
ARTEMIS-IPF
Official Title
ARTEMIS-IPF: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects With Early Idiopathic Pulmonary Fibrosis (IPF)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2014
Overall Recruitment Status
Terminated
Why Stopped
Lack of efficacy
Study Start Date
December 2008 (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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
idiopathic pulmonary fibrosis, interstitial lung disease, ambrisentan

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
494 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ambrisentan
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Ambrisentan
Other Intervention Name(s)
Letairis®
Intervention Description
Ambrisentan (5mg or 10 mg tablet) was administered orally once daily.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo to match ambrisentan was administered orally once daily.
Primary Outcome Measure Information:
Title
Time to Death or Disease (IPF) Progression.
Description
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 Outcome Measure Information:
Title
Proportion of Participants With No Disease Progression or Death at 48 Weeks
Description
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
Title
Change in FVC % Predicted at Week 48
Description
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
Title
Change in DLCO % Predicted at Week 48
Description
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
Title
Change in 6MWT at Week 48
Description
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
Title
Change in Quality of Life (QOL) Score at Week 48 as Assessed by the Short-Form 36® (SF-36)
Description
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
Title
Change in Quality of Life (QOL) Score at Week 48 as Assessed by the St. George's Respiratory Questionnaire (SGRQ)
Description
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
Title
Change in Dyspnea Score at Week 48 as Assessed by the Transitional Dyspnea Index (TDI)
Description
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
Title
Percentage of Participants Who Developed PH on Study
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ganesh Raghu, MD
Organizational Affiliation
University of Washington, Div. of Pulmonary and Critical Care Medicine Chair
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Pulmonary Associates
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
David Geffen School of Medicine at UCLA(Harbor-UCLA Medical Center)
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
University of California, Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
City
San Diego
State/Province
California
ZIP/Postal Code
92103-8373
Country
United States
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
National Jewish Medical And Research Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
City
Newark
State/Province
Delaware
ZIP/Postal Code
19713
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 Miami Miller School of Medicine
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
City
Council Bluffs
State/Province
Iowa
ZIP/Postal Code
51503
Country
United States
Facility Name
Kentuckiana Pulmonary Association
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Saint Lukes Foundation
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Dartmouth Medical School
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
03756
Country
United States
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
City
Piscataway
State/Province
New Jersey
ZIP/Postal Code
08854
Country
United States
Facility Name
Pulmonary & Allergy Associates
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07091
Country
United States
Facility Name
Pulmonary And Critical Care Services, P.C.
City
Albany
State/Province
New York
ZIP/Postal Code
12205
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
The Cleveland Clinic Foundation
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44795
Country
United States
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
The Oregon Clinic, P.C.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97220
Country
United States
Facility Name
University of Pennsylvania Health Systems
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
Facility Name
University of Pittsburgh
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
The Reading Hospital and Medical Center
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19611
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
City
Lexington
State/Province
South Carolina
ZIP/Postal Code
29072
Country
United States
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
City
McKinney
State/Province
Texas
ZIP/Postal Code
75069
Country
United States
City
Provo
State/Province
Utah
ZIP/Postal Code
84604
Country
United States
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
City
Mar del Plata
State/Province
Provincia de Buenos Aires
ZIP/Postal Code
B7602DCK
Country
Argentina
City
Buenos Aires
ZIP/Postal Code
C1425DES
Country
Argentina
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1181ACH
Country
Argentina
City
Ciudad Autonoma de Buenos Aires
ZIP/Postal Code
C1280AEB
Country
Argentina
City
Mar del Plata, Buenos Aires
ZIP/Postal Code
B7602DCK
Country
Argentina
City
San Miguel de Tucuman
ZIP/Postal Code
T4000HXU
Country
Argentina
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
City
Woodville
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
City
Hobart
State/Province
Tasmania
ZIP/Postal Code
7000
Country
Australia
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
City
Prahran
State/Province
Victoria
ZIP/Postal Code
3181
Country
Australia
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
City
Graz
ZIP/Postal Code
8036
Country
Austria
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
City
Linz
ZIP/Postal Code
4020
Country
Austria
City
Wien
ZIP/Postal Code
1090
Country
Austria
City
Anderlecht
ZIP/Postal Code
1070
Country
Belgium
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
City
Belo Horizonte
ZIP/Postal Code
30430-1
Country
Brazil
City
Florianopolis
ZIP/Postal Code
88040-970
Country
Brazil
City
Goiania
ZIP/Postal Code
74605-050
Country
Brazil
City
Porto Alegre
ZIP/Postal Code
90035-074
Country
Brazil
City
Porto Alegre
ZIP/Postal Code
90610-000
Country
Brazil
City
Porto Alegre
ZIP/Postal Code
91350-200
Country
Brazil
City
Rio de Janeiro
ZIP/Postal Code
21949-900
Country
Brazil
City
Santo Andre
ZIP/Postal Code
09060-650
Country
Brazil
City
Sao Paolo
ZIP/Postal Code
04023-062
Country
Brazil
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T1Y6J4
Country
Canada
City
Edmondton
State/Province
Alberta
ZIP/Postal Code
T6G 2C8
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1YP
Country
Canada
City
St. Johns
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W1T8
Country
Canada
City
Sainte Foy
State/Province
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
City
Toronto
ZIP/Postal Code
M4X1104
Country
Canada
City
Santiago
ZIP/Postal Code
7500691
Country
Chile
City
Talcahuano
ZIP/Postal Code
4270918
Country
Chile
City
Valparaiso
ZIP/Postal Code
2352499
Country
Chile
City
Bogota
Country
Colombia
City
Floridablanca
Country
Colombia
City
Brno
ZIP/Postal Code
625-00
Country
Czech Republic
City
Hradec Kralove
ZIP/Postal Code
500 05
Country
Czech Republic
City
Jihlava
ZIP/Postal Code
586 33
Country
Czech Republic
City
Liberec
ZIP/Postal Code
460 63
Country
Czech Republic
City
Olomouc
ZIP/Postal Code
775-20
Country
Czech Republic
City
Plzen
ZIP/Postal Code
305 99
Country
Czech Republic
City
Lille
ZIP/Postal Code
59037
Country
France
City
Marseille
ZIP/Postal Code
13009
Country
France
City
Montpellier
ZIP/Postal Code
34295
Country
France
City
Nice
ZIP/Postal Code
06002
Country
France
City
Paris
ZIP/Postal Code
75015
Country
France
City
Paris
ZIP/Postal Code
75018
Country
France
City
Pessac
ZIP/Postal Code
33604
Country
France
City
Rennes
ZIP/Postal Code
35033
Country
France
City
Tours
ZIP/Postal Code
37044
Country
France
City
Berlin
ZIP/Postal Code
10117
Country
Germany
City
Berlin
ZIP/Postal Code
D-13125
Country
Germany
City
Coswig
ZIP/Postal Code
01640
Country
Germany
City
Donaustauf
ZIP/Postal Code
93093
Country
Germany
City
Essen
ZIP/Postal Code
D-45239
Country
Germany
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
City
Greifswald
ZIP/Postal Code
D-17475
Country
Germany
City
Heidelberg
ZIP/Postal Code
69126
Country
Germany
City
Lowenstein
ZIP/Postal Code
D-74245
Country
Germany
City
Munchen
ZIP/Postal Code
81377
Country
Germany
City
Dublin
ZIP/Postal Code
7
Country
Ireland
City
Ashkelon
ZIP/Postal Code
78306
Country
Israel
City
Beer-Sheva
ZIP/Postal Code
84101
Country
Israel
City
Haifa
ZIP/Postal Code
31096
Country
Israel
City
Haifa
ZIP/Postal Code
34362
Country
Israel
City
Jerusalem
ZIP/Postal Code
91031
Country
Israel
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
City
Petach Tikva
ZIP/Postal Code
49100
Country
Israel
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
City
Tel-Hashomer
ZIP/Postal Code
52621
Country
Israel
City
Catania
ZIP/Postal Code
95123
Country
Italy
City
Forlì
ZIP/Postal Code
47100
Country
Italy
City
Milano
ZIP/Postal Code
20123
Country
Italy
City
Milano
ZIP/Postal Code
20132
Country
Italy
City
Modena
ZIP/Postal Code
41100
Country
Italy
City
Napoli
ZIP/Postal Code
80131
Country
Italy
City
Padova
ZIP/Postal Code
35128
Country
Italy
City
Palermo
ZIP/Postal Code
90127
Country
Italy
City
Roma
ZIP/Postal Code
00133
Country
Italy
City
Siena
ZIP/Postal Code
53100
Country
Italy
City
Torino
ZIP/Postal Code
10043
Country
Italy
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44670
Country
Mexico
City
Monterrey
State/Province
Nuevo Leon
ZIP/Postal Code
64718
Country
Mexico
City
Huixquilucan Edo. de Mexico
ZIP/Postal Code
52763
Country
Mexico
City
Mexico City, DF
ZIP/Postal Code
14080
Country
Mexico
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
City
Zapopan, Jalisco
ZIP/Postal Code
45200
Country
Mexico
City
Almelo
ZIP/Postal Code
7609 PP
Country
Netherlands
City
Callao
ZIP/Postal Code
Callao 02
Country
Peru
City
Lima
ZIP/Postal Code
L31
Country
Peru
City
Lima
ZIP/Postal Code
L33
Country
Peru
City
Lima
ZIP/Postal Code
Lima 01
Country
Peru
City
Lima
ZIP/Postal Code
Lima 27
Country
Peru
City
Lima
ZIP/Postal Code
Lima 41
Country
Peru
City
Bydgoszcz
ZIP/Postal Code
85-681
Country
Poland
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
City
Cadiz
State/Province
Andalucia
ZIP/Postal Code
11009
Country
Spain
Facility Name
Hospital Virgen del Rocio
City
Sevilla
State/Province
Andalucia
ZIP/Postal Code
41011
Country
Spain
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33006
Country
Spain
Facility Name
Complejo Asistencial Universitario de León
City
Leon
State/Province
Castilla
ZIP/Postal Code
24080
Country
Spain
City
Pontevedra
State/Province
Galicia
ZIP/Postal Code
36071
Country
Spain
City
Pozuelo de Alarcon
State/Province
Madrid, Communidad de
ZIP/Postal Code
28223
Country
Spain
City
Badalona
ZIP/Postal Code
08916
Country
Spain
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
City
Madrid
ZIP/Postal Code
28007
Country
Spain
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S10 2JF
Country
United Kingdom
City
Chertsey
State/Province
Surrey
ZIP/Postal Code
KT16 0PZ
Country
United Kingdom
City
Cambridge
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
City
Chelmsford
ZIP/Postal Code
CM1 7ET
Country
United Kingdom
City
Edinburgh
ZIP/Postal Code
EH16 4SA
Country
United Kingdom
City
Glasgow
ZIP/Postal Code
G4 0SF
Country
United Kingdom
City
Liverpool
ZIP/Postal Code
L9 7AL
Country
United Kingdom
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
City
London
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
City
Mancesheter
ZIP/Postal Code
M23 9LT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
23648946
Citation
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.
Results Reference
result
PubMed Identifier
24717624
Citation
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.
Results Reference
derived
PubMed Identifier
24177001
Citation
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.
Results Reference
derived

Learn more about this trial

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

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