Status:
TERMINATED
ARTEMIS-PH - Study of Ambrisentan in Subjects With Pulmonary Hypertension Associated With Idiopathic Pulmonary Fibrosis
Lead Sponsor:
Gilead Sciences
Conditions:
Idiopathic Pulmonary Fibrosis
Pulmonary Hypertension
Eligibility:
All Genders
35-80 years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- Selected
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00879229
Start Date
July 1 2009
End Date
February 1 2011
Last Update
May 15 2014
Active Locations (85)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
2
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
3
University of California Davis
Davis, California, United States, 95817
4
David Geffen School of Medicine UCLA
Los Angeles, California, United States, 90095