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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00879229
Registration number
NCT00879229
Ethics application status
Date submitted
8/04/2009
Date registered
9/04/2009
Date last updated
15/05/2014
Titles & IDs
Public title
ARTEMIS-PH - Study of Ambrisentan in Subjects With Pulmonary Hypertension Associated With Idiopathic Pulmonary Fibrosis
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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
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Secondary ID [1]
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GS-US-300-0128
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Universal Trial Number (UTN)
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Trial acronym
ARTEMIS-PH
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Idiopathic Pulmonary Fibrosis
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Pulmonary Hypertension
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Condition category
Condition code
Respiratory
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Other respiratory disorders / diseases
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Cardiovascular
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Hypertension
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Inflammatory and Immune System
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Connective tissue diseases
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ambrisentan
Treatment: Drugs - Placebo
Experimental: 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 comparator: 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.
Treatment: Drugs: Ambrisentan
Ambrisentan (5 mg or 10 mg tablet) administered orally once daily.
Treatment: Drugs: Placebo
Placebo to match ambrisentan administered orally once daily.
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Change From Baseline in Six-minute Walk Distance (6MWD).
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Assessment method [1]
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The change from baseline in 6MWD at Week 16 (end of blinded treatment) was evaluated.
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Timepoint [1]
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Baseline to Week 16
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Secondary outcome [1]
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Long-term Survival
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Assessment method [1]
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Long-term survival was assessed as a Kaplan-Meier (KM) estimate of the percent probability of survival, with censoring at Week 48.
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Timepoint [1]
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Week 48
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Secondary outcome [2]
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Transition Dyspnea Index (TDI)
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Assessment method [2]
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The change in TDI at Week 16 (end of blinded treatment) was evaluated. TDI measures the change from the baseline characteristic "Baseline Dyspnea Index." The TDI range is -9 to +9 (worst to best; 0 = no change).
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Timepoint [2]
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Baseline to Week 16
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Secondary outcome [3]
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Change From Baseline in WHO Functional Class
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Assessment method [3]
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WHO functional class rates severity of pulmonary hypertension, with 4 categories on a scale of 1 to 4 with the worst category being 4. Change is represented as an increase ("+1: Improved"), decrease ("-1: Deteriorated"), or no change ("0: No change") on the scale.
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Timepoint [3]
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Baseline to Week 16
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Secondary outcome [4]
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Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted
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Assessment method [4]
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FVC is a pulmonary function test, and is defined as the volume of air that can forcibly be blown out after taking a full breath. FVC% predicted is defined as FVC% of the patient divided by the average FVC% in the population for any person of similar age, sex and body composition.
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Timepoint [4]
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Baseline to Week 16
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Secondary outcome [5]
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Change From Baseline in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP)
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Assessment method [5]
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Assessment of the the level of the amino acid fragment NT-proBNP is used to establish prognosis in cardiovascular disease.
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Timepoint [5]
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Baseline to Week 16
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Secondary outcome [6]
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Change From Baseline in the Borg Dyspnea Index (BORG) Immediately Following Exercise
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Assessment method [6]
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Borg Dyspnea Index is a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness).
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Timepoint [6]
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Baseline to Week 16
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Secondary outcome [7]
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Hemoglobin-corrected Diffusing Capacity for Carbon Monoxide (DLCO) Percent Predicted
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Assessment method [7]
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DLCO is a pulmonary function test, and measures the partial pressure difference between inspired and expired carbon monoxide. DLCO% predicted is defined as DLCO% of the patient divided by the average DLCO% in the population for any person of similar age, sex and body composition.
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Timepoint [7]
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Baseline to Week 16
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Secondary outcome [8]
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Change in Quality of Life (QOL) Score as Assessed by the Short-Form 36® (SF-36)
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Assessment method [8]
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Each SF-36 score is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. An increase in score indicates an improvement in health state.
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Timepoint [8]
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Baseline to Week 16
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Secondary outcome [9]
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Change in QOL Score as Assessed by the St. George's Respiratory Questionnaire (SRGQ)
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Assessment method [9]
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The SRGQ is designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Patients respond to questions about symptoms (frequency \& severity) and impact components (social functioning and psychological disturbances resulting from airways disease). Scores range from 0 to 100, with higher scores indicating more limitations.
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Timepoint [9]
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Baseline to Week 16
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Eligibility
Key inclusion criteria
Selected
* 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.
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Minimum age
35
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Maximum age
80
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Stopped early
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/07/2009
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/02/2011
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Sample size
Target
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Accrual to date
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Final
40
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,WA
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Recruitment hospital [1]
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St. Vincents Hospital - Sydney
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Recruitment hospital [2]
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The Prince Charles Hospital - Chermside
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Recruitment hospital [3]
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
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2010 - Sydney
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Recruitment postcode(s) [2]
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4032 - Chermside
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Recruitment postcode(s) [3]
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6000 - Perth
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Recruitment outside Australia
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United States of America
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Alabama
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Arizona
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California
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Colorado
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Florida
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Georgia
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Illinois
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Kentucky
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Missouri
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Washington
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Austria
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Graz
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Austria
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Innsbruck
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Vienna
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Berlin
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Donaustauf
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Freiburg
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Greifswald
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Hannover
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Germany
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Heidelberg
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Germany
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Munchen
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Catania
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Italy
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Forli
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Italy
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Milano
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Italy
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Milan
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Italy
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Padova
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Italy
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Palermo
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Italy
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Rome
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Italy
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Siena
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Italy
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Torino
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United Kingdom
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Cambridge
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Liverpool
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London
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United Kingdom
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Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Gilead Sciences
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Address
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Country
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT00879229
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Trial related presentations / publications
Ruocco G, Cekorja B, Rottoli P, Refini RM, Pellegrini M, Di Tommaso C, Del Castillo G, Franci B, Nuti R, Palazzuoli A. Role of BNP and echo measurement for pulmonary hypertension recognition in patients with interstitial lung disease: An algorithm application model. Respir Med. 2015 Mar;109(3):406-15. doi: 10.1016/j.rmed.2014.12.011. Epub 2015 Jan 3.
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Public notes
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Contacts
Principal investigator
Name
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Hunter Gillies, M.D.
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Address
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Gilead Sciences
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Phone
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Fax
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Email
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Contact person for public queries
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00879229
Download to PDF