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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ambrisentan | Experimental | 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 | Placebo Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambrisentan | Drug | Ambrisentan (5 mg or 10 mg tablet) administered orally once daily. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Six-minute Walk Distance (6MWD). | The change from baseline in 6MWD at Week 16 (end of blinded treatment) was evaluated. | Baseline to Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Long-term Survival | Long-term survival was assessed as a Kaplan-Meier (KM) estimate of the percent probability of survival, with censoring at Week 48. | Week 48 |
| Transition Dyspnea Index (TDI) | 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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Selected Inclusion Criteria:
Selected Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hunter Gillies, M.D. | Gilead Sciences | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Mayo Clinic Arizona |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25613108 | Derived | 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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96 participants were screened; 40 participants were randomized and treated, and comprise the Safety Analysis Set and the Full Analysis Set.
Subjects were enrolled in a total of 29 study sites in Australia, Europe, and North America. The first participant was screened on 21 October 2009. The last participant observation was on 22 February 2011.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ambrisentan | Participants were randomized to receive ambrisentan treatment for 56 weeks |
| FG001 | Placebo | Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo | Drug | Placebo to match ambrisentan administered orally once daily. |
|
| Baseline to Week 16 |
| Change From Baseline in WHO Functional Class | 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. | Baseline to Week 16 |
| Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted | 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. | Baseline to Week 16 |
| Change From Baseline in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) | Assessment of the the level of the amino acid fragment NT-proBNP is used to establish prognosis in cardiovascular disease. | Baseline to Week 16 |
| Change From Baseline in the Borg Dyspnea Index (BORG) Immediately Following Exercise | 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). | Baseline to Week 16 |
| Hemoglobin-corrected Diffusing Capacity for Carbon Monoxide (DLCO) Percent Predicted | 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. | Baseline to Week 16 |
| Change in Quality of Life (QOL) Score as Assessed by the Short-Form 36® (SF-36) | 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. | Baseline to Week 16 |
| Change in QOL Score as Assessed by the St. George's Respiratory Questionnaire (SRGQ) | 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. | Baseline to Week 16 |
| Scottsdale |
| Arizona |
| 85259 |
| United States |
| University of California Davis | Davis | California | 95817 | United States |
| David Geffen School of Medicine UCLA | Los Angeles | California | 90095 | United States |
| University of California San Diego Medical Center | San Diego | California | 92103 | United States |
| University of California at San Francisco | San Francisco | California | 94143 | United States |
| Stanford University | Stanford | California | 94305 | United States |
| University of Colorado Heatlh Sciences Center | Aurora | Colorado | 80045 | United States |
| Bay Area Chest Physicians | Clearwater | Florida | 33756 | United States |
| University of Florida | Gainesville | Florida | 32610 | United States |
| University of Miami Medical Center | Miami | Florida | 33136 | United States |
| Suncoast Lung Center | Sarasota | Florida | 34233 | United States |
| Sarasota Memorial Hospital | Sarasota | Florida | 34239 | United States |
| Cleveland Clinic Florida | Weston | Florida | 33331 | United States |
| Atlanta Institute for Medical Research | Decatur | Georgia | 30030 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Kentuckiana Pulmonary Association | Louisville | Kentucky | United States |
| Maine Medical Center | Portland | Maine | United States |
| Johns Hopkins University School of Medicine | Baltimore | Maryland | 21205 | United States |
| Tufts Medical Center | Boston | Massachusetts | 02111 | United States |
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States |
| Boston University Medical Center | Boston | Massachusetts | 02118 | United States |
| Beth Israel Deacones Medical Center | Boston | Massachusetts | 02215 | United States |
| University of Michigan Health Systems | Ann Arbor | Michigan | 48109 | United States |
| Mayo Clinic Rochester | Rochester | Minnesota | 55905 | United States |
| Washington University | St Louis | Missouri | 63110 | United States |
| Creighton University Center for Allergy & Asthma | Omaha | Nebraska | 68131 | United States |
| Dartmouth Medical School | Lebanon | New Hampshire | 03756 | United States |
| Albany Medical Center | Albany | New York | 12208 | United States |
| Winthrop University Hospital | Mineola | New York | 11501 | United States |
| North Shore Health System | New Hyde Park | New York | 11040 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| Columbia University | New York | New York | 10032 | United States |
| University of North Carolina at Chapel Hill | Chapel Hill | North Carolina | 27599 | United States |
| Duke University Medical Center | Durham | North Carolina | 27710 | United States |
| The Lindner Center for Research & Education at The Christ Hospital | Cincinnati | Ohio | 45219 | United States |
| University Hospitals of Cleveland Case Western | Cleveland | Ohio | 44106 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | United States |
| Ohio State University | Columbus | Ohio | 43210 | United States |
| Hospital of the University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Temple University School of Medicine | Philadelphia | Pennsylvania | 19140 | United States |
| Alleghany General Hospital | Pittsburgh | Pennsylvania | 12512 | United States |
| University of Pittsburgh Cancer Institute | Pittsburgh | Pennsylvania | 15213 | United States |
| Medical University of South Carolina | Charleston | South Carolina | United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| University of Texas Southwestern | Dallas | Texas | 75390 | United States |
| Baylor College of Medicine | Houston | Texas | 77030 | United States |
| University of Utah | Salt Lake City | Utah | 84108 | United States |
| Inova Heart Institiute and Vascular Institute | Falls Church | Virginia | 22042 | United States |
| Virginia Commonwealth University Health System | Richmond | Virginia | 23298 | United States |
| Providence Everett Medical Center | Everett | Washington | 98201 | United States |
| St. Vincents Hospital | Sydney | New South Wales | 2010 | Australia |
| The Prince Charles Hospital | Chermside | Queensland | 4032 | Australia |
| Royal Perth Hospital | Perth | Western Australia | 6000 | Australia |
| Medizinische Universität Graz | Graz | 8036 | Austria |
| Universitatsklinikum Innsbruck | Innsbruck | Austria |
| Medizinische Universität Wien | Vienna | 1090 | Austria |
| Peter Loughheed Center- Calgary General Hospital | Calgary | Alberta | T1Y 6J4 | Canada |
| University of British Columbia | Vancouver | British Columbia | V5Z 1M9 | Canada |
| London Health Sciences Centre | London | Ontario | N6A 5W9 | Canada |
| Toronto General Hospital | Toronto | Ontario | Canada |
| Centre Hospitalier De L'Universite de Montreal | Montreal | Quebec | H2W 1T8 | Canada |
| Sir Mortimer B. Davis Jewish General Center | Montreal | Quebec | Canada |
| Centre de Pneumologie de L'Hospital Laval | Sainte-Foy | Quebec | G1V 4G5 | Canada |
| Evangelische Lungenklinik Berlin | Berlin | 13125 | Germany |
| Charite-Universitatsmedizin Berlin | Berlin | Germany |
| Krankenhaus Donaustauf der LVA | Donaustauf | 93093 | Germany |
| Universitatsklinikum Freiburg | Freiburg im Breisgau | 79095 | Germany |
| Universitat Greifswald | Greifswald | 17475 | Germany |
| Medizinische Hochschule Hannover | Hanover | 30625 | Germany |
| Thorax Klinik | Heidelberg | 66126 | Germany |
| LMU Klinikum der Universitat | München | Germany |
| Azienda Ospedaliero Universitaria | Catania | Italy |
| Presidio Ospedaliero G.B. Morgagni | Forlì | Italy |
| Ospedale S.Giuseppe Fatebenefratelli | Milan | Italy |
| Unita Funzionale di Pneumologia e Fisiopatologia Respiratoria | Milan | 20132 | Italy |
| Azienda Ospedaliera di Padova | Padova | Italy |
| Instituto Mediterraneo per i Trapianti e Terapie ad Alta Specializzazione | Palermo | Italy |
| Policlinico Universitario Tor Vergata | Rome | Italy |
| Azienda Ospedaliera Universitaria Senese | Siena | 53100 | Italy |
| Centro delle Interstiziopatie Polmonari e Malattie Rare del Polmone | Torino | 10043 | Italy |
| Papworth Hospital NHS Foundation Trust | Cambridge | CB23 3RE | United Kingdom |
| University Hospital Aintree | Liverpool | United Kingdom |
| University College Hosptial | London | United Kingdom |
| Royal Hallamshire Hospital | Sheffield | United Kingdom |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Full Analysis Set: participants who were randomized and received at least one dose of study drug
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| ID | Title | Description |
|---|---|---|
| BG000 | Ambrisentan | Participants were randomized to receive ambrisentan treatment for 56 weeks |
| BG001 | Placebo | Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| 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 |
| ||||||||||||||||
| Race/Ethnicity, Customized | Number | participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||
| Baseline Dyspnea Index (BDI) | BDI range is 0 to 12 (worst to best). | Mean | Standard Deviation | units on a scale |
|
| 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 in Six-minute Walk Distance (6MWD). | The change from baseline in 6MWD at Week 16 (end of blinded treatment) was evaluated. | Participants in the Full Analysis Set (randomized and received at least one dose of study medication) with evaluable data were analyzed. | Posted | Mean | Standard Error | meters | Baseline to Week 16 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Long-term Survival | Long-term survival was assessed as a Kaplan-Meier (KM) estimate of the percent probability of survival, with censoring at Week 48. | Full Analysis Set | Posted | Number | 95% Confidence Interval | percent probability (KM% estimate) | Week 48 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Transition Dyspnea Index (TDI) | 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). | Participants in the Full Analysis Set with evaluable data were analyzed. | Posted | Mean | Standard Deviation | units on a scale | Baseline to Week 16 |
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in WHO Functional Class | 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. | Participants in the Full Analysis Set with evaluable data were analyzed. | Posted | Number | units on a scale | Baseline to Week 16 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted | 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. | Insufficient data due to study termination | Posted | Baseline to Week 16 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in N-terminal Pro-B-type Natriuretic Peptide (NT-proBNP) | Assessment of the the level of the amino acid fragment NT-proBNP is used to establish prognosis in cardiovascular disease. | Insufficient data due to study termination | Posted | Baseline to Week 16 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change From Baseline in the Borg Dyspnea Index (BORG) Immediately Following Exercise | 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). | Insufficient data due to study termination | Posted | Baseline to Week 16 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Hemoglobin-corrected Diffusing Capacity for Carbon Monoxide (DLCO) Percent Predicted | 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. | Insufficient data due to study termination | Posted | Baseline to Week 16 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in Quality of Life (QOL) Score as Assessed by the Short-Form 36® (SF-36) | 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. | Insufficient data due to study termination | Posted | Baseline to Week 16 |
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Change in QOL Score as Assessed by the St. George's Respiratory Questionnaire (SRGQ) | 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. | Insufficient data due to study termination | Posted | Baseline to Week 16 |
|
|
Baseline to end of treatment
Adverse events were collected based on the randomization group and not with regards to the specific treatment received.
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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 | Participants were randomized to receive ambrisentan treatment for 56 weeks | 12 | 25 | 18 | 25 | ||
| EG001 | Placebo | Participants were randomized to receive placebo for 48 weeks, followed by ambrisentan treatment for 8 weeks. | 3 | 15 | 12 | 15 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Atrioventricular block complete | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Bradycardia | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Abdominal pain lower | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Procedural complication | Injury, poisoning and procedural complications | MedDRA (13.1) | Systematic Assessment |
| |
| Electrocardiogram T wave inversion | Investigations | MedDRA (13.1) | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Groin pain | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (13.1) | Systematic Assessment |
| |
| Renal failure | Renal and urinary disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Idiopathic pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Acute respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Interstitial lung disease | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Pulmonary fibrosis | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Respiratory failure | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Constipation | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Abdominal discomfort | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Myocardial infarction | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Hyperparathyroidism secondary | Endocrine disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Respiratory tract infection | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Lower respiratory tract infection | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA (13.1) | Systematic Assessment |
| |
| Joint sprain | Injury, poisoning and procedural complications | MedDRA (13.1) | Systematic Assessment |
| |
| Cardiac murmur | Investigations | MedDRA (13.1) | Systematic Assessment |
| |
| Eosinophil count increased | Investigations | MedDRA (13.1) | Systematic Assessment |
| |
| Decreased appetite | Metabolism and nutrition disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Hypercalcaemia | Metabolism and nutrition disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Proteinuria | Renal and urinary disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Orthopnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Ecchymosis | Skin and subcutaneous tissue disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Chest discomfort | General disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Chest pain | General disorders | MedDRA (13.1) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (13.1) | Systematic Assessment |
|
Study GS-US-300-0128 was terminated early with enrollment of 40 of 225 planned subjects.
After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trial Disclosures | Gilead Sciences, Inc. | ClinicalTrialDisclosures@gilead.com |
| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| 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
| Male |
|
| Asian |
|
| Australia |
|
| Italy |
|
| Canada |
|
| Germany |
|
|
|
|