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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT00380068
Registration number
NCT00380068
Ethics application status
Date submitted
21/09/2006
Date registered
25/09/2006
Date last updated
5/04/2012
Titles & IDs
Public title
Safety and Efficacy Study of Ambrisentan in Subjects With Pulmonary Hypertension
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Scientific title
ARIES-3: A Phase 3, Long-Term, Open-Label, Multicenter Safety and Efficacy Study of Ambrisentan in Subjects With Pulmonary Hypertension
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Secondary ID [1]
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ARIES-3
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Secondary ID [2]
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AMB-323
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
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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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Ambrisentan
Experimental: Ambrisentan -
Treatment: Drugs: Ambrisentan
Oral tablets taken 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 to Week 24 in 6 Minute Walk Distance (6MWD)
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Assessment method [1]
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Timepoint [1]
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Baseline to Week 24
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Secondary outcome [1]
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Change From Baseline to Week 24 in Borg Dyspnea Index
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Assessment method [1]
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Change from Baseline to Week 24 in Borg Dyspnea Index. The Borg Dyspnea Index of Perceived Exertion Scores range from 0 to 10. Best and Worst values are: 0 (Best) to 10 (Worst). Scales are described as rating of breathlessness and its description: 0= none; 0.5= very,very slight (just noticeable); 1= very slight; 2=slight; 3= moderate; 4= somewhat severe; 5= severe; 6 (in between severe and very severe); 7= very severe; 8 (in between very, very severe and maximum); 9= very, very severe; and 10= maximum.
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Timepoint [1]
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Baseline to Week 24
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Secondary outcome [2]
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Change From Baseline to Week 48 in Borg Dyspnea Index
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Assessment method [2]
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Change from Baseline to Week 48 in Borg Dyspnea Index. The Borg Dyspnea Index of Perceived Exertion Scores range from 0 to 10. Best and Worst values are: 0 (Best) to 10 (Worst). Scales are described as rating of breathlessness and its description: 0= none; 0.5= very,very slight (just noticeable); 1= very slight; 2=slight; 3= moderate; 4= somewhat severe; 5= severe; 6 (in between severe and very severe); 7= very severe; 8 (in between very, very severe and maximum); 9= very, very severe; and 10= maximum.
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Timepoint [2]
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Baseline to Week 48
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Secondary outcome [3]
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Percent Change From Baseline to Week 24 in B-type Natriuretic Peptide (BNP)
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Assessment method [3]
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Timepoint [3]
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Baseline to Week 24
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Secondary outcome [4]
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Percent Change From Baseline to Week 48 in BNP
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Assessment method [4]
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Timepoint [4]
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Baseline to Week 48
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Secondary outcome [5]
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Change From Baseline to Week 24 in WHO Functional Class
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Assessment method [5]
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Change from baseline in World Health Organization functional class (WHO) at Week 24 is the incidence of participants that improved, had no change, or worsened. WHO categories are 1 to 4 with the worse category at 4. Improvement = a category change from baseline of <= -1: change of -3 (eg, WHO from 4 to 1), change of -2 (eg, WHO from 3 to 1), change of -1 (eg, WHO from 2 to 1). Inversely, participants worsening are those with a category change from baseline of at least +1. No change in WHO functional class represents the percentage of participants with a change in category from baseline of 0.
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Timepoint [5]
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Baseline to Week 24
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Secondary outcome [6]
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Change From Baseline to Week 48 in WHO Functional Class
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Assessment method [6]
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Change from baseline in WHO at Week 48 is expressed as the incidence of participants that improved, had no change or worsened. WHO categories range from 1 to 4 with the worse category at 4. Improvement = a category change from baseline of <= -1: change of -3 (eg, WHO from 4 to 1), change of -2 (eg, WHO from 3 to 1), change of -1 (eg, WHO from 2 to 1). Inversely, participants worsening are those with a category change from baseline of at least +1. No change in WHO functional class represents the percentage of participants with a change in category from baseline of 0.
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Timepoint [6]
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Baseline to Week 48
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Secondary outcome [7]
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Change From Baseline to Week 24 in SF-36 Health Survey Physical Functioning Scale
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Assessment method [7]
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Change from baseline to Week 24 in the SF-36 health survey physical functioning scale. 10 activities rated by health limitations using 3 categories (1= Yes, limited a lot; 2= Yes, limited a little; and 3= No, not limited at all). The best score is 3 and the worst score is 1. Scores are transformed by subtracting the unit by the lowest raw score and dividing by the raw score range. The scores are then standardized with the 1998 General United States (US) population mean and standard deviation (SD). Finally, the scores are transformed to the norm-based scoring with a mean of 50 and SD of 10.
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Timepoint [7]
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Baseline to Week 24
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Secondary outcome [8]
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Change From Baseline to Week 48 in SF-36 Health Survey Physical Functioning Scale
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Assessment method [8]
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Change from baseline to Week 48 in the SF-36 health survey physical functioning scale. 10 activities are rated by health limitations using 3 categories (1= Yes, limited a lot; 2= Yes, limited a little; and 3= No, not limited at all). The best score is 3 and the worst score is 1. Scores are transformed by subtracting the unit by the lowest raw score and dividing by the raw score range. The scores are then standardized with the 1998 General US population mean and standard deviation. Finally, the scores are transformed to the norm-based scoring with a mean of 50 and standard deviation of 10.
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Timepoint [8]
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Baseline to Week 48
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Secondary outcome [9]
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Percent of Participants With no Clinical Worsening of Pulmonary Hypertension (PH) at Week 24
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Assessment method [9]
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Clinical worsening: occurrence of death, lung transplantation, hospitalization for PH, atrial septostomy, a change to chronic prostanoid or sildenafil treatment due to protocol-defined worsening criteria, or study withdrawal due to the addition of other clinically approved PH therapeutic agents
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Timepoint [9]
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Baseline to Week 24
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Secondary outcome [10]
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Percent of Participants With no Clinical Worsening of PH at Week 48
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Assessment method [10]
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Clinical worsening: occurrence of death, lung transplantation, hospitalization for PH, atrial septostomy, a change to chronic prostanoid or sildenafil treatment due to protocol-defined worsening criteria, or study withdrawal due to the addition of other clinically approved PH therapeutic agents
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Timepoint [10]
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Baseline to Week 48
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Secondary outcome [11]
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Failure-free Treatment Status
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Assessment method [11]
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Defined by occurrence of death, lung transplantation, or study withdrawal due to the addition of other clinically approved PAH therapeutic agents
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Timepoint [11]
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Baseline to Week 24
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Secondary outcome [12]
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Failure-free Treatment Status
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Assessment method [12]
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Defined by occurrence of death, lung transplantation, or study withdrawal due to the addition of other clinically approved PAH therapeutic agents
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Timepoint [12]
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Baseline to Week 48
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Secondary outcome [13]
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Monotherapy Treatment Status
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Assessment method [13]
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Defined by no addition of sildenafil, iloprost, treprostinil, or epoprostenol to ongoing ambrisentan treatment
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Timepoint [13]
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Baseline to Week 24
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Secondary outcome [14]
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Monotherapy Treatment Status
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Assessment method [14]
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Defined by no addition of sildenafil, iloprost, treprostinil, or epoprostenol to ongoing ambrisentan treatment
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Timepoint [14]
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Baseline to Week 48
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Secondary outcome [15]
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Long-term Survival
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Assessment method [15]
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Defined as not dying during study participation
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Timepoint [15]
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Baseline to Week 24
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Secondary outcome [16]
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Long-term Survival
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Assessment method [16]
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Defined as not dying during study participation
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Timepoint [16]
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Baseline to Week 48
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Eligibility
Key inclusion criteria
Summarized
1. 18 years of age or older
2. Current diagnosis of PH associated with an acceptable etiology as outlined in the
protocol, including: PH due to the following etiologies: 1) PAH including idiopathic
and familial PAH and PAH associated with collagen vascular disease, congenital
systemic-to-pulmonary shunts (including Eisenmenger's syndrome), human
immunodeficiency virus (HIV) infection, drugs and toxins, thyroid disorders, glycogen
storage disease, Gaucher disease, hemoglobinopathies, and splenectomy (WHO Group 1);
2) PH associated with lung diseases and/or hypoxemia, including chronic obstructive
pulmonary disease (COPD), interstitial lung disease (ILD), sleep-disordered breathing,
and alveolar hypoventilation disorders (WHO Group 3); 3) PH due to proximal or distal
chronic thromboembolic obstruction (WHO Group 4); and 4) PH due to sarcoidosis (WHO
Group 5).
3. Stable regimen (within four weeks) of chronic prostanoid, PDE-5 inhibitor, calcium
channel blocker, or 3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase
inhibitor therapy
4. Right heart catheterization completed prior to screening must meet pre-specified
criteria
5. Female participants of childbearing potential must have a negative serum pregnancy
test and must agree to use a reliable double method of contraception until study
completion and for at least four weeks following their final study visit.
6. Male participants must be informed of the potential risks of testicular tubular
atrophy and infertility associated with taking ambrisentan and queried regarding his
understanding of the potential risks as described in the Informed Consent Form.
Summarized
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Minimum age
18
Years
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Maximum age
No limit
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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
1. Participation in a previous clinical study with ambrisentan
2. Bosentan or sitaxsentan use within four weeks prior to the screening visit
3. Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) lab value that is
greater than 3 times the upper limit of normal at the screening visit
4. Pulmonary function tests not meeting the following pre-specified criteria: 1) mean
pulmonary arterial pressure (PAP) >= 25 mm Hg; 2) PVR > 3 mm Hg/L/min; 3) pulmonary
capillary wedge pressure (PCWP) or left ventricle end diastolic pressure (LVEDP) < 15
mm Hg; 4) total lung capacity (TLC) >= 70% of predicted normal for participants
without ILD or >= 60% of predicted normal in participants with ILD; forced expiratory
volume in 1 second (FEV1) >= 65% of predicted normal in participants without COPD or
>= 50% of predicted normal in participants with COPD
5. Contraindication to treatment with endothelin receptor antagonist (ERA)
6. History of malignancies other than basal cell carcinoma of the skin or in situ
carcinoma of the cervix within the past five years
7. Female participant who is pregnant or breastfeeding
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised 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
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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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
Completed
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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
1/08/2006
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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
1/05/2009
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Sample size
Target
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Accrual to date
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Final
224
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Recruitment in Australia
Recruitment state(s)
NSW
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Recruitment hospital [1]
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St. Vincent's Hospital - Darlinghurst
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Recruitment hospital [2]
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Royal Perth Hospital - Perth
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Recruitment postcode(s) [1]
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2010 - Darlinghurst
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Recruitment postcode(s) [2]
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6000 - Perth
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Alabama
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Country [2]
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United States of America
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State/province [2]
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Arizona
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Country [3]
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United States of America
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State/province [3]
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California
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Country [4]
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United States of America
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State/province [4]
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Colorado
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Country [5]
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United States of America
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State/province [5]
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Connecticut
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Country [6]
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United States of America
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State/province [6]
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Florida
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Country [7]
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United States of America
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State/province [7]
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Georgia
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Country [8]
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United States of America
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State/province [8]
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Illinois
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Country [9]
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United States of America
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State/province [9]
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Iowa
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Country [10]
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United States of America
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State/province [10]
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Maryland
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Country [11]
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United States of America
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State/province [11]
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Massachusetts
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Country [12]
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United States of America
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State/province [12]
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Minnesota
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Country [13]
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United States of America
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State/province [13]
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Missouri
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Country [14]
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United States of America
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State/province [14]
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New Jersey
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Country [15]
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United States of America
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State/province [15]
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New York
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Country [16]
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United States of America
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State/province [16]
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North Carolina
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Country [17]
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State/province [17]
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Ohio
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Country [18]
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State/province [18]
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Oregon
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Country [19]
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State/province [19]
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Pennsylvania
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Country [20]
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United States of America
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State/province [20]
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Rhode Island
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Country [21]
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United States of America
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State/province [21]
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South Carolina
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Country [22]
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State/province [22]
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Texas
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Country [23]
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United States of America
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State/province [23]
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Virginia
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Country [24]
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Canada
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State/province [24]
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Alberta
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Country [25]
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Canada
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State/province [25]
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Ontario
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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
The primary objective of this study was to evaluate the safety and efficacy of ambrisentan in
a broad population of participants with pulmonary hypertension (PH). Secondary objectives of
this study were to evaluate the effects of ambrisentan on other clinical measures of
pulmonary arterial hypertension (PAH), long-term treatment success, and survival.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00380068
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Lewis J Rubin, MD
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Address
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University of California, San Diego
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00380068
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