Trial · NCT01292551
Study of Placebo or Bosentan to Treat Patients With Single Ventricle Physiology.
NCT01292551, Phase 2, Completed, Copenhagen University Hospital, Rigshospitalet
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Study of Placebo or Bosentan to Treat Patients With Single Ventricle Physiology. Trials, record NCT01292551. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01292551
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Study of Placebo or Bosentan to Treat Patients With Single Ventricle Physiology.
- NCT number
- NCT01292551
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 75 participants, actual
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Conditions
- Hypoplastic Left Heart Syndrome, Tricuspid Atresia, Other Specified Congenital Anomalies of Heart
- Interventions
- Bosentan, Placebo
- First posted
- 2011-02-09
- Last updated
- 2013-04-19
- Other registries' IDs
- eudract:2010-022389-28
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change from baseline in VO2max at 14 weeks | Baseline and 14 weeks | Maximal O2 uptake in ml/min/kg in ergometer bicycle test |
| Secondary | Change from baseline in blood samples at 14 weeks | Baseline and 14 weeks | blood samples measured: plasma CT pro endothelin-1, IgG, IgA, NT pro BNP, albumin, free protein |
| Secondary | Change from baseline in SF36 questionnaire score at 14 weeks | Baseline and 14 weeks | SF36 quality of life interview |
| Secondary | Change from baseline in feces alfa 1 antitrypsin at 14 weeks | Baseline and 14 weeks | Fecal alfa 1 antitrypsin in mg/g |
| Secondary | Number of participants with adverse events | 2, 6, 10 and 14 weeks after start of treatment | general interview on adverse effects, and questions with special focus on typical adverse effects in Bosentan |
| Secondary | Change from baseline in vital signs | Baseline, 2, 6, 10 and 14 weeks | Systemic bloodpressure in mmHg, Pulse in min-1, Oxygen saturation in percent |
| Secondary | Change from baseline in control blood samples | Baseline, 2, 6, 10 and 14 weeks | Liver and renal biomarkers, Hb, PCV, trc and hCG for women |
| Secondary | Change from baseline in cardiac output/pulmonary blood flow | Baseline and 14 weeks | CO measured by Stringer Wassermann method during ergometer bicycle test |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
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 totals0
The totals the trial posted for each group.
None in this release.
Papers2
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/NCT01292551
GET https://conductscience.org/api/trials/v1/NCT01292551/registered