Trial · NCT01093885
Study of Ambrisentan With Antifibrotic Agent Combination Therapy in Diffuse Systemic Sclerosis
NCT01093885, Not applicable, Completed, University of Pennsylvania; results first posted 2018-11-29
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Ambrisentan With Antifibrotic Agent Combination Therapy in Diffuse Systemic Sclerosis. Trials, record NCT01093885. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01093885
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Ambrisentan With Antifibrotic Agent Combination Therapy in Diffuse Systemic Sclerosis
- NCT number
- NCT01093885
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 15 participants, actual
- Lead sponsor
- University of Pennsylvania
- Conditions
- Systemic Sclerosis, Scleroderma
- Interventions
- Ambrisentan
- First posted
- 2010-03-26
- Last updated
- 2018-11-29
- Results first posted
- 2018-11-29
- Limitations and caveats
- Dose escalation was attempted however none of the patients were able to increase. Therefore all subjects remained on 5 mg daily throughout the study.
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | The Benefit That an Antifibrotic Agent and Ambrisentan Combination Have on the Cutaneous Involvement of Patients With Early Diffuse Systemic Sclerosis by Utilizing the MRSS | Baseline and 12 months | Using validated clinical response measurements such as the modified Rodnan skin score (MRSS) we will determine whether combination therapy will effect morbidity in systemic sclerosis. The modified Rodnan skin score has a range from 0-51 with higher numbers being worse skin involvement. |
| Secondary | Systemic Sclerosis Quality of Life Assessed by the SF-36. | Baseline vs Month 12. | The SF-36 form is a patient reported survey of patient health. The comparison status was analyzed between baseline and 12 months. The SF-36 has a range of 0-100 with higher numbers suggestive of better patient health |
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 | The Benefit That an Antifibrotic Agent and Ambrisentan Combination Have on the Cutaneous Involvement of Patients With Early Diffuse Systemic Sclerosis by Utilizing the MRSS | Baseline and 12 months | units on a scale | MEAN | |
| SECONDARY | Systemic Sclerosis Quality of Life Assessed by the SF-36. | Baseline vs Month 12. | 15 subjects enrolled, 5 subjects withdrew. Data analyzed was only for the 10 subjects who completed the 12 month visit and had both a baseline and a 12 month SF-36 form completed | units on a scale | 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 |
|---|---|---|---|---|---|
| The Benefit That an Antifibrotic Agent and Ambrisentan Combination Have on the Cutaneous Involvement of Patients With Early Diffuse Systemic Sclerosis by Utilizing the MRSS | Open Label: Medication Ambrisentan | mRss mean for group at study entry | 21 | Standard Deviation 7.4 | units on a scale |
| The Benefit That an Antifibrotic Agent and Ambrisentan Combination Have on the Cutaneous Involvement of Patients With Early Diffuse Systemic Sclerosis by Utilizing the MRSS | Open Label: Medication Ambrisentan | mRss mean for group at end of Study- to 12 months | 13 | Standard Deviation 11.2 | units on a scale |
| Systemic Sclerosis Quality of Life Assessed by the SF-36. | Open Label: Medication Ambrisentan | SF-36 mean for group at study entry | 62 | Standard Deviation 23.3 | units on a scale |
| Systemic Sclerosis Quality of Life Assessed by the SF-36. | Open Label: Medication Ambrisentan | SF-36 mean of group at study end -12 months | 65.9 | Standard Deviation 25.7 | units 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 | Open Label: Medication Ambrisentan | 15 | |
| Overall Study | COMPLETED | Open Label: Medication Ambrisentan | 10 | |
| Overall Study | NOT COMPLETED | Open Label: Medication Ambrisentan | 5 |
Source ClinicalTrials.gov
Adverse events33
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 | Hypertension | Cardiac disorders | Open Label: Medication Ambrisentan | 1 | 15 | 1 |
| other | Flu | Immune system disorders | Open Label: Medication Ambrisentan | 1 | 15 | 1 |
| other | Sore throat | Infections and infestations | Open Label: Medication Ambrisentan | 1 | 15 | 1 |
| other | Gastrointestinal illness | Gastrointestinal disorders | Open Label: Medication Ambrisentan | 3 | 15 | 3 |
| other | Rash | Skin and subcutaneous tissue disorders | Open Label: Medication Ambrisentan | 2 | 15 | 2 |
| other | Urinary Tract Infection | Infections and infestations | Open Label: Medication Ambrisentan | 1 | 15 | 3 |
| other | Nasal congestion | Infections and infestations | Open Label: Medication Ambrisentan | 3 | 15 | 3 |
| other | Headache | Nervous system disorders | Open Label: Medication Ambrisentan | 1 | 15 | 1 |
| other | Hot flashes | General disorders | Open Label: Medication Ambrisentan | 1 | 15 | 1 |
| other | Facial Flushing | General disorders | Open Label: Medication Ambrisentan | 1 | 15 | 1 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Open Label: Medication Ambrisentan | 0 | 15 |
| Total, other adverse events | Open Label: Medication Ambrisentan | 15 | 15 |
| Total, serious adverse events | Open Label: Medication Ambrisentan | 4 | 15 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30886964 | 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/NCT01093885
GET https://conductscience.org/api/trials/v1/NCT01093885/events?page=2