Trial · NCT00377455
Placebo Controlled Trial of Bosentan in Scleroderma Patients
NCT00377455, Phase 2, Terminated, Georgetown University; results first posted 2011-07-20
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Placebo Controlled Trial of Bosentan in Scleroderma Patients. Trials, record NCT00377455. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00377455
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Placebo Controlled Trial of Bosentan in Scleroderma Patients
- NCT number
- NCT00377455
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 5 participants, actual
- Lead sponsor
- Georgetown University
- Conditions
- Systemic Scleroderma, Pulmonary Hypertension
- Interventions
- Bosentan, Placebo
- First posted
- 2006-09-18
- Last updated
- 2018-05-24
- Results first posted
- 2011-07-20
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Total Exercise Time on the Exercise Echocardiogram Using the Standard Bruce Stress Protocol. | This will be determined after 16 weeks on the study medication. | The total exercise time measured using the exercise echocardiogram is evaluated with the standard Bruce Stress Protocol, and this will be determined after 16 weeks on the study medication. |
| Secondary | 6-minute Walk Distance | 16 weeks | The distance walked during a 6-minute walk test. |
| Secondary | Brain Natriuretic Peptide (BNP) Level | 16 weeks | Serum BNP level to evaluate Brain Natriuretic Peptide (BNP) level |
| Secondary | Endothelin-1(ET-1) Level | 16 weeks | From saved serum to determine Endothelian-1 (ET-1) levels in patients |
| Secondary | Quality of Life (QOL) | 16 weeks | QOL is measured using the Short Form 36 Health Survey (SF-36, which measures health on eight dimensions: general health perception, physical and social functioning, role limitations by physical or emotional problems, mental health, vitality, and bodily pain. For each dimension items are coded, summed, and transformed on to a scale from 0 (worst health) to 100 (best health). |
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 | Total Exercise Time on the Exercise Echocardiogram Using the Standard Bruce Stress Protocol. | This will be determined after 16 weeks on the study medication. | |||
| SECONDARY | 6-minute Walk Distance | 16 weeks | Outcomes not available, due to early termination of study | ||
| SECONDARY | Brain Natriuretic Peptide (BNP) Level | 16 weeks | Outcomes not available, due to early termination of study | ||
| SECONDARY | Endothelin-1(ET-1) Level | 16 weeks | Outcomes not available, due to early termination of study | ||
| SECONDARY | Quality of Life (QOL) | 16 weeks | Outcomes not available, due to early termination of study |
Source ClinicalTrials.gov
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Bosentan and Placebo Arms | 5 | |
| Overall Study | COMPLETED | Bosentan and Placebo Arms | 4 | |
| Overall Study | NOT COMPLETED | Bosentan and Placebo Arms | 1 |
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 totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Bosentan and Placebo Arms | ||
| Total, other adverse events | Bosentan and Placebo Arms | 0 | 5 |
| Total, serious adverse events | Bosentan and Placebo Arms | 0 | 5 |
Source ClinicalTrials.gov
Papers7
The papers the trial lists on ClinicalTrials.gov.
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/NCT00377455
GET https://conductscience.org/api/trials/v1/NCT00377455/registered