Trial · NCT01169519
Sildenafil in Single Ventricle Patients
NCT01169519, Phase 1, Completed, Duke University; results first posted 2013-12-05
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Sildenafil in Single Ventricle Patients. Trials, record NCT01169519. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01169519
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Sildenafil in Single Ventricle Patients
- NCT number
- NCT01169519
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 21 participants, actual
- Lead sponsor
- Duke University
- Conditions
- Heart Disease
- Interventions
- Sildenafil by injection, Sildenafil by injection, Sildenafil by injection, Sildenafil by injection
- First posted
- 2010-07-26
- Last updated
- 2013-12-05
- Results first posted
- 2013-12-05
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Sildenafil Plasma Concentration | 5 minutes after completion of sildenafil infusion | Assessment of peak sildenafil plasma concentration. |
| Secondary | Hemodynamic Safety and Efficacy | 10 minutes after completion of sildenafil infusion | Assessment of pulmonary vascular resistance |
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 | Maximum Sildenafil Plasma Concentration | 5 minutes after completion of sildenafil infusion | 3 patients were enrolled in this group but in 1 participant, an inadequate plasma sample volume prevented accurate determination of sildenafil concentration. | ng/mL | MEAN |
| SECONDARY | Hemodynamic Safety and Efficacy | 10 minutes after completion of sildenafil infusion | Wood units * m^2 | MEDIAN |
Source ClinicalTrials.gov
Results by group6
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Sildenafil Plasma Concentration | Peak Sildenafil Level (ng/mL) for Dose = 0.125mg/kg | 181 | Standard Deviation 126 | ng/mL | |
| Maximum Sildenafil Plasma Concentration | Peak Sildenafil Level (ng/mL) for Dose = 0.35mg/kg | 515 | Standard Deviation 98 | ng/mL | |
| Maximum Sildenafil Plasma Concentration | Peak Sildenafil Level (ng/mL) for Dose = 0.45mg/kg | 545 | Standard Deviation 185 | ng/mL | |
| Maximum Sildenafil Plasma Concentration | Peak Sildenafil Level (ng/mL) for Dose = 0.25mg/kg | 202 | Standard Deviation 92 | ng/mL | |
| Hemodynamic Safety and Efficacy | Baseline | 2.3 | Inter-Quartile Range 1.7 to 3.0 | Wood units * m^2 | |
| Hemodynamic Safety and Efficacy | Sildenafil | 1.6 | Inter-Quartile Range 1.2 to 2.0 | Wood units * m^2 |
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 | Baseline/Sildenafil | 21 | |
| Overall Study | COMPLETED | Baseline/Sildenafil | 21 | |
| Overall Study | NOT COMPLETED | Baseline/Sildenafil | 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 totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose = 0.125mg/kg | ||
| Total, all-cause mortality | Dose = 0.25mg/kg | ||
| Total, all-cause mortality | Dose = 0.35mg/kg | ||
| Total, all-cause mortality | Dose = 0.45mg/kg | ||
| Total, other adverse events | Dose = 0.125mg/kg | 0 | 3 |
| Total, other adverse events | Dose = 0.25mg/kg | 0 | 5 |
| Total, other adverse events | Dose = 0.35mg/kg | 0 | 8 |
| Total, other adverse events | Dose = 0.45mg/kg | 0 | 5 |
| Total, serious adverse events | Dose = 0.125mg/kg | 0 | 3 |
| Total, serious adverse events | Dose = 0.25mg/kg | 0 | 5 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers2
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/NCT01169519
GET https://conductscience.org/api/trials/v1/NCT01169519/registered