Status:
TERMINATED
(ARTEMIS-IPF) Randomized, Placebo-Controlled Study to Evaluate Safety and Effectiveness of Ambrisentan in IPF
Lead Sponsor:
Gilead Sciences
Conditions:
Idiopathic Pulmonary Fibrosis
Eligibility:
All Genders
40-80 years
Phase:
PHASE3
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
494 Patients enrolled
Trial Details
Trial ID
NCT00768300
Start Date
December 1 2008
End Date
February 1 2011
Last Update
April 8 2014
Active Locations (185)
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1
University of Alabama at Birmingham Hospital
Birmingham, Alabama, United States, 35294
2
Pulmonary Associates
Phoenix, Arizona, United States, 85006
3
Scottsdale, Arizona, United States, 85258
4
David Geffen School of Medicine at UCLA(Harbor-UCLA Medical Center)
Los Angeles, California, United States, 90095