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

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:

Genetics Home Reference related topics: idiopathic pulmonary fibrosis

MedlinePlus related topics: High Blood Pressure Pulmonary Fibrosis Pulmonary Hypertension

Drug Information available for: Ambrisentan

U.S. FDA Resources

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 May 19, 2013