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

Gilead Sciences

Status and phase

Terminated

Phase 3

Conditions

Idiopathic Pulmonary Fibrosis

Treatments

Drug: Placebo

Drug: Ambrisentan

Study type

Interventional

Funder types

Industry

Identifiers

NCT00768300

GS-US-231-0101

Details and patient eligibility

About

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.

Enrollment

494 patients

Sex

All

Ages

40 to 80 years old

Volunteers

No Healthy Volunteers

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