Trial · NCT01072669
Efficacy of Ambrisentan in Limited Scleroderma Patients in Improving Blood Flow to Hands or Feet
NCT01072669, Not applicable, Completed, Soumya Chatterjee; results first posted 2013-05-03
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy of Ambrisentan in Limited Scleroderma Patients in Improving Blood Flow to Hands or Feet. Trials, record NCT01072669. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01072669
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy of Ambrisentan in Limited Scleroderma Patients in Improving Blood Flow to Hands or Feet
- NCT number
- NCT01072669
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 20 participants, actual
- Lead sponsor
- Soumya Chatterjee
- Conditions
- Ischemia
- Interventions
- ambrisentan
- First posted
- 2010-02-22
- Last updated
- 2013-05-03
- Results first posted
- 2013-05-03
- Limitations and caveats
Small sample size and short duration of study Some patients had hand contractures which made the LDPI images somewhat inaccurate Could not adjust for all variables in final analysis Placebo effect reflected in patient responses to questionnaires
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Digital Micro-vascular Flow | Baseline and 12 weeks | Change in digital micro-vascular flow measured by LDPI in patients with Raynaud's phenomenon (RP) and digital ischemia secondary to SSc at 1 week and 12 weeks |
Source ClinicalTrials.gov
Outcomes1
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Digital Micro-vascular Flow | Baseline and 12 weeks | Assuming a standard deviation of 0.40, and use of a two-sample t-test with significance level of 0.05, there will be 80% power to detect differences in the change from baseline of at least 0.65 units if moderate correlation (r=0.50) exists, and 0.45 units if strong correlation (r=0.75) exists between treated | perfusion unit | MEAN |
Source ClinicalTrials.gov
Results by group4
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Digital Micro-vascular Flow | Ambrisentan | 1 week | .11 | 95% Confidence Interval -0.15 to 0.37 | perfusion unit |
| Digital Micro-vascular Flow | Sugar Pill | 1 week | .18 | 95% Confidence Interval -.27 to .63 | perfusion unit |
| Digital Micro-vascular Flow | Ambrisentan | 12 weeks | -.01 | 95% Confidence Interval -0.28 to .25 | perfusion unit |
| Digital Micro-vascular Flow | Sugar Pill | 12 weeks | -.06 | 95% Confidence Interval -0.51 to .39 | perfusion unit |
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 | Ambrisentan | 15 | |
| Overall Study | STARTED | Sugar Pill | 5 | |
| Overall Study | COMPLETED | Ambrisentan | 15 | |
| Overall Study | COMPLETED | Sugar Pill | 5 | |
| Overall Study | NOT COMPLETED | Ambrisentan | 0 | |
| Overall Study | NOT COMPLETED | Sugar Pill | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Ambrisentan | ||
| Total, all-cause mortality | Sugar Pill | ||
| Total, other adverse events | Ambrisentan | 0 | 15 |
| Total, other adverse events | Sugar Pill | 0 | 5 |
| Total, serious adverse events | Ambrisentan | 0 | 15 |
| Total, serious adverse events | Sugar Pill | 0 | 5 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 25876611 | 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 comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| Ambrisentan vs Sugar Pill: serious adverse events |
Source 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/NCT01072669
GET https://conductscience.org/api/trials/v1/NCT01072669/registered