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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT00879229
First received: April 8, 2009
Last updated: January 7, 2013
Last verified: January 2013

April 8, 2009
January 7, 2013
July 2009
February 2011   (final data collection date for primary outcome measure)
Change from baseline in six-minute walk distance (6MWD). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00879229 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
 
ARTEMIS-PH - Study of Ambrisentan in Subjects With Pulmonary Hypertension Associated With Idiopathic Pulmonary Fibrosis
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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
40
February 2011
February 2011   (final data collection date for primary outcome measure)

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
Both
35 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Australia,   Austria,   Belgium,   Canada,   Germany,   Ireland,   Israel,   Italy,   United Kingdom
 
NCT00879229
GS-US-300-0128
Yes
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Hunter Gillies, M.D. Gilead Sciences
Gilead Sciences
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP