A Phase 1/2 interventional study of Vardenafil and Sildenafil in PPHN, sponsored by Damascus University. Completed at 1 site in Syrian Arab Republic. Open to participants aged 24 Hours to 96 Hours. Per ClinicalTrials.gov, last updated 2025-03-06.
Sponsored by Damascus University · Phase 1/2, Interventional, and Treatment
The goal of this clinical trial is to learn if drug Vardenafil works to treat pulmonary hypertension in newborns, It will also learn about the safety of Vardenafil. The main questions it aims to answer are:
Does Vardenafil lower the pulmonary hypertension in newborns? What medical problems do participants have when taking Vardenafil? Researchers will compare drug Vardenafil to drug Sildenafil to see if drug Vardenafil works better to treat pulmonary hypertension.
Participants will be divided into 2 groups , one group will take oral drug: Vardenafil and the other group will take oral drug: Sildenafil every day.
Pulmonary hypertension will be measured daily until it returns to normal. Keep a diary of the symptoms and any complications
A double blind controlled trial in Children's Hospital Damascus between 5/2023 and 9/2024 on newborns up to 4 d old diagnosed with PPHN, patients were allocated randomly into one of the 2 arms of the study, group Sildenafil and group Vardenafil, both medicines administered orally, management of the patients was the same in both groups except for the investigated drug, pulmonary hypertension and resistance were measured by echo at diagnosis time and every 24 hours later on till normalization of pulmonary pressure, at the end of recruitment data was collected and analyzed to confirm the safety of Vardenafil and compare the efficacy of Vardenafil to Sildenafil
1,105 studies on the registry are indexed under Hypertension, Pulmonary; 234 are open to participants now.
This study's enrollment of 55 is above the median of 35 across 649 interventional studies indexed under Hypertension, Pulmonary.
Browse Hypertension, Pulmonary studies →Damascus University is the lead sponsor of 206 studies on the registry; 10 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Oral Vardenafil given q12h.
Drug: Vardenafil
Oral Sildenafil given q6h.
Drug: Sildenafil
Oral Vardenafil
Also known as: fast fix
Oral Sildenafil
Also known as: viagra
Pulmonary Hypertension
Pulmonary artery pressure is estimated from the tricuspid regurgitation velocity time measurement using echo doppler.
Time frame: Pulmonary hypertension is evaluated for each participant at time of diagnosis before taking the drug = day 0, then every 24 hours until obtaining normal measurement (up to day 4)
Pulmonary Resistance
Echo measurement using pulmonary artery acceleration time to right ventricle ejection time ratio
Time frame: Pulmonary resistance is evaluated for each participant at time of diagnosis before taking the drug = day 0, then every 24 hours until obtaining normal measurement (up to day 4)
Respiratory Distress
Respiratory rate and retractions evaluated by physical examination
Time frame: Each participant is examined every 6 hours from time of diagnosis before taking the drug = day 0 until pulmonary pressure normalization (up to day 4)
Death
Time frame: From day 1 of treatment till discharge from NICU ( 3 days to 90 days)
Plan to share: Yes — all IPD that underlie results in a publication
Supporting information: Study protocol, Sap, Csr
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Damascus University