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

NCT06860399 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2025-03-06

No results posted yet for this 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

Conditions

  • PPHN

Interventions

DRUG

Vardenafil

Oral Vardenafil

DRUG

Sildenafil

Oral Sildenafil

Sponsors & Collaborators

  • Damascus University

    lead OTHER

Principal Investigators

  • prof. Srour · Children's Hospital Damascus

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
24 Hours
Max Age
96 Hours
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2024-09-30
Completion
2024-09-30

Countries

  • Syria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06860399 on ClinicalTrials.gov