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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
Both
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.


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

Type of Study:

Interventional

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:

No

Principal Investigator

Hunter Gillies, M.D.

Investigator Role:

Study Director

Investigator Affiliation:

Gilead Sciences

Authority:

United States: Food and Drug Administration

Study ID:

GS-US-300-0128

NCT ID:

NCT00879229

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

Name

Location

Baylor College of MedicineHouston, Texas  77030
Cleveland Clinic FoundationCleveland, Ohio  44195
Medical University of South CarolinaCharleston, South Carolina  29425-0721
University of Washington Medical CenterSeattle, Washington  98195-6043
Mount Sinai School of MedicineNew York, New York  10029
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
Stanford UniversityStanford, California  94305
Maine Medical CenterPortland, Maine  04102
Sarasota Memorial HospitalSarasota, Florida  34239
Winthrop University HospitalMineola, New York  11501
Brigham and Women's HospitalBoston, Massachusetts  02115
Vanderbilt University Medical CenterNashville, Tennessee  37232-2516
University of VirginiaCharlottesville, Virginia  22908
Columbia UniversityNew York, New York  10032-3784
University of Alabama at BirminghamBirmingham, Alabama  35294-3300
University of UtahSalt Lake City, Utah  
Johns Hopkins University School of MedicineBaltimore, Maryland  21205
University of Michigan Health SystemsAnn Arbor, Michigan  48109
Duke University Medical CenterDurham, North Carolina  27710
University of FloridaGainesville, Florida  32610-0277
Hospital of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104
Ohio State UniversityColumbus, Ohio  43210
University of ChicagoChicago, Illinois  60637
Washington UniversitySt. Louis, Missouri  63110
Albany Medical CenterAlbany, New York  12208
Tufts Medical CenterBoston, Massachusetts  02111
University of California at San FranciscoSan Francisco, California  94115
Mayo Clinic RochesterRochester, Minnesota  55905
Providence Everett Medical CenterEverett, Washington  98201
University of North Carolina at Chapel HillChapel Hill, North Carolina  27599
Temple University School of MedicinePhiladelphia, Pennsylvania  19140
The Oregon ClinicPortland, Oregon  97213
Virginia Commonwealth University Health SystemRichmond, Virginia  23298
Boston University Medical CenterBoston, Massachusetts  02118
University of California DavisSacramento, California  95817
Cleveland Clinic FloridaWeston, Florida  33331
University of California San Diego Medical CenterSan Diego, California  92103-8409
Mayp Clinic ArizonaScottsdale, Arizona  85259
University of Texas SouthwesternDallas, California  75390
David Geffen School of medicine UCLALos Angeles, California  90095
Santa Barbara Pulmonary ConsultantsSanta Barbara, California  93105
University of colorado Heatlh Sciences CenterAurora, Colorado  80045
Bay Area Chest PhysiciansClearwater, Florida  33756
University of Miami Medical CenterMiami, Florida  331136
Suncoast Lung CenterSarasota, Florida  34233
Atlanta Institute for Medical ResearchDecatur, Georgia  30030
Pulmonary and Infectious Disease AssociatesCouncil Buffs, Iowa  
Kentuckiana Pulmonary AssociationLouisville, Kentucky  
Beth Israel Deacones Medical CenterBoston, Massachusetts  02215
Creighton University Center for Allergy & AsthmaOmaha, Nebraska  68131
Dartmouth Medical SchoolLebanon, New Hampshire  03756
Pulmonary Critical Care ServciesAlbany, New York  
North Shore Health SystemNew Hyde Park, New York  11040
The Lindner Center for Research & Education at The Christ HospitalCincinnati, Ohio  45219
University Hospitals of Cleveland Case WesternCleveland, Ohio  44106
Alleghany General HospitalPittsburgh, Pennsylvania  12512
Inova Heart Institiute and Vascular InstituteFalls Church, Virginia  22042