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
  Purpose

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).


Condition Intervention Phase
Idiopathic Pulmonary Fibrosis
Pulmonary Hypertension
Drug: Ambrisentan
Drug: Placebo
Phase 3

Study Type: 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
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Change from baseline in six-minute walk distance (6MWD). [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 40
Study Start Date: July 2009
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ambrisentan

Initial dose: ambrisentan 5 mg, once daily for 4 weeks

Target dose: ambrisentan 10 mg, once daily for 44 weeks

Drug: Ambrisentan
Ambrisentan (5 mg or 10 mg tablet) administered orally once daily.
Other Name: Letairis
Placebo Comparator: Placebo
Placebo to match ambrisentan, once daily for 48 weeks
Drug: Placebo
Placebo to match ambrisentan administered orally once daily.

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   35 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00879229

  Show 95 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Hunter Gillies, M.D. Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT00879229     History of Changes
Other Study ID Numbers: GS-US-300-0128
Study First Received: April 8, 2009
Last Updated: January 7, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Idiopathic Pulmonary Fibrosis
Pulmonary Hypertension
PH
IPF
Ambrisentan
ERA
Endothelin Receptor Antagonist
Cardiovascular

Additional relevant MeSH terms:
Fibrosis
Hypertension
Hypertension, Pulmonary
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial

ClinicalTrials.gov processed this record on April 17, 2014