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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

Phase 3
35 Years
80 Years
Not Enrolling
Idiopathic Pulmonary Fibrosis, Pulmonary Hypertension

Thank you

Trial Information

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

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


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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Change from baseline in six-minute walk distance (6MWD).

Outcome Time Frame:

16 weeks

Safety Issue:


Principal Investigator

Hunter Gillies, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Gilead Sciences


United States: Food and Drug Administration

Study ID:




Start Date:

July 2009

Completion Date:

February 2011

Related Keywords:

  • Idiopathic Pulmonary Fibrosis
  • Pulmonary Hypertension
  • Idiopathic Pulmonary Fibrosis
  • Pulmonary Hypertension
  • PH
  • IPF
  • Ambrisentan
  • ERA
  • Endothelin Receptor Antagonist
  • Cardiovascular
  • Fibrosis
  • Hypertension
  • Hypertension, Pulmonary
  • Pulmonary Fibrosis
  • Idiopathic Pulmonary Fibrosis



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