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
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
More Related Trials
-
IV Sildenafil Persistent Pulmonary Hypertension Of The Newborn
NCT01360671 ·Status: WITHDRAWN ·Phase: PHASE2
-
Population Pharmacokinetics and Dosage Individualization of Oral Pulmonary Vasodilators in PPHN
NCT04379180 ·Status: UNKNOWN
-
Efficacy of Type-5 Phosphodiesterase Inhibitors in Primary and Secondary Pulmonary Hypertension
NCT00155714 ·Status: WITHDRAWN ·Phase: NA
-
Efficacy and Safety of Milrinone Versus Sildenafil in the Treatment of Neonates With Persistent Pulmonary Hypertension
NCT04391478 ·Status: COMPLETED ·Phase: PHASE1
-
A Non-Interventional Follow Up Study For Subjects Who Received Sildenafil for Persistent Pulmonary Hypertension of the Newborn (PPHN)
NCT01801982 ·Status: COMPLETED
-
Sildenafil in Hemodialysis Patients With Pulmonary Hypertension
NCT03763045 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3
-
PK Study of Sildenafil in Neonate
NCT02244528 ·Status: COMPLETED ·Phase: PHASE2
-
Oral Sildenafil in Persistent Pulmonary Hypertension Secondary to Meconium Aspiration Syndrome in Newborns
NCT01757782 ·Status: COMPLETED ·Phase: PHASE4
-
Sildenofil in Persistent Pulmonary Hypertension in Newborns
NCT01558466 ·Status: UNKNOWN ·Phase: PHASE3
-
L-arginine Versus Sildenafil in Children With Beta Thalassemia Associated With Pulmonary Hypertension
NCT03402191 ·Status: UNKNOWN ·Phase: PHASE4
-
Improving Right Ventricular Function in Young Adults Born Preterm
NCT03696758 ·Status: COMPLETED ·Phase: PHASE2
-
Sildenafil Therapy for Pulmonary Hypertension and Sickle Cell Disease
NCT00492531 ·Status: TERMINATED ·Phase: PHASE2
-
A Randomized, Double-Blind, Placebo-Controlled Study of Sildenafil in Children With Pulmonary Arterial Hypertension.
NCT00159913 ·Status: COMPLETED ·Phase: PHASE3
-
Effect of Sildenafil Citrate on Uteri- Placental Perfusion, Doppler Indices in Growth Restricted Fetuses
NCT02362399 ·Status: COMPLETED ·Phase: NA
-
Effect of Regular Sildenafil on Blood Pressure and Arterial Function in Hypertension
NCT00317421 ·Status: COMPLETED ·Phase: PHASE2
-
A Long Term Extension Study Evaluating Safety Of Sildenafil Citrate When Used To Treat Pulmonary Arterial Hypertension (PAH) In Children
NCT00159874 ·Status: COMPLETED ·Phase: PHASE3
-
Efficacy of Phosphodiesterase-type 5 Inhibitors in Patients With Univentricular Congenital Heart Disease
NCT03997097 ·Status: WITHDRAWN ·Phase: PHASE3
-
Nitro Oxide Inhalation Continued With Sildenafil on Neonatal Persistent Pulmonary Hypertension
NCT01373749 ·Status: UNKNOWN ·Phase: NA
-
Sildenafil and Uteroplacental Perfusion
NCT01107782 ·Status: UNKNOWN ·Phase: PHASE2/PHASE3
-
Sildenafil in Single Ventricle Patients
NCT01169519 ·Status: COMPLETED ·Phase: PHASE1
-
Sildenafil Citrate Therapy for Oligohydramnios
NCT02372487 ·Status: UNKNOWN ·Phase: NA
-
Evaluation of Sildenafil for the Treatment of Moderate Congestive Heart Failure
NCT00793338 ·Status: WITHDRAWN ·Phase: PHASE4
-
Effectiveness of the Vasodilator Test With Revatio, Made in Patients With Acute Pulmonary Hypertension
NCT01091012 ·Status: UNKNOWN ·Phase: PHASE3
-
Endothelin Blockade in Patients With Single Ventricle Physiology
NCT00989911 ·Status: COMPLETED ·Phase: NA
-
Reversibility by Sildenafil of Exercise-Induced Abnormal Right Ventricular Pressure Response in ASD and VSD-Operated Patients
NCT00772135 ·Status: UNKNOWN ·Phase: NA