The efficacy & safety of Ambrisentan in Participants with Early IPF

• Research type

  Research Study

• Full title

  ARTEMIS-IPF: A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multi-Center, Parallel-Group, Event-Driven Study to Evaluate the Efficacy and Safety of Ambrisentan in Subjects with Early Idiopathic Pulmonary Fibrosis (IPF)

• IRAS ID

  7701

• Sponsor organisation

  Gilead Sciences Incorporated

• Eudract number

  2008-004405-34

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  Idiopathic pulmonary fibrosis (IPF) is a chronic, lung disease of unknown cause that's associated with the appearance of a type of pneumonia called usual interstitial pneumonia (UIP). It is a characterized by cough, exertional breathlessness and basilar cracklesIt is estimated that approximately 29,000 to 89,000 people in the US have been diagnosed with IPF. The course of the disease is usually slow, but ongoing. Most patients die of progressive respiratory failure within 3 to 8 years of the onset of symptoms.To date, there is no approved therapy for the treatment of IPF and Clinical trials have been highly variable.Ambrisentan is a drug being developed by Gilead. Ambrisentan (Letairis?½) is approved by the United States (U.S.) Food and Drug Administration (FDA) for the treatment of pulmonary arterial hypertension (PAH). The European Commission granted marketing authorization for ambrisentan under the trade name of Volibris© for the treatment of PAH on April 25, 2008Gilead believes that the drug ambrisentan, may be effective in the treatment of IPF This is a randomized, double-blind, placebo-controlled, multi-centre study to evaluate the efficacy and safety of ambrisentan in participants with IPF. The study consists of three periods: screening, titration and treatment. Study visits will occur every 84 days ( 6 days) from the first treatment visit. Eligible participants will be stratified based on (1) the presence or absence of pulmonary hypertension and (2) diagnosis UIP. Participants will be assigned randomly in a 2:1 ratio to receive either ambrisentan or placebo (an inactive 'dummy' treatment). During the titration period, participants will receive 5 mg ambrisentan or placebo once daily for 14 days. Participants will then receive 10 mg ambrisentan or placebo from the beginning of the treatment period through the remainder of the study. Treatment study visits will occur every 3 months until either the participants disease worsens, the study ends or the participant decides they do not want to participate any longer. In between clinic visits (every 28 days) participants will receive a phone call from the study team and a laboratory visit to check liver enzymes. This study is open to male or female participants, 40-80 years of age, with IPF. 600 participants will be enrolled from about 200 study sites worldwide. Participation in the study is expected to last between 1 to 3 years

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  09/H0408/28

• Date of REC Opinion

  8 Jun 2009

• REC opinion

  Further Information Favourable Opinion