Trial · NCT01290484
A Study to Evaluate Sildenafil for the Treatment of Lymphatic Malformations
NCT01290484, Phase 1, Phase 2, Completed, Stanford University; results first posted 2014-06-12
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Evaluate Sildenafil for the Treatment of Lymphatic Malformations. Trials, record NCT01290484. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01290484
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate Sildenafil for the Treatment of Lymphatic Malformations
- NCT number
- NCT01290484
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 7 participants, actual
- Lead sponsor
- Stanford University
- Conditions
- Lymphangioma
- Interventions
- Sildenafil
- First posted
- 2011-02-07
- Last updated
- 2015-06-19
- Results first posted
- 2014-06-12
- Limitations and caveats
- Baseline MRI examinations were performed within 6 months prior to commencement of sildenafil; several subjects took sildenafil for more than 20 weeks due to MRI scheduling and personal accommodations
Source ClinicalTrials.gov
Registered outcomes1
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change in Volume of Lymphatic Malformation | Baseline, 20 weeks | Participants were given sildenafil for 20 weeks. Participants weighing more than 20 kg were given 20 mg 3 times daily (60 mg/day). Participants weighing between 8 kg and 20 kg were given 10 mg 3 times daily (30 mg/day). |
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 | Change in Volume of Lymphatic Malformation | Baseline, 20 weeks | percentage of volume change | NUMBER |
Source ClinicalTrials.gov
Results by group7
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change in Volume of Lymphatic Malformation | Sildenafil | Subject 1 | 3.7 | percentage of volume change | |
| Change in Volume of Lymphatic Malformation | Sildenafil | Subject 2 | -4.3 | percentage of volume change | |
| Change in Volume of Lymphatic Malformation | Sildenafil | Subject 3 | -1.0 | percentage of volume change | |
| Change in Volume of Lymphatic Malformation | Sildenafil | Subject 4 | -31.7 | percentage of volume change | |
| Change in Volume of Lymphatic Malformation | Sildenafil | Subject 5 | -21.7 | percentage of volume change | |
| Change in Volume of Lymphatic Malformation | Sildenafil | Subject 6 | 1.1 | percentage of volume change | |
| Change in Volume of Lymphatic Malformation | Sildenafil | Subject 7 | 29.6 | percentage of volume change |
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 | Sildenafil | 7 | |
| Overall Study | COMPLETED | Sildenafil | 7 | |
| Overall Study | NOT COMPLETED | Sildenafil | 0 |
Source ClinicalTrials.gov
Adverse events13
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 | Nausea/indigestion | Gastrointestinal disorders | Sildenafil | 4 | 7 | |
| other | Rhinorrhea | Respiratory, thoracic and mediastinal disorders | Sildenafil | 3 | 7 | |
| other | Cough | Respiratory, thoracic and mediastinal disorders | Sildenafil | 3 | 7 | |
| other | Mild insomnia | Psychiatric disorders | Sildenafil | 3 | 7 | |
| other | Fever | Investigations | Sildenafil | 2 | 7 | |
| other | Emesis | Gastrointestinal disorders | Sildenafil | 2 | 7 | |
| other | Diarrhea | Gastrointestinal disorders | Sildenafil | 2 | 7 | |
| other | Flushing | Skin and subcutaneous tissue disorders | Sildenafil | 1 | 7 | |
| other | Epistaxis | Blood and lymphatic system disorders | Sildenafil | 1 | 7 | |
| other | Prolonged erections | Reproductive system and breast disorders | Sildenafil | 1 | 7 |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Sildenafil | ||
| Total, other adverse events | Sildenafil | 7 | 7 |
| Total, serious adverse events | Sildenafil | 0 | 7 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 24656411 | RESULT |
Source PubMed
Grants1
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.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years |
|---|---|---|---|---|---|
| UL1TR000093 | Stanford Center for Clinical and Translational Education and Research (SCCTER)UL1 | GREENBERG, HARRY BERNARD | STANFORD UNIVERSITY | NATIONAL CENTER FOR ADVANCING TRANSLATIONAL SCIENCES | 2012 to 2013 |
Source NIH RePORTER
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/NCT01290484
GET https://conductscience.org/api/trials/v1/NCT01290484/registered