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Sildenafil 20 mg tablets for Lymphatic Diseases

Phase 2
Waitlist Available
Led By Joyce Teng
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 20
Awards & highlights

Study Summary

This trial is testing whether sildenafil is safe and effective for children with lymphatic malformations. Subjects will be given either the drug or a placebo, and the study will track changes in lesion volume and other safety and efficacy measures.

Eligible Conditions
  • Lymphatic Diseases
  • Lymphatic Malformations

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 20
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, week 20 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Pharmaceutical Preparations
Secondary outcome measures
Change in Subject's Assessment of Change in Lymphatic Malformation Overall Score

Side effects data

From 2021 Phase 2 trial • 22 Patients • NCT02335242
33%
Headaches
33%
Cold
33%
Cough
33%
Rhinorrhea
17%
Cellulitis
17%
Abdominal pain/bloating
17%
Nausea/vomit
17%
Loose stool/increase bowel movement
17%
Intermittent flushing
17%
Ear pain
100%
80%
60%
40%
20%
0%
Study treatment Arm
Double-Blind Placebo
Open-Label Sildenafil
Double-Blind Sildenafil

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Sildenafil 20 mg tablets (Revatio)Experimental Treatment1 Intervention
Active Drug: Sildenafil tablets (Revatio)
Group II: Placebo tablets (resembling Revatio)Placebo Group1 Intervention
Placebo Drug: Placebo tablets (resembling Revatio)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Sildenafil 20 mg tablets
2015
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

Stanford UniversityLead Sponsor
2,395 Previous Clinical Trials
17,341,573 Total Patients Enrolled
1 Trials studying Lymphatic Diseases
5,000 Patients Enrolled for Lymphatic Diseases
Ann & Robert H Lurie Children's Hospital of ChicagoOTHER
258 Previous Clinical Trials
5,189,108 Total Patients Enrolled
Joyce TengPrincipal Investigator - Stanford School of Medicine
Lucile Packard Children's Hospital Stanford
Vanderbilt University School Of Medicine (Medical School)
Vanderbilt University Medical Center (Residency)
1 Previous Clinical Trials
50 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
Journal of Pediatric SurgeryJournal
Sclerotherapy for Lymphatic Malformations in Children: A Scoping Review
Churchill, Paige, Damanjot Otal, Julia Pemberton, Abdullah Ali, Helene Flageole, and J. Mark Walton. 2011. “Sclerotherapy for Lymphatic Malformations in Children: A Scoping Review”. Journal of Pediatric Surgery. Elsevier BV. doi:10.1016/j.jpedsurg.2011.02.027.
Journal of the American Academy of DermatologyJournal
Diagnosis and Management of Extensive Vascular Malformations of the Lower Limb
Redondo, Pedro, Leyre Aguado, and Antonio Martínez-Cuesta. 2011. “Diagnosis and Management of Extensive Vascular Malformations of the Lower Limb”. Journal of the American Academy of Dermatology. Elsevier BV. doi:10.1016/j.jaad.2010.12.047.
GeneJournal
Identification and Characterization of a New Human Type 9 Cgmp-specific Phosphodiesterase Splice Variant (PDE9A5)
Wang, Peng, Ping Wu, Robert W. Egan, and M.Motasim Billah. 2003. “Identification and Characterization of a New Human Type 9 Cgmp-specific Phosphodiesterase Splice Variant (PDE9A5)”. Gene. Elsevier BV. doi:10.1016/s0378-1119(03)00733-9.
congenital Lymphatic MalformationsJournal
<i>congenital Lymphatic Malformations</i>
Blei, Francine. 2008. “congenital Lymphatic Malformations”. Annals of the New York Academy of Sciences. Wiley. doi:10.1196/annals.1413.016.
~2 spots leftby Apr 2025
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