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

• Long-term survival [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
• Change from baseline in Borg Dyspnea Index [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]
• Change from baseline in WHO Functional Class [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]
• Change from baseline in pulmonary function tests (forced vital capacity [FVC] and diffusing capacity of the lung for carbon monoxide [DLCO]) [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]
• Change from baseline in baseline/transition dyspnea index (BDI/TDI) [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]
• Quality of Life assessments [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
• Change from baseline in N-terminal pro-B-type natriuretic peptide (NT-proBNP) [ Time Frame: Baseline to Week 16 ] [ Designated as safety issue: No ]

• Long-term survival [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
• Borg Dyspnea Index [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
• WHO Functional Class [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
• Pulmonary Function Tests (FVC and DLCO) [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
• BDI/TDI [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
• Quality of Life assessments [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
• NT-proBNP [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

This Phase 3, randomized, double-blind, placebo-controlled, multicenter study will compare the efficacy and safety of ambrisentan to placebo in subjects with pulmonary hypertension (PH) associated with idiopathic pulmonary fibrosis (IPF).

Please contact a Principle Investigator near you should you have any questions.

• Idiopathic Pulmonary Fibrosis
• Pulmonary Hypertension

• Drug: Ambrisentan
  Ambrisentan (5 mg or 10 mg tablet) administered orally once daily.
  Other Name: Letairis
• Drug: Placebo
  Placebo to match ambrisentan administered orally once daily.

• Experimental: Ambrisentan

  Initial dose: ambrisentan 5 mg, once daily for 4 weeks

  Target dose: ambrisentan 10 mg, once daily for 44 weeks

  Intervention: Drug: Ambrisentan
• Placebo Comparator: Placebo
  Placebo to match ambrisentan, once daily for 48 weeks
  Intervention: Drug: Placebo

Selected Inclusion Criteria:

• Diagnosis of IPF based on modified American Thoracic Society-European respiratory Society (ATS-ERS) guidelines
• Diagnosis of PH based on the following hemodynamic requirements: mean pulmonary artery pressure (mPAP_ ≥25 mmHg; pulmonary vascular resistance (PVR) >240 dyne.sec/cm5; pulmonary capillary wedge pressure (PCWP) or left ventricular end-diastolic pressure (LVEDP) ≤15 mmHg
• 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 be 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 (LVEF) <40%
• Serum creatinine ≥2.5 mg/dL
• Requires hemodialysis, peritoneal dialysis or hemofiltration
• Female subject who is pregnant or breastfeeding
• Recent treatment for PH with an ERA, phosphodiesterase type 5 (PDE-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 (ALT) or aspartate aminotransferase (AST) lab value that is greater than 1.5x the upper limit of the normal range (ULN)
• Discontinued other ERA treatment for any adverse reaction other than those associated with liver function test abnormalities