A Phase 4 interventional study of Ambrisentan in Pulmonary Arterial Hypertension, sponsored by Medical University of South Carolina. Terminated at 2 sites in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2019-04-08.
Sponsored by Medical University of South Carolina · Phase 4, Interventional, and Treatment
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.
761 studies on the registry are indexed under Pulmonary Arterial Hypertension; 142 are open to participants now.
This study's enrollment of 3 is below the median of 38 across 509 interventional studies indexed under Pulmonary Arterial Hypertension.
Browse Pulmonary Arterial Hypertension studies →Medical University of South Carolina is the lead sponsor of 852 studies on the registry; 165 are open to participants now.
Of its 128 completed or terminated interventional studies of FDA-regulated products, 101 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Subjects will be switching treatments from Bosentan (Tracleer) to Ambrisentan (Letairis)
Drug: Ambrisentan
Subjects will be switching treatments from Macitentan (Opsumit) to Ambrisentan (Letairis)
Drug: 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.
Also known as: Letairis
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.
Time frame: Baseline and 24 Weeks
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.
Time frame: 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.
Time frame: Baseline and 12 Weeks
| Milestone | Switch to Letairis From Bosentan | Switch to Letairis From Macitentan |
|---|---|---|
| Started | 1 | 2 |
| Completed | 1 | 2 |
| Not completed | 0 | 0 |
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.
| ml/beat | Switch to Letairis From Bosentan | Switch to Letairis From Macitentan |
|---|---|---|
| Change in Stroke Volume | -2.8 ± NA | 8.7 ± 4.2 |
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.
| units on a scale | Switch to Letairis From Bosentan | Switch to Letairis From Macitentan |
|---|---|---|
| Change in EmPHasis-10 Score | 3 ± NA | 4 ± NA |
NT-proBNP Biomarker: BNP is released from cardiac cells in response to increased pressure. The higher the value the worse the disease status.
| pg/mL | Switch to Letairis From Bosentan | Switch to Letairis From Macitentan |
|---|---|---|
| Disease Status as Measured by Change in Biomarker | 926 ± NA | -78 ± 362 |
Collected over 24 Weeks. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Switch to Letairis From Bosentan | 0/1 (0%) | 0/1 (0%) | 1/1 (100%) |
| Switch to Letairis From Macitentan | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Event | Switch to Letairis From Bosentan | Switch to Letairis From Macitentan |
|---|---|---|
| Worsening hypoxemia due to pneumonia treated with a Z-packRespiratory, thoracic and mediastinal disorders | 1/1 | 0/2 |
| Chest pain and worsening PAHRespiratory, thoracic and mediastinal disorders | 0/1 | 0/2 |
| Age, Categorical(Participants) | Switch to Letairis From Bosentan | Switch to Letairis From Macitentan | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 1 | 2 | 3 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Switch to Letairis From Bosentan | Switch to Letairis From Macitentan | Total |
|---|---|---|---|
| Mean | 53 (NA to NA) | 50.5 (44 to 57) | 51.33 (44 to 57) |
| Sex: Female, Male(Participants) | Switch to Letairis From Bosentan | Switch to Letairis From Macitentan | Total |
|---|---|---|---|
| Female | 1 | 2 | 3 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Switch to Letairis From Bosentan | Switch to Letairis From Macitentan | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 1 | 2 | 3 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Switch to Letairis From Bosentan | Switch to Letairis From Macitentan | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 1 | 2 | 3 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Switch to Letairis From Bosentan | Switch to Letairis From Macitentan | Total |
|---|---|---|---|
| United States | 1 | 2 | 3 |
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Pulmonary Arterial Hypertension→
Medical University of South Carolina