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ARTEMIS-PH - Study of Ambrisentan in Subjects With Pulmonary Hypertension Associated With Idiopathic Pulmonary Fibrosis | Clinical Trials | Clareo Health

TERMINATEDPHASE3

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

NCT00879229•Gilead Sciences

View on ClinicalTrials.gov

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 fibrosis (IPF) and the poor prognosis for patients with IPF who are also diagnosed with PH, this study was designed to evaluate the effectiveness and safety of ambrisentan in that patient population.

Eligibility

Age

35 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

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 \< 40%
•Serum creatinine ≥ 2.5 mg/dL
•Required hemodialysis, peritoneal dialysis, or hemofiltration
•Female subject who was pregnant or breastfeeding
+5 more criteria

Locations (85)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Mayo Clinic Arizona

Scottsdale, Arizona, United States

University of California Davis

Davis, California, United States

David Geffen School of Medicine UCLA

Los Angeles, California, United States

University of California San Diego Medical Center

San Diego, California, United States

University of California at San Francisco

San Francisco, California, United States

Stanford University

Stanford, California, United States

University of Colorado Heatlh Sciences Center

Aurora, Colorado, United States

Bay Area Chest Physicians

Clearwater, Florida, United States

University of Florida

Gainesville, Florida, United States

Key Dates

Start Date

July 1, 2009

Primary Completion Date

February 1, 2011

Completion Date

February 1, 2011

Last Updated

May 15, 2014

Enrollment

ACTUAL participants

Conditions

Idiopathic Pulmonary FibrosisPulmonary Hypertension

Interventions

Ambrisentan

DRUG

Placebo

DRUG

A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast

NCT06238622

Idiopathic Pulmonary FibrosisProgressive Pulmonary Fibrosis

View study

RECRUITINGPHASE2

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

NCT07073820

Pulmonary Hypertension

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 15, 2014Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast

A Study to Learn About the Study Medicine (Called PF-07868489) in People With Pulmonary Arterial Hypertension Who Have Previously Participated in a Clinical Study With PF-07868489

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