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

Descriptive Information
Brief Title † ARTEMIS-PH - Study of Ambrisentan in Subjects With Pulmonary Hypertension Associated With Idiopathic Pulmonary Fibrosis
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
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 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.
Detailed Description
Study Phase 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
Primary Outcome Measure † Change From Baseline in Six-minute Walk Distance (6MWD).
Secondary Outcome Measure † Long-term Survival
Condition † Idiopathic Pulmonary Fibrosis Pulmonary Hypertension
Intervention † DrugAmbrisentan
Study Arms / Comparison Groups Ambrisentan Participants were randomized to receive ambrisentan treatment at an initial dose of 5 mg for 4 weeks, followed by ambrisentan at the target dose of 10 mg for an additional 52 weeks Placebo Participants were randomized to receive placebo to match ambrisentan for 48 weeks, then transition to ambrisentan treatment at the initial dose of 5 mg for 4 weeks, followed by ambrisentan at the target dose of 10 mg for an additional 4 weeks.
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 40
Start Date † July 2009
Completion Date February 2011
Primary Completion Date February 2011
Eligibility Criteria † Selected 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. 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
Gender Both
Ages 35 Years - 80 Years
Accepts Healthy Volunteers No
Contacts ††
Location Countries † United States
Administrative Information
NCT ID † NCT00879229
Organization ID GS-US-300-0128
Secondary IDs ††
Responsible Party Sponsor
Study Sponsor † Gilead Sciences
Collaborators ††
Investigators † Study Director: Hunter Gillies, M.D., Gilead Sciences
Information Provided By
Verification Date May 2014
First Received Date † April 8, 2009
Last Updated Date May 5, 2014
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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