Neonates and Preterm InfantsPhase 2NCT02244528
PK Study of Sildenafil in Neonate
A Phase 2 study testing Sildenafil in people with Neonates and Preterm Infants, run by Seoul National University Hospital at 2 sites in South Korea.
Trial summary
The purpose of this study is to investigate the pharmacokinetics of sildenafil which is used as treatment of pulmonary hypertension in neonate and preterm infant. Read more about this study
- Who is it for?
- Ages Up to 1 month
- Conditions the study is for
- Neonates and Preterm Infants
- What is being tested?
- Sildenafil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesSouth Korea
- Study dates
- Oct 2014to Oct 2016
- Phase
- Phase 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 Up to 1 month
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Admitted at NICU in Seoul National University Hospital or Bundang Seoul National University hospital
- Infants who were diagnosed with PAH
Who cannot join
- Severe allergic reaction to sildenafil
- Inotropics for hypotension within 3 days prior to enrollment
- AST or ALT > 3x ULN
- Any condition that would make the participant, in the opinion of the investigator, unsuitable for the stud
Trial locations and contacts
2 sites in 1 country.
South Korea2 sites
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, 463-707
Seoul National University Children's Hospital
Seoul, 110-744
About this study
Official title: Pharmacokinetic Study of Sildenafil in Neonates and Preterm Infants
The purpose of this study is to investigate the pharmacokinetics of sildenafil which is used as treatment of pulmonary hypertension in neonate and preterm infant.
- Conditions
- Neonates and Preterm Infants
- Being tested
- Sildenafil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SildenafilDrug
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | sildenafil treatment Receives: Drug: Sildenafil |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUC(0-t)
5 times drug level after 5 doses (pre30min/post 30min, 1hr, 2hr, 4hr) pharmacokinetics
Measured: t up to 5 weeks
Cmax(0-t)
5 times drug level after 5 doses (pre30min/post 30min, 1hr, 2hr, 4hr) pharmacokinetics
Measured: t up to 5 weeks
Secondary outcomes (2)
Change from baseline in pulmonary arterial hypertension at 5 weeks
Echocardiography
- RV systolic pressure: TR velocity2 x 4
- Septum contour: normal, flat at end-systole, flat at end-diastole
- LV shape: normal, partially D-shape, D-shape, squeezed
- LV eccentricity index
- RV area/LV area (Apical 4 chamber view, at end diastole)
- RA enlargement (Apical 4 chamber view)
- RV anterior wall thickness
- TAPSE (Tricuspid annular plane systolic excursion)
- RV Tei index (by tissue Doppler)
- Tissue Doppler velocity at RV free wall
Measured: pre, 2 weeks, 5 weeks of drug administration
respiratory severity score
Mean airway pressure x FiO2
Measured: pre, 2 weeks, 5 weeks after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neonates and Preterm InfantsStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Responsible party
- Principal investigator, Han-Suk Kim, Seoul National University Hospital
- Investigators
- Han-Suk Kim, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02244528
- Sponsor's protocol ID
- 14172MFDS178-1
- Status last verified
- Oct 2017
- First submitted
- 11 Sep 2014
- Last updated
- 16 Oct 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic Study of Sildenafil in Neonates and Preterm Infants
- ClinicalTrials.gov ID
- NCT02244528
- Acronym / sponsor ID
- 14172MFDS178-1
- Conditions
- Neonates and Preterm Infants
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- Seoul National University Bundang Hospital
- Study start
- Oct 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 19 Sep 2014 (estimated)
- 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 purpose of this study is to investigate the pharmacokinetics of sildenafil which is used as treatment of pulmonary hypertension in neonate and preterm infant.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Drug: Sildenafilsildenafil treatment |
Who may qualify
- Ages
- Up to 1 month
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Admitted at NICU in Seoul National University Hospital or Bundang Seoul National University hospital
- Infants who were diagnosed with PAH
Key exclusion criteria (4 listed)
- Severe allergic reaction to sildenafil
- Inotropics for hypotension within 3 days prior to enrollment
- AST or ALT > 3x ULN
- Any condition that would make the participant, in the opinion of the investigator, unsuitable for the stud
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 |
|---|---|---|
| Sildenafil | Drug | Treatment |
Primary outcome
AUC(0-t)
Time frame: t up to 5 weeks
5 times drug level after 5 doses (pre30min/post 30min, 1hr, 2hr, 4hr) pharmacokinetics
Cmax(0-t)
Time frame: t up to 5 weeks
5 times drug level after 5 doses (pre30min/post 30min, 1hr, 2hr, 4hr) pharmacokinetics
2 secondary outcomes
Change from baseline in pulmonary arterial hypertension at 5 weeks
Time frame: pre, 2 weeks, 5 weeks of drug administration
respiratory severity score
Time frame: pre, 2 weeks, 5 weeks after administration
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 16 Oct 2017.
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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.
Han-Suk Kim, MD, PhD principal investigator
Seoul National University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sildenafil in people with Neonates and Preterm Infants, run by Seoul National University Hospital at 2 sites in South Korea.
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 2 inclusion and 4 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 16 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in South Korea. 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 phase mean?
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?
AUC(0-t) (time frame: t up to 5 weeks). 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 16 Oct 2017.