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This Phase 2 study was to determine the incidence of increased serum aminotransferase concentrations (alanine aminotransferase [ALT] and/or aspartate aminotransferase [AST]), as well as the overall safety and tolerability of ambrisentan, in participants with pulmonary arterial hypertension (PAH), idiopathic PAH (IPAH), or familial PAH (FPAH) who had previously discontinued ERA therapy (bosentan or sitaxsentan) due to increased serum ALT or AST concentrations.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ambrisentan | Drug | All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg). |
| Measure | Description | Time Frame |
|---|---|---|
| The Incidence of Confirmed Serum Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Concentrations > 3 x the Upper Limit of Normal (ULN) Considered to be Related to Ambrisentan and Resulted in Discontinuation of Study Drug. | The number of participants in the safety analysis set with confirmed serum ALT or AST concentrations > 3 x ULN during 12 weeks of ambrisentan therapy that were related to ambrisentan and resulted in discontinuation of study drug. Safety analysis set included all participants who received at least 1 dose of study drug. | Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| The Incidence of Confirmed Serum ALT or AST Concentrations > 5 x ULN That Were Related to Ambrisentan and Resulted in Discontinuation of Study Drug. | The number of participants in the safety analysis set with confirmed serum ALT or AST concentrations > 5 x ULN during 12 weeks of ambrisentan therapy that were related to ambrisentan and resulted in discontinuation of drug. Safety analysis set included all participants who received at least 1 dose of study drug. |
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Summary of Inclusion Criteria:
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18812445 | Derived | McGoon MD, Frost AE, Oudiz RJ, Badesch DB, Galie N, Olschewski H, McLaughlin VV, Gerber MJ, Dufton C, Despain DJ, Rubin LJ. Ambrisentan therapy in patients with pulmonary arterial hypertension who discontinued bosentan or sitaxsentan due to liver function test abnormalities. Chest. 2009 Jan;135(1):122-129. doi: 10.1378/chest.08-1028. Epub 2008 Sep 23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ambrisentan | All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Ambrisentan | All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | The Incidence of Confirmed Serum Alanine Aminotransferase (ALT) or Aspartate Aminotransferase (AST) Concentrations > 3 x the Upper Limit of Normal (ULN) Considered to be Related to Ambrisentan and Resulted in Discontinuation of Study Drug. | The number of participants in the safety analysis set with confirmed serum ALT or AST concentrations > 3 x ULN during 12 weeks of ambrisentan therapy that were related to ambrisentan and resulted in discontinuation of study drug. Safety analysis set included all participants who received at least 1 dose of study drug. | The Safety analysis set was defined as all subjects who received at least 1 dose of study drug. All subjects who received at least 1 dose of ambrisentan were followed (to the extent possible) to the end of the study and included in the analyses of safety. | Posted | Number | Participants | Week 12 |
|
Baseline to Week 189
Median exposure to study drug was 108.1 weeks (2.08 years). Two subjects discontinued ambrisentan because of adverse events after 1 and 3 weeks, respectively. Reporting interval for all other subjects was from 36 to 189 weeks.
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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 | All eligible subjects received 2.5 mg ambrisentan once daily for a period of 4 weeks before increasing the dose to 5 mg once daily. After Week 24, investigators were allowed to adjust the dose of ambrisentan as clinically indicated (available doses were 2.5, 5, and 10 mg). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anaemia | Blood and lymphatic system disorders | MedDRA 8.0 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| anaemia | Blood and lymphatic system disorders | MedDRA (8.0) | Systematic Assessment |
Seven subjects were excluded from the change from baseline analysis of the SF-36 Health Survey because the incorrect version of the SF-36 questionnaire was used for evaluation at baseline, which made comparisons problematic.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Annemarie Vance | Gilead Sciences, Inc. | 650-524-3829 | Annemarie.Vance@gilead.com |
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| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006973 | Hypertension |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C467894 | ambrisentan |
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| Week 12 |
| The Incidence of Confirmed Serum ALT or AST Concentrations > 3 x ULN That Were Related to Ambrisentan and Resulted in Dose Reduction | The number of participants in the safety analysis set with confirmed serum ALT or AST concentrations > 3 x ULN during 12 weeks of ambrisentan therapy that were related to ambrisentan and resulted in dose reduction. Safety analysis set included all participants who received at least 1 dose of study drug. | Week 12 |
| A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in the 6-Minute Walk Distance Test (6MWD) | The 6MWD test is a measure of exercise tolerance, and measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. | Baseline to Week 12 |
| A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in Borg Dyspnea Index Immediately Following Exercise | Change from baseline evaluated after 12 weeks of ambrisentan therapy in Borg dyspnea index (measured as units on a scale) immediately following exercise. Borg Dyspnea Index, a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness). | Baseline to Week 12 |
| A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in WHO Functional Class | Classes: I) pulmonary hypertension (PH); ordinary physical activity not limited or causes undue dyspnea or fatigue, chest pain, or near syncope. II) PH; ordinary physical activity slightly limited and causes undue dyspnea or fatigue, chest pain, or near syncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes undue dyspnea or fatigue, chest pain, or near syncope; comfortable at rest. IV) PH; physical activity causes symptoms and increased discomfort; signs of right heart failure; dyspnea/fatigue possibly at rest. | Baseline to Week 12 |
| A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in Short Form 36 (SF-36) Health Survey Scale - Composite Physical Health | The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The first 6 concepts constitute the physical component summary. Each item is scored from 0 to 100 (least healthy to most healthy). | Baseline to Week 12 |
| Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Composite Mental Health | The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The last 5 concepts constitute the mental component summary. Each item is scored from 0 to 100 (least healthy to most healthy). | Baseline to Week 12 |
| Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Physical Functioning | The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy). | Baseline to Week 12 |
| Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Role Physical | The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy). | Baseline to Week 12 |
| Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Bodily Pain | The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy). | Baseline to Week 12 |
| Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - General Health | The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy). | Baseline to Week 12 |
| Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Vitality | The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy). | Baseline to Week 12 |
| Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Social Functioning | The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy). | Baseline to Week 12 |
| Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Role Emotional | The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy). | Baseline to Week 12 |
| Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Mental Health | The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy). | Baseline to Week 12 |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Region of Enrollment | Number | participants |
|
| Pulmonary Arterial Hypertension Etiology | Number | participants |
|
| Pulmonary Arterial Hypertension Treatment | Ambrisentan treatment was started on study Day 1. Concomitant sildenafil and prostanoids had to be stable for 4 weeks before screening. | Number | participants |
|
| World Health Organization (WHO) Functional Class | Classes: I) pulmonary hypertension (PH); ordinary physical activity not limited or causes undue dyspnea or fatigue, chest pain, or near syncope. II) PH; ordinary physical activity slightly limited and causes undue dyspnea or fatigue, chest pain, or near syncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes undue dyspnea or fatigue, chest pain, or near syncope; comfortable at rest. IV) PH; physical activity causes symptoms and increased discomfort; signs of right heart failure; dyspnea/fatigue possibly at rest. | Number | participants |
|
| Baseline 6-Minute Walk Distance | Mean | Standard Deviation | meters |
|
| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
|
| Borg dyspnea index | Borg Dyspnea Index, a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness). | Mean | Standard Deviation | units on a scale |
|
| Cardiac index | Historical values from most recent catheterization. | Mean | Standard Deviation | L/min/m^2 |
|
| Height | Mean | Standard Deviation | cm |
|
| Mean pulmonary artery pressure | Historical values from most recent catheterization. | Mean | Standard Deviation | mmHg |
|
| Pulmonary arterial hypertension present | Duration (in years) of pulmonary arterial hypertension at baseline. | Mean | Standard Deviation | year |
|
| Pulmonary capillary wedge pressure | Historical values from most recent catheterization. | Mean | Standard Deviation | mmHg |
|
| Pulmonary vascular resistance | Historical values from most recent catheterization. | Mean | Standard Deviation | mmHg/L/min |
|
| Right atrial pressure | Historical values from most recent catheterization. | Mean | Standard Deviation | mmHg |
|
| Weight | Mean | Standard Deviation | kg |
|
|
|
|
| Secondary | The Incidence of Confirmed Serum ALT or AST Concentrations > 5 x ULN That Were Related to Ambrisentan and Resulted in Discontinuation of Study Drug. | The number of participants in the safety analysis set with confirmed serum ALT or AST concentrations > 5 x ULN during 12 weeks of ambrisentan therapy that were related to ambrisentan and resulted in discontinuation of drug. Safety analysis set included all participants who received at least 1 dose of study drug. | The Safety analysis set was defined as all subjects who received at least 1 dose of study drug. All subjects who received at least 1 dose of ambrisentan were followed (to the extent possible) to the end of the study and included in the analyses of safety. | Posted | Number | participants | Week 12 |
|
|
|
| Secondary | The Incidence of Confirmed Serum ALT or AST Concentrations > 3 x ULN That Were Related to Ambrisentan and Resulted in Dose Reduction | The number of participants in the safety analysis set with confirmed serum ALT or AST concentrations > 3 x ULN during 12 weeks of ambrisentan therapy that were related to ambrisentan and resulted in dose reduction. Safety analysis set included all participants who received at least 1 dose of study drug. | The Safety analysis set was defined as all subjects who received at least 1 dose of study drug. All subjects who received at least 1 dose of ambrisentan were followed (to the extent possible) to the end of the study and included in the analyses of safety. | Posted | Number | participants | Week 12 |
|
|
|
| Secondary | A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in the 6-Minute Walk Distance Test (6MWD) | The 6MWD test is a measure of exercise tolerance, and measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. | The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value. | Posted | Mean | Standard Deviation | meters | Baseline to Week 12 |
|
|
|
|
| Secondary | A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in Borg Dyspnea Index Immediately Following Exercise | Change from baseline evaluated after 12 weeks of ambrisentan therapy in Borg dyspnea index (measured as units on a scale) immediately following exercise. Borg Dyspnea Index, a measure of perceived shortness of breath: 0 units on a scale (none) to 10 units on a scale (maximum breathlessness). | The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Week 12 |
|
|
|
|
| Secondary | A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in WHO Functional Class | Classes: I) pulmonary hypertension (PH); ordinary physical activity not limited or causes undue dyspnea or fatigue, chest pain, or near syncope. II) PH; ordinary physical activity slightly limited and causes undue dyspnea or fatigue, chest pain, or near syncope; comfortable at rest. III) PH; physical activity markedly limited and less than ordinary physical activity causes undue dyspnea or fatigue, chest pain, or near syncope; comfortable at rest. IV) PH; physical activity causes symptoms and increased discomfort; signs of right heart failure; dyspnea/fatigue possibly at rest. | The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value. | Posted | Number | Participants | Baseline to Week 12 |
|
|
|
| Secondary | A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in Short Form 36 (SF-36) Health Survey Scale - Composite Physical Health | The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The first 6 concepts constitute the physical component summary. Each item is scored from 0 to 100 (least healthy to most healthy). | The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Week 12 |
|
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|
|
| Secondary | Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Composite Mental Health | The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). The last 5 concepts constitute the mental component summary. Each item is scored from 0 to 100 (least healthy to most healthy). | The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Week 12 |
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| Secondary | Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Physical Functioning | The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy). | The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Week 12 |
|
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| Secondary | Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Role Physical | The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy). | The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Week 12 |
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| Secondary | Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Bodily Pain | The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy). | The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Week 12 |
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| Secondary | Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - General Health | The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy). | The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Week 12 |
|
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| Secondary | Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Vitality | The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy). | The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Week 12 |
|
|
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| Secondary | Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Social Functioning | The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy). | The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Week 12 |
|
|
|
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| Secondary | Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Role Emotional | The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy). | The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Week 12 |
|
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|
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| Secondary | Secondary Outcome: A Change From Baseline Evaluated After 12 Weeks of Ambrisentan Therapy in SF-36 Health Survey Scale - Mental Health | The SF-36 Health Survey is a self-reporting, multi-item scale measuring 8 health concepts: 1) physical functioning, 2) role limitations due to physical health problems, 3) bodily pain, 4) general health, 5) vitality (energy/fatigue), 6) social functioning, 7) role limitations due to emotional problems and 8) mental health (psychological distress and psychological well-being). Each item is scored from 0 to 100 (least healthy to most healthy). | The Intention-to-Treat (ITT) analysis set was defined as all subjects who received at least 1 dose of study drug and had at least 1 postdose efficacy value. | Posted | Mean | Standard Deviation | Units on a scale | Baseline to Week 12 |
|
|
|
|
| 17 |
| 36 |
| 36 |
| 36 |
| microcytic anaemia | Blood and lymphatic system disorders | MedDRA (8.0) | Systematic Assessment |
|
| acute coronary syndrome | Cardiac disorders | MedDRA (8.0) | Systematic Assessment |
|
| acute myocardial infarction | Cardiac disorders | MedDRA (8.0) | Systematic Assessment |
|
| atrial fibrillation | Cardiac disorders | MedDRA (8.0) | Systematic Assessment |
|
| atrial tachycardia | Cardiac disorders | MedDRA (8.0) | Systematic Assessment |
|
| cardiac arrest | Cardiac disorders | MedDRA (8.0) | Systematic Assessment |
|
| coronary artery disease | Cardiac disorders | MedDRA (8.0) | Systematic Assessment |
|
| palpitations | Cardiac disorders | MedDRA (8.0) | Systematic Assessment |
|
| right ventricular failure | Cardiac disorders | MedDRA (8.0) | Systematic Assessment |
|
| supraventricular tachycardia | Cardiac disorders | MedDRA (8.0) | Systematic Assessment |
|
| gastrointestinal arteriovenous malformation | Congenital, familial and genetic disorders | MedDRA (8.0) | Systematic Assessment |
|
| diarrhoea | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| chest pain | General disorders | MedDRA (8.0) | Systematic Assessment |
|
| infusion site pain | General disorders | MedDRA (8.0) | Systematic Assessment |
|
| catheter site cellulitis | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
|
| central line infection | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
|
| gastroenteritis | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
|
| gastroenteritis viral | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
|
| lobar pneumonia | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
|
| pneumococcal sepsis | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
|
| pneumonia | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
|
| staphylococcal bacteraemia | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
|
| upper respiratory tract infection | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
|
| blood potassium increased | Investigations | MedDRA (8.0) | Systematic Assessment |
|
| dehydration | Metabolism and nutrition disorders | MedDRA (8.0) | Systematic Assessment |
|
| hypokalaemia | Metabolism and nutrition disorders | MedDRA (8.0) | Systematic Assessment |
|
| hyponatraemia | Metabolism and nutrition disorders | MedDRA (8.0) | Systematic Assessment |
|
| breast cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (8.0) | Systematic Assessment |
|
| dizziness | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
|
| dizziness postural | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
|
| ischaemic stroke | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
|
| sciatica | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
|
| syncope | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
|
| depression | Psychiatric disorders | MedDRA (8.0) | Systematic Assessment |
|
| azotaemia | Renal and urinary disorders | MedDRA (8.0) | Systematic Assessment |
|
| chronic obstructive airways disease exacerbated | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| lymphadenopathy | Blood and lymphatic system disorders | MedDRA (8.0) | Systematic Assessment |
|
| atrial fibrillation | Cardiac disorders | MedDRA (8.0) | Systematic Assessment |
|
| bradycardia | Cardiac disorders | MedDRA (8.0) | Systematic Assessment |
|
| coronary artery disease | Cardiac disorders | MedDRA (8.0) | Systematic Assessment |
|
| palpitations | Cardiac disorders | MedDRA (8.0) | Systematic Assessment |
|
| tricuspid valve incompetence | Cardiac disorders | MedDRA (8.0) | Systematic Assessment |
|
| vertigo | Ear and labyrinth disorders | MedDRA (8.0) | Systematic Assessment |
|
| conjunctival haemorrhage | Eye disorders | MedDRA (8.0) | Systematic Assessment |
|
| vision blurred | Eye disorders | MedDRA (8.0) | Systematic Assessment |
|
| abdominal pain | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| abdominal pain upper | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| diarrhoea | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| dyspepsia | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| nausea | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| oesophagitis | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| toothache | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| vomiting | Gastrointestinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| asthenia | General disorders | MedDRA (8.0) | Systematic Assessment |
|
| chest discomfort | General disorders | MedDRA (8.0) | Systematic Assessment |
|
| chest pain | General disorders | MedDRA (8.0) | Systematic Assessment |
|
| chills | General disorders | MedDRA (8.0) | Systematic Assessment |
|
| fatigue | General disorders | MedDRA (8.0) | Systematic Assessment |
|
| influenza like illness | General disorders | MedDRA (8.0) | Systematic Assessment |
|
| infusion site pain | General disorders | MedDRA (8.0) | Systematic Assessment |
|
| non-cardiac chest pain | General disorders | MedDRA (8.0) | Systematic Assessment |
|
| oedema peripheral | General disorders | MedDRA (8.0) | Systematic Assessment |
|
| pyrexia | General disorders | MedDRA (8.0) | Systematic Assessment |
|
| drug hypersensitivity | Immune system disorders | MedDRA (8.0) | Systematic Assessment |
|
| bronchitis | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
|
| bronchitis acute | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
|
| eye infection | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
|
| herpes zoster | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
|
| influenza | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
|
| infusion site infection | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
|
| localised infection | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
|
| lower respiratory tract infection | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
|
| nasopharyngitis | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
|
| pharyngitis | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
|
| respiratory tract infection | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
|
| sinusitis | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
|
| upper respiratory tract infection | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
|
| urinary tract infection | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
|
| viral upper respiratory tract infection | Infections and infestations | MedDRA (8.0) | Systematic Assessment |
|
| contusion | Injury, poisoning and procedural complications | MedDRA (8.0) | Systematic Assessment |
|
| fall | Injury, poisoning and procedural complications | MedDRA (8.0) | Systematic Assessment |
|
| post procedural pain | Injury, poisoning and procedural complications | MedDRA (8.0) | Systematic Assessment |
|
| excercise capacity decreased | Investigations | MedDRA (8.0) | Systematic Assessment |
|
| international normalised ratio increased | Investigations | MedDRA (8.0) | Systematic Assessment |
|
| weight increased | Investigations | MedDRA (8.0) | Systematic Assessment |
|
| dehydration | Metabolism and nutrition disorders | MedDRA (8.0) | Systematic Assessment |
|
| fluid retention | Metabolism and nutrition disorders | MedDRA (8.0) | Systematic Assessment |
|
| hypokalaemia | Metabolism and nutrition disorders | MedDRA (8.0) | Systematic Assessment |
|
| hypomagnesaemia | Metabolism and nutrition disorders | MedDRA (8.0) | Systematic Assessment |
|
| arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Systematic Assessment |
|
| back pain | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Systematic Assessment |
|
| neck pain | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Systematic Assessment |
|
| pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Systematic Assessment |
|
| pain in jaw | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Systematic Assessment |
|
| shoulder pain | Musculoskeletal and connective tissue disorders | MedDRA (8.0) | Systematic Assessment |
|
| dizziness | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
|
| dizziness postural | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
|
| headache | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
|
| tremor | Nervous system disorders | MedDRA (8.0) | Systematic Assessment |
|
| anxiety | Psychiatric disorders | MedDRA (8.0) | Systematic Assessment |
|
| depression | Psychiatric disorders | MedDRA (8.0) | Systematic Assessment |
|
| insomnia | Psychiatric disorders | MedDRA (8.0) | Systematic Assessment |
|
| cough | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| crackles lung | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| dyspnoea exacerbated | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| dyspnoea exertional | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| hypoxia | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| pleuritic pain | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| pulmonary hypertension | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| rales | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| wheezing | Respiratory, thoracic and mediastinal disorders | MedDRA (8.0) | Systematic Assessment |
|
| dry skin | Skin and subcutaneous tissue disorders | MedDRA (8.0) | Systematic Assessment |
|
| erythema | Skin and subcutaneous tissue disorders | MedDRA (8.0) | Systematic Assessment |
|
| pruritis | Skin and subcutaneous tissue disorders | MedDRA (8.0) | Systematic Assessment |
|
| rash | Skin and subcutaneous tissue disorders | MedDRA (8.0) | Systematic Assessment |
|
| rash macular | Skin and subcutaneous tissue disorders | MedDRA (8.0) | Systematic Assessment |
|
| flushing | Vascular disorders | MedDRA (8.0) | Systematic Assessment |
|
| hypotension | Vascular disorders | MedDRA (8.0) | Systematic Assessment |
|
Not provided
| D002318 |
| Cardiovascular Diseases |
| Title | Measurements |
|---|---|
|