(ARTEMIS-IPF) Randomized, Placebo-Controlled Study to Evaluate Safety and Effectiveness of Ambrisentan in IPF (ARTEMIS-IPF)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00768300|
Recruitment Status : Terminated (Lack of efficacy)
First Posted : October 8, 2008
Results First Posted : April 8, 2014
Last Update Posted : April 8, 2014
- Study Details
- Tabular View
- Study Results
- How to Read a Study Record
|Condition or disease||Intervention/treatment||Phase|
|Idiopathic Pulmonary Fibrosis||Drug: Ambrisentan Drug: Placebo||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||494 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|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 Start Date :||December 2008|
|Actual Primary Completion Date :||February 2011|
|Actual Study Completion Date :||February 2011|
Ambrisentan (5mg or 10 mg tablet) was administered orally once daily.
Other Name: Letairis®
|Placebo Comparator: Placebo||
Placebo to match ambrisentan was administered orally once daily.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||40 Years to 80 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00768300
|Study Chair:||Ganesh Raghu, MD||University of Washington, Div. of Pulmonary and Critical Care Medicine Chair|
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Gilead Sciences|
|Other Study ID Numbers:||
|First Posted:||October 8, 2008 Key Record Dates|
|Results First Posted:||April 8, 2014|
|Last Update Posted:||April 8, 2014|
|Last Verified:||February 2014|
idiopathic pulmonary fibrosis
interstitial lung disease
Idiopathic Pulmonary Fibrosis
Lung Diseases, Interstitial
Respiratory Tract Diseases