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

NCT ID: NCT06860399

Last Updated: 2025-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 55 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2024-09-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Vardenfil

Oral Vardenafil given q12h.

Group Type: EXPERIMENTAL

Vardenafil

Intervention Type: DRUG

Oral Vardenafil

Sildenafil

Oral Sildenafil given q6h.

Group Type: ACTIVE_COMPARATOR

Sildenafil

Intervention Type: DRUG

Oral Sildenafil

Interventions

Vardenafil

Oral Vardenafil

Intervention Type: DRUG

Sildenafil

Oral Sildenafil

Intervention Type: DRUG

Other Intervention Names

fast fix; viagra

Eligibility Criteria

Inclusion Criteria

• Gestation age: 28 weeks or more

Exclusion Criteria

• Cardiac deformity, inability to administer the drug orally

• Minimum Eligible Age: 24 Hours
• Maximum Eligible Age: 96 Hours
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Damascus University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

prof. Srour

Role: STUDY_CHAIR

Children's Hospital Damascus

Locations

Children's Hospital

Damascus, , Syria

Countries

Syria

Other Identifiers

20230501

Identifier Type: OTHER

Identifier Source: secondary_id

UDMS-Pediatrics-2025-01

Identifier Type: -

Identifier Source: org_study_id