PPHNPhase 1/2PPHNNCT06860399
Vardenafil Vs Sildenafil for the Treatment of Pulmonary Hypertension of the Newborn
A Phase 1/2 study testing Vardenafil and Sildenafil in people with PPHN, run by Damascus University at 1 site in Syria.
Trial 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… Read more about this study
- Who is it for?
- Ages 24 to 96 hours
- Conditions the study is for
- PPHN
- What is being tested?
- Vardenafil and Sildenafil
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteSyria
- Study dates
- 1 May 2023to 30 Sep 2024
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 24 to 96 hours
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Gestation age: 28 weeks or more
Who cannot join
- Cardiac deformity, inability to administer the drug orally
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effectiveness of Vardenafil Vs Sildenafil for The Treatment of Pulmonary Hypertension of the Newborn
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.
Read more
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
Read the 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
- Being tested
- Vardenafil, Sildenafil
- Keywords
- PPHN, Sildenafil, Vardenafil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VardenafilDrug
Also called fast fix
Oral Vardenafil
SildenafilDrug
Also called viagra
Oral Sildenafil
| Study group | Role | What they receive |
|---|---|---|
| Vardenfil | Experimental | Oral Vardenafil given q12h. Receives: Drug: Vardenafil |
| Sildenafil | Active comparator | Oral Sildenafil given q6h. Receives: Drug: Sildenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulmonary Hypertension
Pulmonary artery pressure is estimated from the tricuspid regurgitation velocity time measurement using echo doppler.
Measured: Pulmonary hypertension is evaluated for each participant at time of diagnosis before taking the drug = day 0, then every 24 hours until obtaining normal measurement (up to day 4)
Pulmonary Resistance
Echo measurement using pulmonary artery acceleration time to right ventricle ejection time ratio
Measured: Pulmonary resistance is evaluated for each participant at time of diagnosis before taking the drug = day 0, then every 24 hours until obtaining normal measurement (up to day 4)
Secondary outcomes (2)
Respiratory Distress
Respiratory rate and retractions evaluated by physical examination
Measured: Each participant is examined every 6 hours from time of diagnosis before taking the drug = day 0 until pulmonary pressure normalization (up to day 4)
Death
Measured: From day 1 of treatment till discharge from NICU ( 3 days to 90 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2025
- Study start1 May 2023
- Primary completion30 Sep 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PPHNStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- prof. Srour, Study chair, Children's Hospital Damascus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06860399
- Sponsor's protocol ID
- UDMS-Pediatrics-2025-01
- Other IDs
- 20230501
- Acronym
- PPHN
- Status last verified
- Mar 2025
- First submitted
- 19 Feb 2025
- Last updated
- 6 Mar 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Vardenafil Vs Sildenafil for The Treatment of Pulmonary Hypertension of the Newborn
- ClinicalTrials.gov ID
- NCT06860399
- Acronym / sponsor ID
- PPHN / UDMS-Pediatrics-2025-01
- Conditions
- PPHN
- Keywords
- PPHN, Sildenafil, Vardenafil
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 6 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vardenfil | Experimental | Drug: VardenafilOral Vardenafil given q12h. |
| Sildenafil | Active comparator | Drug: SildenafilOral Sildenafil given q6h. |
Who may qualify
- Ages
- 24 to 96 hours
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Gestation age: 28 weeks or more
Key exclusion criteria (1 listed)
- Cardiac deformity, inability to administer the drug orally
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VardenafilAlso: fast fixOral Vardenafil | Drug | Vardenfil |
| SildenafilAlso: viagraOral Sildenafil | Drug | Sildenafil |
Primary outcome
Pulmonary Hypertension
Time frame: Pulmonary hypertension is evaluated for each participant at time of diagnosis before taking the drug = day 0, then every 24 hours until obtaining normal measurement (up to day 4)
Pulmonary artery pressure is estimated from the tricuspid regurgitation velocity time measurement using echo doppler.
Pulmonary Resistance
Time frame: Pulmonary resistance is evaluated for each participant at time of diagnosis before taking the drug = day 0, then every 24 hours until obtaining normal measurement (up to day 4)
Echo measurement using pulmonary artery acceleration time to right ventricle ejection time ratio
2 secondary outcomes
Respiratory Distress
Time frame: Each participant is examined every 6 hours from time of diagnosis before taking the drug = day 0 until pulmonary pressure normalization (up to day 4)
Death
Time frame: From day 1 of treatment till discharge from NICU ( 3 days to 90 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2025.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
Related trials for PPHN
Active, not recruitingPhase 2
Effect of a Parenteral Emulsion With Omega3 on Neonates With PPHN and CDH
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Recruiting
Effect of Melatonin on Pulmonary Hypertension in Full Term Neonates
Congenital Peumonia, Persistent Pulmonary Hypertension of Newborn
Not yet recruitingObservational study
Post Market Clinical Follow-up to Assess the Portable Nitric Oxide Generation and Delivery System (INOwill N200) for the Treatment of Neonatal Hypoxic Respiratory Failure Complicated by Pulmonary Hypertension
Persistent Pulmonary Hypertension of the Newborn, Hypoxic Respiratory Failure
Not yet recruitingObservational study
Predictors of Outcomes in Pulmonary Hypertension of the Newborn
Hypertension, Pulmonary, Infant, Newborn, Diseases
RecruitingPhase 4
Dopamine vs. Norepinephrine for Hypotension in Neonates With Pulmonary Hypertension (DONE)
Hypotension and Shock, Pulmonary Hypertension of the Newborn (PPHN)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
prof. Srour study chair
Children's Hospital Damascus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Vardenafil and Sildenafil in people with PPHN, run by Damascus University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Hypertension (time frame: Pulmonary hypertension is evaluated for each participant at time of diagnosis before taking the drug = day 0, then every 24 hours until obtaining normal measurement (up to day 4)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2025.