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

• Status: Terminated
• Trial end date: 2011-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Ambrisentan

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