Trial · NCT01330108
Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension
NCT01330108, Phase 4, Completed, University of Alabama at Birmingham; results first posted 2014-08-11
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension. Trials, record NCT01330108. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01330108
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safely Change From Bosentan to Ambrisentan in Pulmonary Hypertension
- NCT number
- NCT01330108
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 32 participants, actual
- Lead sponsor
- University of Alabama at Birmingham
- Conditions
- Pulmonary Arterial Hypertension
- Interventions
- ambrisentan
- First posted
- 2011-04-06
- Last updated
- 2014-08-11
- Results first posted
- 2014-08-11
- Limitations and caveats
There is bias in the study due to the fact that subjects have been proven to tolerate the initial drug in the study (bosentan) and adequate time was not allowed for subjects to be able to tolerate ambisentan
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Not Able to Tolerate Ambrisentan | baseline to 12 weeks | If a subject was not able tolerate ambrisentan, subject was returned to use of bosentan and ambrisentan was withdrawn within first 12 weeks of start. A subject was considered to not be able to tolerate ambrisentan if they experienced an adverse event or side effect that was not acceptable to the subject. |
| Secondary | Mean Change in Distance for a Six Minute Walk at 12 Weeks Post Start of Ambrisentan | baseline to 12 weeks | Evaluate the change in exercise tolerance. Measured the distance a subject was capable of walking in 6 minutes at basline compared to the distance at 12 weeks. The distance was measured in meters. A postive result reflects the distance increased at 12 weeks, a negative result reflects how much shorter the distance was. |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects Not Able to Tolerate Ambrisentan | baseline to 12 weeks | participants | NUMBER | |
| SECONDARY | Mean Change in Distance for a Six Minute Walk at 12 Weeks Post Start of Ambrisentan | baseline to 12 weeks | meters | MEAN |
Source ClinicalTrials.gov
Results by group2
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects Not Able to Tolerate Ambrisentan | Ambrisentan | 4 | participants | ||
| Mean Change in Distance for a Six Minute Walk at 12 Weeks Post Start of Ambrisentan | Ambrisentan | 368.71 | Full Range 190 to 510 | meters |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Ambrisentan | 32 | |
| Overall Study | COMPLETED | Ambrisentan | 28 | |
| Overall Study | NOT COMPLETED | Ambrisentan | 4 |
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 | edema | Cardiac disorders | Ambrisentan | 10 | 32 | 10 |
| other | rash | Skin and subcutaneous tissue disorders | Ambrisentan | 1 | 32 | 1 |
| other | rash, not attibuted to drug | Skin and subcutaneous tissue disorders | Ambrisentan | 1 | 32 | 1 |
| other | lower extremity edema | Cardiac disorders | Ambrisentan | 2 | 32 | 2 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ambrisentan | ||
| Total, other adverse events | Ambrisentan | 14 | 32 |
| Total, serious adverse events | Ambrisentan | 0 | 32 |
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT01330108
GET https://conductscience.org/api/trials/v1/NCT01330108/registered