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Study ending due to lack of enrollment.
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| Name | Class |
|---|---|
| Ochsner Health System | OTHER |
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The purpose of this study is to learn more about the safety and effects of switching treatments from bosentan (Tracleer) or macientan (Opsumit) to ambrisentan (Letairis) over 24 weeks in subjects with Connective Tissue Disease associated Pulmonary Arterial Hypertension (CTD-PAH).
The study will consist of a group of subjects who have been on bosentan for at least three months and a group that has been on macitentan for at least three months. Both groups will be switched to Letairis 5mg daily after the bosentan or macitentan therapy for three months and then increased to a dose of Letairis 10mg daily at week 4 if well tolerated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Switch to Letairis from Bosentan | Experimental | Subjects will be switching treatments from Bosentan (Tracleer) to Ambrisentan (Letairis) |
|
| Switch to Letairis from Macitentan | Experimental | Subjects will be switching treatments from Macitentan (Opsumit) to Ambrisentan (Letairis) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ambrisentan | Drug | At entry to the study following the screen visits, patients will be switched from bosentan to ambrisentan to complete a 24 week trial. The only study intervention will be ambrisentan. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Stroke Volume | Echocardiography is used to estimate the stroke volume, or the amount of blood ejected from the heart with each beat. An average over three beats is used for the estimate and is reported as ml/beat. | Baseline and 24 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in EmPHasis-10 Score | Questionnaire-. The questionnaire is designed to determine how pulmonary hypertension affects the patient's life by asking 10 questions which address breathlessness, fatigue, control, and confidence. emPHasis-10 consists of 10 items which address breathlessness, fatigue, control and confidence. Each item is scored on a semantic differential six-point scale (0-5), with contrasting adjectives at each end. A total emPHasis-10 score is derived using simple aggregation of the 10 items. emPHasis-10 scores range from 0 to 50, higher scores indicate worse quality of life. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Terrill Huggins, MD | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ochsner Medical Center | New Orleans | Louisiana | 70121 | United States | ||
| Medical University of South Carolina |
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| ID | Title | Description |
|---|---|---|
| FG000 | Switch to Letairis From Bosentan | Subjects will be switching treatments from Bosentan (Tracleer) to Ambrisentan (Letairis) Ambrisentan: At entry to the study following the screen visits, patients will be switched from bosentan to ambrisentan to complete a 24 week trial. The only study intervention will be ambrisentan. |
| FG001 | Switch to Letairis From Macitentan | Subjects will be switching treatments from Macitentan (Opsumit) to Ambrisentan (Letairis) Ambrisentan: At entry to the study following the screen visits, patients will be switched from bosentan to ambrisentan to complete a 24 week trial. The only study intervention will be ambrisentan. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Switch to Letairis From Bosentan | Subjects will be switching treatments from Bosentan (Tracleer) to Ambrisentan (Letairis) Ambrisentan: At entry to the study following the screen visits, patients will be switched from bosentan to ambrisentan to complete a 24 week trial. The only study intervention will be ambrisentan. |
| BG001 |
| 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 | Change in Stroke Volume | Echocardiography is used to estimate the stroke volume, or the amount of blood ejected from the heart with each beat. An average over three beats is used for the estimate and is reported as ml/beat. | Posted | Mean | Standard Deviation | ml/beat | Baseline and 24 Weeks |
|
24 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 | Switch to Letairis From Bosentan | Subjects will be switching treatments from Bosentan (Tracleer) to Ambrisentan (Letairis) Ambrisentan: At entry to the study following the screen visits, patients will be switched from bosentan to ambrisentan to complete a 24 week trial. The only study intervention will be ambrisentan. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening hypoxemia due to pneumonia treated with a Z-pack | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Mild severity and unrelated to study medication or Study related procedures (MRN 1411151) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| John Terrill Huggins | Medical University of South Carolina | (843) 792-2296 | hugginjt@musc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 18, 2016 | Feb 1, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000081029 | Pulmonary Arterial Hypertension |
| ID | Term |
|---|---|
| D006976 | Hypertension, Pulmonary |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C467894 | ambrisentan |
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|
| Baseline and 24 Weeks |
| Disease Status as Measured by Change in Biomarker | NT-proBNP Biomarker: BNP is released from cardiac cells in response to increased pressure. The higher the value the worse the disease status. | Baseline and 12 Weeks |
| Charleston |
| South Carolina |
| 29425 |
| United States |
| Switch to Letairis From Macitentan |
Subjects will be switching treatments from Macitentan (Opsumit) to Ambrisentan (Letairis) Ambrisentan: At entry to the study following the screen visits, patients will be switched from bosentan to ambrisentan to complete a 24 week trial. The only study intervention will be ambrisentan. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
|
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| Secondary | Change in EmPHasis-10 Score | Questionnaire-. The questionnaire is designed to determine how pulmonary hypertension affects the patient's life by asking 10 questions which address breathlessness, fatigue, control, and confidence. emPHasis-10 consists of 10 items which address breathlessness, fatigue, control and confidence. Each item is scored on a semantic differential six-point scale (0-5), with contrasting adjectives at each end. A total emPHasis-10 score is derived using simple aggregation of the 10 items. emPHasis-10 scores range from 0 to 50, higher scores indicate worse quality of life. | Second patient in second arm did not complete questionnaire in week 24 | Posted | Mean | Standard Deviation | units on a scale | Baseline and 24 Weeks |
|
|
|
| Secondary | Disease Status as Measured by Change in Biomarker | NT-proBNP Biomarker: BNP is released from cardiac cells in response to increased pressure. The higher the value the worse the disease status. | Neither subject in group 2 completed week 24 assessment for this outcome so we are reporting changes at week 12 compared to baseline. | Posted | Mean | Standard Deviation | pg/mL | Baseline and 12 Weeks |
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| 0 |
| 1 |
| 0 |
| 1 |
| 1 |
| 1 |
| EG001 | Switch to Letairis From Macitentan | Subjects will be switching treatments from Macitentan (Opsumit) to Ambrisentan (Letairis) Ambrisentan: At entry to the study following the screen visits, patients will be switched from bosentan to ambrisentan to complete a 24 week trial. The only study intervention will be ambrisentan. | 0 | 2 | 0 | 2 | 0 | 2 |
|
| Chest pain and worsening PAH | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment |
|
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