NCT06860399

Vardenafil Vs Sildenafil for the Treatment of Pulmonary Hypertension of the Newborn

The Effectiveness of Vardenafil Vs Sildenafil for The Treatment of Pulmonary Hypertension of the Newborn

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Damascus University · Academic / Other
• Sex: All
• Age: 24 Hours – 96 Hours
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• PPHN

Interventions

Type	Name	Description
DRUG	Vardenafil	Oral Vardenafil
DRUG	Sildenafil	Oral Sildenafil

Timeline

• Start date: 2023-05-01
• Primary completion: 2024-09-30
• Completion: 2024-09-30
• First posted: 2025-03-06
• Last updated: 2025-03-06

Locations

1 site across 1 country: Syria