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

• Register: ClinicalTrials.gov
• Last refreshed on: 19 October 2017
• Main ID: NCT00879229
• Date of registration: 08/04/2009
• Prospective Registration: Yes
• Primary sponsor: Gilead Sciences
• Public title: ARTEMIS-PH - Study of Ambrisentan in Subjects With Pulmonary Hypertension Associated With Idiopathic Pulmonary Fibrosis ARTEMIS-PH
• Scientific 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
• Date of first enrolment: July 2009
• Target sample size: 40
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT00879229
• Study type: Interventional
• Phase: Phase 3

Countries of recruitment

Australia, Austria, Belgium, Canada, Germany, Ireland, Israel, Italy, United Kingdom, United States

Contacts

• Name: Hunter Gillies, M.D.
• Affiliation: Gilead Sciences

Key inclusion & exclusion 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 < 40%

- Serum creatinine = 2.5 mg/dL

- Required hemodialysis, peritoneal dialysis, or hemofiltration

- Female subject who was pregnant or breastfeeding

- Recent treatment for PH with an endothelin receptor antagonist (ERA),
phosphodiesterase type 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 or aspartate aminotransferase lab value that was greater than
1.5 x the upper limit of the normal range

- Discontinued other ERA treatment for any adverse reaction other than those associated
with liver function test abnormalities



Age minimum: 35 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Hypertension

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: Ambrisentan

Drug: Placebo

Primary Outcome(s)

Change From Baseline in Six-minute Walk Distance (6MWD). [Time Frame: Baseline to Week 16]

Secondary Outcome(s)

Change in QOL Score as Assessed by the St. George's Respiratory Questionnaire (SRGQ) [Time Frame: Baseline to Week 16]

Hemoglobin-corrected Diffusing Capacity for Carbon Monoxide (DLCO) Percent Predicted [Time Frame: Baseline to Week 16]

Change From Baseline in the Borg Dyspnea Index (BORG) Immediately Following Exercise [Time Frame: Baseline to Week 16]

Change From Baseline in WHO Functional Class [Time Frame: Baseline to Week 16]

Change in Quality of Life (QOL) Score as Assessed by the Short-Form 36® (SF-36) [Time Frame: Baseline to Week 16]

Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted [Time Frame: Baseline to Week 16]

Change From Baseline in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) [Time Frame: Baseline to Week 16]

Long-term Survival [Time Frame: Week 48]

Transition Dyspnea Index (TDI) [Time Frame: Baseline to Week 16]

Secondary ID(s)

GS-US-300-0128

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 22/04/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00879229