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

Last updated: March 3, 2025
Sponsor: Damascus University
Overall Status: Completed

Phase

1/2

Condition

Vascular Diseases

Circulation Disorders

Stress

Treatment

Sildenafil

Vardenafil

Clinical Study ID

NCT06860399
UDMS-Pediatrics-2025-01
20230501
  • Ages 24-96
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Gestation age: 28 weeks or more

Exclusion

Exclusion Criteria:

  • Cardiac deformity, inability to administer the drug orally

Study Design

Total Participants: 55
Treatment Group(s): 2
Primary Treatment: Sildenafil
Phase: 1/2
Study Start date:
May 01, 2023
Estimated Completion Date:
September 30, 2024

Study 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

Connect with a study center

  • Children's Hospital

    Damascus, 011
    Syrian Arab Republic

    Site Not Available

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