Trial · NCT01051960
Exercise Induced Pulmonary Hypertension in Systemic Sclerosis and Treatment With Ambrisentan
NCT01051960, Phase 4, Completed, University of California, Los Angeles; results first posted 2020-11-02
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Exercise Induced Pulmonary Hypertension in Systemic Sclerosis and Treatment With Ambrisentan. Trials, record NCT01051960. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01051960
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Exercise Induced Pulmonary Hypertension in Systemic Sclerosis and Treatment With Ambrisentan
- NCT number
- NCT01051960
- Status
- Completed
- Phases
- Phase 4
- Enrollment
- 12 participants, actual
- Lead sponsor
- University of California, Los Angeles
- Conditions
- Systemic Sclerosis, Shortness of Breath, Pulmonary Hypertension
- Interventions
- Ambrisentan
- First posted
- 2010-01-20
- Last updated
- 2020-11-02
- Results first posted
- 2020-11-02
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Exercise Pulmonary Hemodynamics From Baseline to Week 24 | 24 weeks | We defined ePH (exercise PH) as an mPAP of 30 mmHg, PCWP of 18 mm Hg, and a transpulmonary gradient (TPG) of 15 mm Hg, where TPG equals mPAP minus PCWP. We defined ePVH (exercise pulmonary venous hypertension) as an mPAP of 30 mm Hg, PCWP of 18 mm Hg, and a TPG of 15 mm Hg. We defined eoPH (exercise out of proportion) as an mPAP of 30 mm Hg, PCWP of 18 mm Hg, and a TPG of 15 mm Hg (4). Our hypothesis was that SSc patients with normal exercise physiology and ePVH have a different patho-physiology compared to patients with pulmonary vascular disease (ePH and eoPH). |
| Secondary | Change in Distance Walked in Six Minutes From Baseline to 24 Week | 24 weeks | ATS guideline based assessment with known minimally clinically important difference |
| Secondary | Quality of Life (QOL) Based on SF36 and HAQ-DI | 24 weeks | Number of participants exceeding minimally important difference estimates on changes in quality of life as assessed by SF-36 (short form 36) quality of life index with mental and physical component scores, or by HAQ-DI (health assessment questionnaire disability index) limitations that may be related to musculoskeletal limitations |
| Secondary | HAQ-DI (Health Assessment Questionnaire Disability Index) | 24 weeks | Assessing limitations that may be related to musculoskeletal limitations, the HAQ-DI assesses the difficulty a participant has had in the past week in 8 domains of daily living activities: dressing and grooming, arising, eating, walking, hygiene, reach, grip, and other activities. Each activity category consists of 2-3 items in which level of difficulty is scored from 0 to 3 with 0=no difficulty, 1=some difficulty, 2=much difficulty, and 3=unable to do. The 8 domain scores are averaged into a total HAQ-DI score ranging from 0 (no disability) to 3 (completely disabled). |
| Secondary | St. George's Respiratory Questionnaire | 24 weeks | To assess overall health, daily life, and perceived well-being in patients with underlying lung disease, the SGRQ is a health-related quality of life questionnaire divided into 3 components : symptoms, activity and impact. The total score (summed weights) can range from 0 to 100 with a lower score denoting a better health status. |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change in Exercise Pulmonary Hemodynamics From Baseline to Week 24 | 24 weeks | mmHg | MEAN | |
| SECONDARY | Change in Distance Walked in Six Minutes From Baseline to 24 Week | 24 weeks | meters | MEAN | |
| SECONDARY | Quality of Life (QOL) Based on SF36 and HAQ-DI | 24 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | HAQ-DI (Health Assessment Questionnaire Disability Index) | 24 weeks | score on a scale | MEAN | |
| SECONDARY | St. George's Respiratory Questionnaire | 24 weeks | score on a scale | MEAN |
Source ClinicalTrials.gov
Results by group5
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Exercise Pulmonary Hemodynamics From Baseline to Week 24 | Ambrisentan | 37.4 | Standard Deviation 8.3 | mmHg | |
| Change in Distance Walked in Six Minutes From Baseline to 24 Week | Ambrisentan | 44.5 | Standard Deviation 10.3 | meters | |
| Quality of Life (QOL) Based on SF36 and HAQ-DI | Ambrisentan | 0 | Participants | ||
| HAQ-DI (Health Assessment Questionnaire Disability Index) | Ambrisentan | 1.12 | Standard Deviation 0.02 | score on a scale | |
| St. George's Respiratory Questionnaire | Ambrisentan | 13.2 | Standard Deviation 11.7 | score on a scale |
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 | 12 | |
| Overall Study | COMPLETED | Ambrisentan | 11 | |
| Overall Study | NOT COMPLETED | Ambrisentan | 1 |
Source ClinicalTrials.gov
Adverse events13
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 | Upper respiratory symptoms | Respiratory, thoracic and mediastinal disorders | Ambrisentan | 2 | 12 | 2 |
| other | Nasal Congestion | Respiratory, thoracic and mediastinal disorders | Ambrisentan | 5 | 12 | 5 |
| other | Constipation | Gastrointestinal disorders | Ambrisentan | 1 | 12 | 1 |
| other | Joint and body pain | General disorders | Ambrisentan | 1 | 12 | 1 |
| other | Elevated liver function tests | Hepatobiliary disorders | Ambrisentan | 1 | 12 | 1 |
| other | Edema | Blood and lymphatic system disorders | Ambrisentan | 5 | 12 | 5 |
| other | Headache | General disorders | Ambrisentan | 1 | 12 | 1 |
| other | Tinea Corporis | Skin and subcutaneous tissue disorders | Ambrisentan | 1 | 12 | 1 |
| other | Allergic reaction | Immune system disorders | Ambrisentan | 1 | 12 | 1 |
| other | Bronchoalveolar carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Ambrisentan | 1 | 12 | 1 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ambrisentan | 0 | 12 |
| Total, other adverse events | Ambrisentan | 12 | 12 |
| Total, serious adverse events | Ambrisentan | 1 | 12 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 22777623 | RESULT |
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/NCT01051960
GET https://conductscience.org/api/trials/v1/NCT01051960/registered