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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Idiopathic Pulmonary Fibrosis

In brief

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.

Key facts

Study ID

NCT00768300

Run by

Gilead Sciences

People needed

494

Starts

2008-12-01

Expected to finish

2011-02-01

Last updated by the study team

2014-04-08

Who can join

Age: 40 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Pulmonary Associates — Phoenix, Arizona, United States
• Study site — Scottsdale, Arizona, United States
• David Geffen School of Medicine at UCLA(Harbor-UCLA Medical Center) — Los Angeles, California, United States
• University of California, Davis — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Stanford University — Stanford, California, United States
• National Jewish Medical And Research Center — Denver, Colorado, United States
• Study site — Newark, Delaware, United States
• Bay Area Chest Physicians — Clearwater, Florida, United States
• University of Miami Miller School of Medicine — Miami, Florida, United States
• Study site — Tampa, Florida, United States
• Emory University — Atlanta, Georgia, United States
• University of Chicago — Chicago, Illinois, United States
• Study site — Council Bluffs, Iowa, United States
• Kentuckiana Pulmonary Association — Louisville, Kentucky, United States
• Study site — Louisville, Kentucky, United States
• Study site — Baltimore, Maryland, United States
• Study site — Baltimore, Maryland, United States
• Study site — Boston, Massachusetts, United States
• Study site — Boston, Massachusetts, United States
• Study site — Ann Arbor, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Saint Lukes Foundation — Chesterfield, Missouri, United States
• University of Alabama at Birmingham Hospital — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.