Trial · NCT01224210
Ambrisentan in Patients With Porto-pulmonary Hypertension A Multicenter Open Label Trial
NCT01224210, Phase 3, Completed, Tufts Medical Center; results first posted 2021-01-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Ambrisentan in Patients With Porto-pulmonary Hypertension A Multicenter Open Label Trial. Trials, record NCT01224210. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01224210
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ambrisentan in Patients With Porto-pulmonary Hypertension A Multicenter Open Label Trial
- NCT number
- NCT01224210
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 30 participants, actual
- Lead sponsor
- Tufts Medical Center
- Conditions
- Portopulmonary Hypertension
- Interventions
- Ambrisentan
- First posted
- 2010-10-19
- Last updated
- 2021-01-12
- Results first posted
- 2021-01-12
- Limitations and caveats
- Standardization of the 6 Minute Walk Test
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Pulmonary Vascular Resistance | from baseline to Week 24 | Change in Pulmonary Vascular Resistance from baseline to Week 24 for all patients (using cardiac output \[CO\] measured by the thermodilution method and reported as percent difference from baseline). |
| Primary | 6 Minute Walk Distance | Change from baseline to Week 24 | Change from baseline in 6 Minute Walk Distance to Week 24 for all patients. (difference measured in meters). |
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 | Change in Pulmonary Vascular Resistance | from baseline to Week 24 | percent difference from baseline | MEAN | |
| PRIMARY | 6 Minute Walk Distance | Change from baseline to Week 24 | meters | MEAN |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Pulmonary Vascular Resistance | Ambrisentan | 7.1 | Standard Deviation 5 | percent difference from baseline | |
| 6 Minute Walk Distance | Group 1 PAH With PoPH | Baseline | 314 | Standard Deviation 94 | meters |
| 6 Minute Walk Distance | Group 1 PAH With PoPH | Week 24 | 336 | Standard Deviation 108 | 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 (24 Weeks), Extension (4 Weeks) | 30 | |
| Overall Study | COMPLETED | Ambrisentan (24 Weeks), Extension (4 Weeks) | 23 | |
| Overall Study | NOT COMPLETED | Ambrisentan (24 Weeks), Extension (4 Weeks) | 7 |
Source ClinicalTrials.gov
Adverse events3
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 | Leg Edema | Blood and lymphatic system disorders | Ambrisentan (24 Weeks), Extension (4 Weeks) | 1 | 30 | 1 |
| serious | Edema | Respiratory, thoracic and mediastinal disorders | Ambrisentan (24 Weeks), Extension (4 Weeks) | 11 | 30 | 11 |
| serious | Headache | Musculoskeletal and connective tissue disorders | Ambrisentan (24 Weeks), Extension (4 Weeks) | 3 | 30 | 3 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ambrisentan (24 Weeks), Extension (4 Weeks) | 4 | 30 |
| Total, other adverse events | Ambrisentan (24 Weeks), Extension (4 Weeks) | 1 | 30 |
| Total, serious adverse events | Ambrisentan (24 Weeks), Extension (4 Weeks) | 14 | 30 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 32008947 | DERIVED |
Source PubMed
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/NCT01224210
GET https://conductscience.org/api/trials/v1/NCT01224210/registered