Trial · NCT02885012
Crossover Study From Macitentan or Bosentan Over to Ambrisentan
NCT02885012, Phase 4, Terminated, Medical University of South Carolina; results first posted 2019-04-08
3 sourcestrials-2026-11-12-0.4.0
Cite this record
ConductScience Library. Crossover Study From Macitentan or Bosentan Over to Ambrisentan. Trials, record NCT02885012. Release trials-2026-11-12-0.4.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02885012
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Crossover Study From Macitentan or Bosentan Over to Ambrisentan
- NCT number
- NCT02885012
- Status
- Terminated
- Phases
- Phase 4
- Enrollment
- 3 participants, actual
- Lead sponsor
- Medical University of South Carolina
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- Ambrisentan
- First posted
- 2016-08-31
- Last updated
- 2019-04-08
- Results first posted
- 2019-04-08
Source ClinicalTrials.gov
Registered outcomes3
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Stroke Volume | Baseline and 24 Weeks | 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. |
| Secondary | Change in EmPHasis-10 Score | Baseline and 24 Weeks | 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. |
| Secondary | Disease Status as Measured by Change in Biomarker | Baseline and 12 Weeks | NT-proBNP Biomarker: BNP is released from cardiac cells in response to increased pressure. The higher the value the worse the disease status. |
Source ClinicalTrials.gov
Outcomes3
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Stroke Volume | Baseline and 24 Weeks | ml/beat | MEAN | |
| SECONDARY | Change in EmPHasis-10 Score | Baseline and 24 Weeks | Second patient in second arm did not complete questionnaire in week 24 | units on a scale | MEAN |
| SECONDARY | Disease Status as Measured by Change in Biomarker | Baseline and 12 Weeks | Neither subject in group 2 completed week 24 assessment for this outcome so we are reporting changes at week 12 compared to baseline. | pg/mL | MEAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Stroke Volume | Switch to Letairis From Bosentan | -2.8 | Standard Deviation NA | ml/beat | |
| Change in Stroke Volume | Switch to Letairis From Macitentan | 8.7 | Standard Deviation 4.2 | ml/beat | |
| Change in EmPHasis-10 Score | Switch to Letairis From Bosentan | 3 | Standard Deviation NA | units on a scale | |
| Change in EmPHasis-10 Score | Switch to Letairis From Macitentan | 4 | Standard Deviation NA | units on a scale | |
| Disease Status as Measured by Change in Biomarker | Switch to Letairis From Bosentan | 926 | Standard Deviation NA | pg/mL | |
| Disease Status as Measured by Change in Biomarker | Switch to Letairis From Macitentan | -78 | Standard Deviation 362 | pg/mL |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Switch to Letairis From Bosentan | 1 | |
| Overall Study | STARTED | Switch to Letairis From Macitentan | 2 | |
| Overall Study | COMPLETED | Switch to Letairis From Bosentan | 1 | |
| Overall Study | COMPLETED | Switch to Letairis From Macitentan | 2 | |
| Overall Study | NOT COMPLETED | Switch to Letairis From Bosentan | 0 | |
| Overall Study | NOT COMPLETED | Switch to Letairis From Macitentan | 0 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Worsening hypoxemia due to pneumonia treated with a Z-pack | Respiratory, thoracic and mediastinal disorders | Switch to Letairis From Bosentan | 1 | 1 | 1 |
| other | Worsening hypoxemia due to pneumonia treated with a Z-pack | Respiratory, thoracic and mediastinal disorders | Switch to Letairis From Macitentan | 0 | 2 | 0 |
| other | Chest pain and worsening PAH | Respiratory, thoracic and mediastinal disorders | Switch to Letairis From Bosentan | 0 | 1 | 0 |
| other | Chest pain and worsening PAH | Respiratory, thoracic and mediastinal disorders | Switch to Letairis From Macitentan | 0 | 2 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Switch to Letairis From Bosentan | 0 | 1 |
| Total, all-cause mortality | Switch to Letairis From Macitentan | 0 | 2 |
| Total, other adverse events | Switch to Letairis From Bosentan | 1 | 1 |
| Total, other adverse events | Switch to Letairis From Macitentan | 0 | 2 |
| Total, serious adverse events | Switch to Letairis From Bosentan | 0 | 1 |
| Total, serious adverse events | Switch to Letairis From Macitentan | 0 | 2 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Switch to Letairis From Bosentan vs Switch to Letairis From Macitentan: deaths from any cause | Trial comparisons |
| Switch to Letairis From Bosentan vs Switch to Letairis From Macitentan: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02885012
GET https://conductscience.org/api/trials/v1/NCT02885012/registered