The efficacy & safety of Ambrisentan in Participants with IPF & PH
Research type
Research Study
Full title
ARTEMIS-PH: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Idiopathic Pulmonary Fibrosis and Pulmonary Hypertension
IRAS ID
27176
Sponsor organisation
Gilead Sciences Incorporated
Eudract number
2009-011169-98
Clinicaltrials.gov Identifier
Research summary
Idiopathic pulmonary fibrosis (IPF) is a chronic, lung disease of unknown cause that is associated with the appearance of a type of pneumonia called usual interstitial pneumonia (UIP). It is a characterized by cough, exertional breathlessness and basilar crackles. IPF is rare. Less than 3 in 10,000 people develop this disease. However, it is getting more common. The course of the disease is usually slow, but most patients die of progressive respiratory failure within 3 to 8 years of the onset of symptoms. Pulmonary hypertension (PH) is a rare blood vessel disorder of the lung. Pressure in the pulmonary artery (the blood vessel from the heart to the lungs) rises above normal levels and may become life threatening. IPF patients who also have PH have a worse prognosis; some reports have shown 5-fold increased risk of mortality compared to IPF subjects without PH. Ambrisentan is a drug being developed by Gilead. Ambrisentan is an approved treatment for pulmonary arterial hypertension in America and Europe. Gilead believes that ambrisentan, may be effective in the treatment of PH associated with IPF. This is a clinical study to test the effectiveness and safety of ambrisentan in people with IPF and PH. Eligible participants will be assigned randomly to receive either ambrisentan or placebo (an inactive 'dummy' treatment). Neither the participant nor the doctor will know which treatment has been assigned, but the doctor can find out in an emergency. Following a 4 week screening period, treatment will continue for 56 weeks. Participants who were receiving placebo will be switched to ambrisentan for the last 8 weeks of treatment. Clinic visits and/or safety evaluations occur monthly throughout the treatment period. This study will recruit males and females, 40-80 years old, with PH-IPF. 225 participants will be enrolled from about 80 study sites worldwide.
REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
09/H0408/90
Date of REC Opinion
30 Oct 2009
REC opinion
Further Information Favourable Opinion