ARTEMIS-PH - Study of Ambrisentan in Subjects With Pulmonary Hypertension Associated With Idiopathic Pulmonary Fibrosis

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

Summary

Ambrisentan is an endothelin receptor antagonist used for the treatment of pulmonary hypertension (PH). Based on research suggesting a role for endothelin-1 in the pathogenesis of idiopathic pulmonary fibrosis (IPF) and the poor prognosis for patients with IPF who are also diagnosed with PH, this study was designed to evaluate the effectiveness and safety of ambrisentan in that patient population.

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

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Ambrisentan; Endothelin Receptor Antagonists

Criteria

Selected Inclusion Criteria:

• Weight ≥ 40 kg at screening

• Diagnosis of IPF based on modified American Thoracic Society-European Respiratory Society guidelines

• Diagnosis of PH based on the following hemodynamic requirements: mean pulmonary artery pressure (mPAP ≥ 25 mm Hg; pulmonary vascular resistance > 240 dyne.sec/cm^5; pulmonary capillary wedge pressure or left ventricular end-diastolic pressure ≤ 15 mm Hg

• Forced vital capacity (FVC) ≥ 40%

• Able to walk at least 50 meters during two 6-minute walk tests

• If receiving calcium channel blockers, low-dose oral corticosteroids, immunosuppressive, cytoxic, or antifibrotic drugs dose must have been stable.

Selected Exclusion Criteria:

• Diagnosis of PH primarily due to an etiology other than IPF

• Surgical lung biopsy diagnosis other than Usual Interstitial Pneumonia

• Other known cause of interstitial lung disease

• Evidence of significant obstructive lung disease

• Recent hospitalization for an acute exacerbation of IPF

• Recent active pulmonary or upper respiratory tract infection

• Left ventricular ejection fraction < 40%

• Serum creatinine ≥ 2.5 mg/dL

• Required hemodialysis, peritoneal dialysis, or hemofiltration

• Female subject who was pregnant or breastfeeding

• Recent treatment for PH with an endothelin receptor antagonist (ERA), phosphodiesterase type 5 inhibitor, or prostacyclin derivative

• Recent treatment with high dose oral corticosteroids

• Recent treatment (within 4 weeks prior to screening) with imatinib mesylate (Gleevec)

• Alanine aminotransferase or aspartate aminotransferase lab value that was greater than 1.5 x the upper limit of the normal range

• Discontinued other ERA treatment for any adverse reaction other than those associated with liver function test abnormalities