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| ID | Type | Description | Link |
|---|---|---|---|
| ARIES-3 |
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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.
This study was to enroll up to 200 participants with 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). Participants with left heart disease or left heart failure were excluded (WHO Group 2). Participants could be receiving prostacyclin or sildenafil therapy at baseline, and participants who previously discontinued either bosentan, sitaxsentan, or both, due to liver function test abnormalities were eligible.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ambrisentan | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambrisentan | Drug | Oral tablets taken once daily. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 24 in 6 Minute Walk Distance (6MWD) | Baseline to Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline to Week 24 in Borg Dyspnea Index | 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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Summarized Inclusion Criteria:
Summarized Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lewis J Rubin, MD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Arizona Pulmonary Specialists, Ltd |
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| Label | URL |
|---|---|
| Related Info | View source |
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The screening period was 4 weeks. Participants who received bosentan or sitaxsentan within 4 weeks prior to the screening visit were excluded.
Enrollment occurred between September 2006 and January 2008 and the study was conducted between August 2006 and May 2009 in 39 centers in the United States, Australia and Canada
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| ID | Title | Description |
|---|---|---|
| FG000 | Ambrisentan | Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg). |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Baseline to Week 24 |
| Change From Baseline to Week 48 in Borg Dyspnea Index | 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. | Baseline to Week 48 |
| Percent Change From Baseline to Week 24 in B-type Natriuretic Peptide (BNP) | Baseline to Week 24 |
| Percent Change From Baseline to Week 48 in BNP | Baseline to Week 48 |
| Change From Baseline to Week 24 in WHO Functional Class | 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. | Baseline to Week 24 |
| Change From Baseline to Week 48 in WHO Functional Class | 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. | Baseline to Week 48 |
| Change From Baseline to Week 24 in SF-36 Health Survey Physical Functioning Scale | 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. | Baseline to Week 24 |
| Change From Baseline to Week 48 in SF-36 Health Survey Physical Functioning Scale | 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. | Baseline to Week 48 |
| Percent of Participants With no Clinical Worsening of Pulmonary Hypertension (PH) at Week 24 | 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 | Baseline to Week 24 |
| Percent of Participants With no Clinical Worsening of PH at Week 48 | 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 | Baseline to Week 48 |
| Failure-free Treatment Status | Defined by occurrence of death, lung transplantation, or study withdrawal due to the addition of other clinically approved PAH therapeutic agents | Baseline to Week 24 |
| Failure-free Treatment Status | Defined by occurrence of death, lung transplantation, or study withdrawal due to the addition of other clinically approved PAH therapeutic agents | Baseline to Week 48 |
| Monotherapy Treatment Status | Defined by no addition of sildenafil, iloprost, treprostinil, or epoprostenol to ongoing ambrisentan treatment | Baseline to Week 24 |
| Monotherapy Treatment Status | Defined by no addition of sildenafil, iloprost, treprostinil, or epoprostenol to ongoing ambrisentan treatment | Baseline to Week 48 |
| Long-term Survival | Defined as not dying during study participation | Baseline to Week 24 |
| Long-term Survival | Defined as not dying during study participation | Baseline to Week 48 |
| Phoenix |
| Arizona |
| 85013 |
| United States |
| UCSD Medical Center, Thornton Hospital | La Jolla | California | 92037 | United States |
| Greater Los Angeles, VA Medical Center | Los Angeles | California | 90073 | United States |
| Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center | Torrance | California | 90502 | United States |
| University of Colorado Health Sciences Center | Aurora | Colorado | 80045 | United States |
| University of Connecticut Health Center | Farmington | Connecticut | 06030 | United States |
| Pulmonary Hypertension Clinic Mount Sinai Medical Center | Miami Beach | Florida | 33140 | United States |
| Suncoast Lung Center | Sarasota | Florida | 34233 | United States |
| Medical College of Georgia | Augusta | Georgia | 30912 | United States |
| Atlanta Institute for Medical Research, Inc. | Decatur | Georgia | 30030 | United States |
| University of Chicago Hospitals | Chicago | Illinois | 60637 | United States |
| University of Iowa Hospitals and Clinics | Iowa City | Iowa | 52242 | United States |
| Johns Hopkins University | Baltimore | Maryland | 21287 | United States |
| Tufts-New England Medical Center | Boston | Massachusetts | 02111 | United States |
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| Boston Adult Congenital Heart Service | Boston | Massachusetts | 02115 | United States |
| Boston University School of Medicine | Boston | Massachusetts | 02118 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| University of Medicine & Dentistry of New Jersey | Newark | New Jersey | 07103 | United States |
| Newark Beth Israel Medical Center | Newark | New Jersey | 07112 | United States |
| New York Presbyterian Pulmonary Hypertension Center | New York | New York | 10032 | United States |
| Mary Parkes Asthma Center | Rochester | New York | 14623 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| The Lindner Clinical Trial Center | Cincinnati | Ohio | 45219 | United States |
| University Hospitals of Cleveland | Cleveland | Ohio | 44106 | United States |
| Legacy Clinical Northwest | Portland | Oregon | 97210 | United States |
| Allegheny General Hospital | Pittsburgh | Pennsylvania | 15212 | United States |
| University of Pittsburgh Medical Center Presbyterian | Pittsburgh | Pennsylvania | 15213 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Lexington Pulmonary and Critical Care | Lexington | South Carolina | 29072 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| University of Virginia Health Sciences Center | Charlottesville | Virginia | 22908 | United States |
| St. Vincent's Hospital | Darlinghurst | New South Wales | 2010 | Australia |
| Royal Perth Hospital | Perth | 6000 | Australia |
| Peter Lougheed Centre | Calgary | Alberta | T1Y 6J4 | Canada |
| University of Alberta Hospitals | Edmonton | Alberta | T6G 2B7 | Canada |
| Toronto General Hospital | Toronto | Ontario | M5G 2N2 | Canada |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Ambrisentan | Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg). |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline to Week 24 in 6 Minute Walk Distance (6MWD) | Full Analysis Set. Last Observation Carried forward. 4 participants were excluded from the analysis due to lack of post-baseline 6MWD data. | Posted | Jun 2009 | Mean | Standard Deviation | meters | Baseline to Week 24 |
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| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline to Week 24 in Borg Dyspnea Index | 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. | Full Analysis Set. Last Observation Carried forward. 4 participants were excluded from the analysis due to lack of post-baseline Borg Dyspnea Index data. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Week 24 |
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| Secondary | Change From Baseline to Week 48 in Borg Dyspnea Index | 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. | Full Analysis Set. Observed data. 114 participants were excluded from the analysis due to lack of Week 48 Borg Dyspnea Index data. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Week 48 |
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| Secondary | Percent Change From Baseline to Week 24 in B-type Natriuretic Peptide (BNP) | Full Analysis Set. Last Observation Carried forward. 10 participants were excluded from the analysis due to lack of baseline or post-baseline BNP data. | Posted | Geometric Mean | 95% Confidence Interval | Percent change in BNP | Baseline to Week 24 |
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| Secondary | Percent Change From Baseline to Week 48 in BNP | Full Analysis Set. Observed data. 111 participants were excluded from the analysis due to lack of baseline or Week 48 BNP data. | Posted | Geometric Mean | 95% Confidence Interval | Percent change in BNP | Baseline to Week 48 |
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| Secondary | Change From Baseline to Week 24 in WHO Functional Class | 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. | Full Analysis Set. Last Observation Carried Forward. 3 participants were not analyzed due to lack of post-baseline WHO functional class data. | Posted | Number | Percentage of participants | Baseline to Week 24 |
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| Secondary | Change From Baseline to Week 48 in WHO Functional Class | 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. | Full Analysis Set. Observed Data. 3 participants were not analyzed due to lack of post-baseline WHO functional class data. | Posted | Number | Percentage of participants | Baseline to Week 48 |
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| Secondary | Change From Baseline to Week 24 in SF-36 Health Survey Physical Functioning Scale | 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. | Full Analysis Set. Last Observation Carried forward. 26 participants were excluded from the analysis due to lack of baseline or post-baseline SF-36 data. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Week 24 |
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| Secondary | Change From Baseline to Week 48 in SF-36 Health Survey Physical Functioning Scale | 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. | Full Analysis Set. Last Observation Carried forward. 25 participants were excluded from the analysis due to lack of baseline or post-baseline SF-36 data. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Week 48 |
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| Secondary | Percent of Participants With no Clinical Worsening of Pulmonary Hypertension (PH) at Week 24 | 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 | Full analysis set. Participants who were lost to follow-up were censored at the date of last contact. | Posted | Number | Percentage of participants | Baseline to Week 24 |
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| Secondary | Percent of Participants With no Clinical Worsening of PH at Week 48 | 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 | Full analysis set. Participants who were lost to follow-up were censored at the date of last contact. | Posted | Number | Percentage of participants | Baseline to Week 48 |
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| Secondary | Failure-free Treatment Status | Defined by occurrence of death, lung transplantation, or study withdrawal due to the addition of other clinically approved PAH therapeutic agents | Full Analysis Set. Participants who were lost to follow-up were censored at the date of last contact. | Posted | Number | Percentage of participants | Baseline to Week 24 |
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| Secondary | Failure-free Treatment Status | Defined by occurrence of death, lung transplantation, or study withdrawal due to the addition of other clinically approved PAH therapeutic agents | Full Analysis Set. Participants who were lost to follow-up were censored at the date of last contact. | Posted | Number | Percentage of participants | Baseline to Week 48 |
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| Secondary | Monotherapy Treatment Status | Defined by no addition of sildenafil, iloprost, treprostinil, or epoprostenol to ongoing ambrisentan treatment | Full Analysis Set - Subset of participants who were not receiving other PH therapy at baseline. | Posted | Number | Percentage of participants | Baseline to Week 24 |
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| Secondary | Monotherapy Treatment Status | Defined by no addition of sildenafil, iloprost, treprostinil, or epoprostenol to ongoing ambrisentan treatment | Full Analysis Set - Subset of participants who were not receiving other PH therapy at baseline. | Posted | Number | Percentage of participants | Baseline to Week 48 |
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| Secondary | Long-term Survival | Defined as not dying during study participation | Full Analysis Set. Participants who were lost to follow-up were censored at the date of last contact. | Posted | Number | Percentage of participants | Baseline to Week 24 |
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| Secondary | Long-term Survival | Defined as not dying during study participation | Full Analysis Set. Participants who were lost to follow-up were censored at the date of last contact. | Posted | Number | Percentage of participants | Baseline to Week 48 |
|
|
AEs were to be collected during study and up to 72 hours after last dose. SAEs, including deaths, that occurred during the study or within 4 weeks of receiving the last dose of study drug, whether or not related to study drug, were to be reported.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ambrisentan | Eligible participants received 5 mg ambrisentan once daily for the first 24 weeks. One dose reduction to 2.5 mg was permitted during the 24-week fixed-dose treatment period if the participant did not tolerate the study drug. After the initial 24-week treatment period, investigators could adjust the study drug dose as clinically indicated (available doses were 2.5, 5, and 10 mg). | 97 | 224 | 203 | 224 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| alanine aminotransferase increased | Investigations | MedDRA (9.1) | Systematic Assessment |
| |
| aspartate aminotransferase increased | Investigations | MedDRA (9.1) | Systematic Assessment |
| |
| drug interaction | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| international normalised ratio increased | Investigations | MedDRA (9.1) | Systematic Assessment |
| |
| muscle tightness | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| narcotic intoxication | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| neutropenia | Blood and lymphatic system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| abdominal pain | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| abscess limb | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| atrial fibrillation | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| atrial flutter | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| atrioventricular block third degree | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| autoimmune hepatitis | Hepatobiliary disorders | MedDRA (9.1) | Systematic Assessment |
| |
| blood glucose increased | Investigations | MedDRA (9.1) | Systematic Assessment |
| |
| breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Systematic Assessment |
| |
| bronchiectasis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| bronchitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| bronchitis acute | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| cardiac failure congestive | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| cardio-respiratory arrest | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| cellulitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| central line infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| cerebrovascular accident | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| chest pain | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| deep vein thrombosis | Vascular disorders | MedDRA (9.1) | Systematic Assessment |
| |
| dehydration | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| device related infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| diabetes mellitus inadequate control | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| dizziness | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| drug hypersensitivity | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| endocarditis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| enteritis infectious | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| enterobacter infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| face oedema | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| femur fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| fluid overload | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| gastroenteritis viral | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| headache | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| hypervolaemia | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| hypoglycaemia | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| hypokalaemia | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| hyponatraemia | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| hypoventilation | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| influenza | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| left ventricular failure | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| liver function test abnormal | Investigations | MedDRA (9.1) | Systematic Assessment |
| |
| lower respiratory tract infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| lung neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Systematic Assessment |
| |
| mental status changes | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment |
| |
| migraine | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| migraine with aura | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| muscular weakness | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| non-cardiac chest pain | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| oedema | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| oedema peripheral | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| ovarian cyst ruptured | Reproductive system and breast disorders | MedDRA (9.1) | Systematic Assessment |
| |
| pericardial effusion | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| pleural effusion | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| pneumonia | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| pneumonia bacterial | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| productive cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| pulomonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| raynaud's phenomenon | Vascular disorders | MedDRA (9.1) | Systematic Assessment |
| |
| recurrent cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Systematic Assessment |
| |
| renal failure | Renal and urinary disorders | MedDRA (9.1) | Systematic Assessment |
| |
| renal failure acute | Renal and urinary disorders | MedDRA (9.1) | Systematic Assessment |
| |
| renal impairment | Renal and urinary disorders | MedDRA (9.1) | Systematic Assessment |
| |
| respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| respiratory tract infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| right ventricular failure | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| sedation | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Systematic Assessment |
| |
| sepsis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| shock haemorrhagic | Vascular disorders | MedDRA (9.1) | Systematic Assessment |
| |
| sickle cell anaemia with crisis | Congenital, familial and genetic disorders | MedDRA (9.1) | Systematic Assessment |
| |
| spinal compression fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| syncope | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| systemic lupus erythematosus | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| transaminase increased | Investigations | MedDRA (9.1) | Systematic Assessment |
| |
| transitional cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Systematic Assessment |
| |
| tremor | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (9.1) | Systematic Assessment |
| |
| urinary retention | Renal and urinary disorders | MedDRA (9.1) | Systematic Assessment |
| |
| urinary tract infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| vaginal haemorrhage | Reproductive system and breast disorders | MedDRA (9.1) | Systematic Assessment |
| |
| anaemia | Blood and lymphatic system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| iron deficiency anaemia | Blood and lymphatic system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| thrombocytopenia | Blood and lymphatic system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| cardiac arrest | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| cardiac failure | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| cor pulmonale | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| palpitations | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| supraventricular tachycardia | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| diverticular perforation | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| lower gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| peritonitis | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| appendicitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| arthritis infective | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| catheter sepsis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| gastroenteritis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| sepsis syndrome | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| septic shock | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| upper respiratory tract infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| accidental overdose | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| fall | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| fibula fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| thrombosis in device | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| tibia fracture | Injury, poisoning and procedural complications | MedDRA (9.1) | Systematic Assessment |
| |
| hepatic enzyme increased | Investigations | MedDRA (9.1) | Systematic Assessment |
| |
| diabetes mellitus | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| hyperkalaemia | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| fracture nonunion | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| scleroderma | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| presyncope | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| subarachnoid haemorrhage | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| pregnancy | Pregnancy, puerperium and perinatal conditions | MedDRA (9.1) | Systematic Assessment |
| |
| anxiety | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment |
| |
| confusional state | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment |
| |
| depression | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment |
| |
| nervousness | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment |
| |
| panic attack | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment |
| |
| suicidal ideation | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment |
| |
| suicide attempt | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment |
| |
| nephrolithiasis | Renal and urinary disorders | MedDRA (9.1) | Systematic Assessment |
| |
| renal failure chronic | Renal and urinary disorders | MedDRA (9.1) | Systematic Assessment |
| |
| acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| respiratory distress | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| skin ulcer | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| hypotension | Vascular disorders | MedDRA (9.1) | Systematic Assessment |
| |
| vasculitis | Vascular disorders | MedDRA (9.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| back pain | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| brain natriuretic peptide increased | Investigations | MedDRA (9.1) | Systematic Assessment |
| |
| cough | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| depression | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment |
| |
| diarrhoea | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| dizziness | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| fatigue | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| flushing | Vascular disorders | MedDRA (9.1) | Systematic Assessment |
| |
| headache | Nervous system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| hypokalemia | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| insomnia | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment |
| |
| nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| nausea | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| oedema peripheral | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| upper respiratory tract infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| urinary tract infection | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| vomiting | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| anaemia | Blood and lymphatic system disorders | MedDRA (9.1) | Systematic Assessment |
| |
| palpitations | Cardiac disorders | MedDRA (9.1) | Systematic Assessment |
| |
| abdominal pain | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| constipation | Gastrointestinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| chest pain | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| pyrexia | General disorders | MedDRA (9.1) | Systematic Assessment |
| |
| bronchitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| nasopharyngitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| sinusitis | Infections and infestations | MedDRA (9.1) | Systematic Assessment |
| |
| international normalised ratio increased | Investigations | MedDRA (9.1) | Systematic Assessment |
| |
| fluid overload | Metabolism and nutrition disorders | MedDRA (9.1) | Systematic Assessment |
| |
| anxiety | Psychiatric disorders | MedDRA (9.1) | Systematic Assessment |
| |
| epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (9.1) | Systematic Assessment |
| |
| rash | Skin and subcutaneous tissue disorders | MedDRA (9.1) | Systematic Assessment |
| |
| hypotension | Vascular disorders | MedDRA (9.1) | Systematic Assessment |
|
PIs have right disclose data upon publication of a multi-center publication coordinated by Sponsor or 18 months after Study is completed at all sites if multi-center publication is not submitted by Sponsor within 12 mos. PI to furnish Sponsor with copy of proposed disclosure at least 90 days prior to proposed disclosure. Sponsor has right to ensure accuracy of disclosure and request deletion of confidential information. Sponsor may not make editorial changes to the results or conclusions.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Martine Allard, PhD; Senior Clinical Research Scientist | Gilead Sciences Inc | 650-524-3898 | martine.allard@gilead.com |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C467894 | ambrisentan |
Not provided
Not provided
Not provided
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