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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT00768300




Registration number
NCT00768300
Ethics application status
Date submitted
7/10/2008
Date registered
8/10/2008
Date last updated
8/04/2014

Titles & IDs
Public title
(ARTEMIS-IPF) Randomized, Placebo-Controlled Study to Evaluate Safety and Effectiveness of Ambrisentan in IPF
Scientific 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)
Secondary ID [1] 0 0
GS-US-231-0101
Universal Trial Number (UTN)
Trial acronym
ARTEMIS-IPF
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Other respiratory disorders / diseases
Inflammatory and Immune System 0 0 0 0
Connective tissue diseases
Inflammatory and Immune System 0 0 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Ambrisentan
Treatment: Drugs - Placebo

Experimental: Ambrisentan -

Placebo Comparator: Placebo -


Treatment: Drugs: Ambrisentan
Ambrisentan (5mg or 10 mg tablet) was administered orally once daily.

Treatment: Drugs: Placebo
Placebo to match ambrisentan was administered orally once daily.

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
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
Timepoint [1] 0 0
Up to 48 months
Secondary outcome [1] 0 0
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.
Timepoint [1] 0 0
Baseline and Week 48
Secondary outcome [2] 0 0
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.
Timepoint [2] 0 0
Baseline and Week 48
Secondary outcome [3] 0 0
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.
Timepoint [3] 0 0
Baseline and Week 48
Secondary outcome [4] 0 0
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.
Timepoint [4] 0 0
Baseline and Week 48
Secondary outcome [5] 0 0
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.
Timepoint [5] 0 0
Baseline and Week 48
Secondary outcome [6] 0 0
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.
Timepoint [6] 0 0
Baseline and Week 48
Secondary outcome [7] 0 0
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.
Timepoint [7] 0 0
Baseline and Week 48
Secondary outcome [8] 0 0
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.
Timepoint [8] 0 0
Up to 48 weeks

Eligibility
Key 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
Minimum age
40 Years
Maximum age
80 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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 design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Terminated
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,SA,TAS,VIC,WA
Recruitment hospital [1] 0 0
- Concord
Recruitment hospital [2] 0 0
- Darlinghurst
Recruitment hospital [3] 0 0
- Chermside
Recruitment hospital [4] 0 0
- Woodville
Recruitment hospital [5] 0 0
- Hobart
Recruitment hospital [6] 0 0
- Parkville
Recruitment hospital [7] 0 0
- Prahran
Recruitment hospital [8] 0 0
- Perth
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
2010 - Darlinghurst
Recruitment postcode(s) [3] 0 0
4032 - Chermside
Recruitment postcode(s) [4] 0 0
5011 - Woodville
Recruitment postcode(s) [5] 0 0
7000 - Hobart
Recruitment postcode(s) [6] 0 0
3050 - Parkville
Recruitment postcode(s) [7] 0 0
3181 - Prahran
Recruitment postcode(s) [8] 0 0
6000 - Perth
Recruitment outside Australia
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Mancesheter

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/show/NCT00768300
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Ganesh Raghu, MD
Address 0 0
University of Washington, Div. of Pulmonary and Critical Care Medicine Chair
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT00768300