Trial · NCT01042158
A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic Sclerosis
NCT01042158, Phase 4, Completed, Johns Hopkins University; results first posted 2017-09-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic Sclerosis. Trials, record NCT01042158. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01042158
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Clinical Trial of Ambrisentan and Tadalafil in Pulmonary Arterial Hypertension Associated With Systemic Sclerosis
- NCT number
- NCT01042158
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 25 participants, actual
- Lead sponsor
- Johns Hopkins University
- Conditions
- Pulmonary Arterial Hypertension, Systemic Sclerosis, Scleroderma Spectrum of Diseases, Connective Tissue Disease, Pulmonary Hypertension
- Interventions
- tadalafil and ambrisentan upfront combination therapy
- First posted
- 2010-01-05
- Last updated
- 2017-09-12
- Results first posted
- 2017-09-12
- Limitations and caveats
1. An open-label study with no placebo group~2. Relatively small number of patients and therefore vulnerable to confounding natural history with treatment effects~3. Measurements performed at four different institutions~4. Few missing data
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Right Ventricular (RV) Mass | baseline and 36 weeks | Assessment of change in Right ventricular mass was done via standard volumetric cine images of the right heart at baseline and comparing it to that at the end of 36 weeks using Cardiac Magnetic Resonance Imaging studies. |
| Primary | Pulmonary Vascular Resistance (PVR) | baseline 36 weeks | Change in Pulmonary Vascular Resistance (PVR) was ascertained via Right Heart Catheterization (RHC) measurement of the difference between the PVR at baseline and 36 weeks |
| Secondary | Tricuspid Annular Plane Systolic Excursion (TAPSE) | baseline and 36 weeks | The extent of displacement of the tricuspid valves, termed as Tricuspid Annular Plane Systolic Excursion (TAPSE) was measured using a trans-thoracic echocardiogram following Right heart catheterization. |
| Secondary | 6-minute Walk Distance | baseline and 36 weeks | patients were made to take a walk of normal speed to cover a distance in 6 minutes and distance covered was recorded. This was done at baseline (week o) and then repeated t 36 weeks. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Right Ventricular (RV) Mass | baseline and 36 weeks | grams | MEDIAN | |
| PRIMARY | Pulmonary Vascular Resistance (PVR) | baseline 36 weeks | Wood units | MEDIAN | |
| SECONDARY | Tricuspid Annular Plane Systolic Excursion (TAPSE) | baseline and 36 weeks | cm | MEAN | |
| SECONDARY | 6-minute Walk Distance | baseline and 36 weeks | meters | MEAN |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Right Ventricular (RV) Mass | Tadalafil and Ambrisentan Upfront Therapy | Baseline | 32.5 | Inter-Quartile Range 23.2 to 41.4 | grams |
| Right Ventricular (RV) Mass | Tadalafil and Ambrisentan Upfront Therapy | At 36 weeks | 28.0 | Inter-Quartile Range 20.6 to 32.9 | grams |
| Pulmonary Vascular Resistance (PVR) | Tadalafil and Ambrisentan Upfront Therapy | Baseline | 6.9 | Inter-Quartile Range 4.0 to 12.9 | Wood units |
| Pulmonary Vascular Resistance (PVR) | Tadalafil and Ambrisentan Upfront Therapy | At 36 weeks | 3.1 | Inter-Quartile Range 2.0 to 5.7 | Wood units |
| Tricuspid Annular Plane Systolic Excursion (TAPSE) | Tadalafil and Ambrisentan Upfront Therapy | Baseline at week 0 | 2.2 | Standard Deviation 0.12 | cm |
| Tricuspid Annular Plane Systolic Excursion (TAPSE) | Tadalafil and Ambrisentan Upfront Therapy | week 36 | 1.65 | Standard Deviation 0.11 | cm |
| 6-minute Walk Distance | Tadalafil and Ambrisentan Upfront Therapy | Baseline (week 0) | 343 | Standard Deviation 131 | meters |
| 6-minute Walk Distance | Tadalafil and Ambrisentan Upfront Therapy | Week 36 | 395 | Standard Deviation 99 | 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 | Tadalafil and Ambrisentan Upfront Therapy | 25 | |
| Overall Study | COMPLETED | Tadalafil and Ambrisentan Upfront Therapy | 24 | |
| Overall Study | NOT COMPLETED | Tadalafil and Ambrisentan Upfront Therapy | 1 |
Source ClinicalTrials.gov
Adverse events1
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 |
|---|---|---|---|---|---|---|
| serious | Stenosis of the left internal carotid artery, worsening shortness of breath, Right heart failure | Cardiac disorders | Tadalafil and Ambrisentan Upfront Therapy | 3 | 24 | 3 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Tadalafil and Ambrisentan Upfront Therapy | 0 | 24 |
| Total, other adverse events | Tadalafil and Ambrisentan Upfront Therapy | 0 | 24 |
| Total, serious adverse events | Tadalafil and Ambrisentan Upfront Therapy | 3 | 24 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| P50HL084946 | Molecular Determinants of Pulmonary Arterial Hypertension | HASSOUN, PAUL M. | JOHNS HOPKINS UNIVERSITY | NATIONAL HEART, LUNG, AND BLOOD INSTITUTE | 2007 to 2011 |
Source NIH RePORTER
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/NCT01042158
GET https://conductscience.org/api/trials/v1/NCT01042158/registered