Conditions: Idiopathic Pulmonary Fibrosis
Keywords: idiopathic pulmonary fibrosis interstitial lung disease ambrisentan
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 494
Healthy volunteers: no

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.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Ambrisentan intervention 2: Placebo
Intervention descriptions: intervention 1: Ambrisentan (5mg or 10 mg tablet) was administered orally once daily. intervention 2: Placebo to match ambrisentan was administered orally once daily.

Protocol document: