ARTEMIS-PH - Study of Ambrisentan in Subjects With Pulmonary Hypertension Associated With Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis; Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Hypertension; Fibrosis
Intervention: Ambrisentan; Placebo
Intervention description: Ambrisentan (5 mg or 10 mg tablet) administered orally once daily.; Placebo to match ambrisentan administered orally once daily.
Intervention MeSH terms: Ambrisentan
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 40.0
Sex: All
Minimum age: 35 Years
Maximum age: 80 Years
Healthy volunteers: No
Keywords: Idiopathic Pulmonary Fibrosis; Pulmonary Hypertension; PH; IPF; Ambrisentan; ERA; Endothelin Receptor Antagonist; Cardiovascular

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.
    

Eligibility 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