Primary HypertensionPhase 4Lisi-pedNCT02184858
Dose Titration of Lisinopril in Children Aged 1 to 18 Years With Primary or Secondary Hypertension
A Phase 4 study testing lisinopril, ACE-inhibitor in people with Primary Hypertension and Secondary Hypertension, run by University Ghent at 1 site in Belgium.
Trial summary
This open label 4 month study will evaluate efficacy (blood pressure lowering effects) and safety of lisinopril in children 1-18y whose parents grant permission to participate. This dose titration study is being conducted to support the statement that personalized titration of lisinopril (based on blood pressure and… Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Primary Hypertension, Secondary Hypertension
- What is being tested?
- lisinopril, ACE-inhibitor
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteBelgium
- Study dates
- 25 Jun 2014to 17 Sep 2018
- Phase
- Phase 4
- 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 1 year to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Parental consent must be granted
- Patient age: 1y - 18 y
- Documented diagnosis of hypertension as defined in the National Heart, Lung and Blood Institute (NHBLI) 4th report, 2004
- No reversible cause found on diagnostic work-up for hypertension
- Children older than 6y: 24h blood pressure monitoring confirms the diagnosis of hypertension
Who cannot join
- Pregnancy
- Sexually active girls can only be included in the trial if they use an adequate form of birth control; during and until 30 days after ending the trial
- Following abnormal laboratory values: Hyperkaliemia (serum potassium > 5.3mmol/L); Anemia (hemoglobin < 8g/dL); AST or ALT > 3 times the upper limit of reference range; Total bilirubin > 3 times the upper limit of reference range
- Abnormalities of the oral cavity that can influence intake of medication
- Known sensitivity to ACE-inhibitors
- Known lactose intolerance
Show all 11Show fewer
- History of angioedema
- Unilateral or bilateral stenosis of the renal artery
- Diagnosis of heart failure (NYHA Class II-IV)
- History of coarctation of the aorta
- Current treatment with: other drugs influencing the renin-angiotensin-aldosterone system; lithium; potassium sparing diuretics; non-steroidal anti-inflammatory drugs; aspirin; oral antidiabetic medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dose Titration Study to Test Efficacy and Safety of Lisinopril in Children Aged 1 to 18 Years With Primary or Secondary Hypertension.
This open label 4 month study will evaluate efficacy (blood pressure lowering effects) and safety of lisinopril in children 1-18y whose parents grant permission to participate. This dose titration study is being conducted to support the statement that personalized titration of lisinopril (based on blood pressure and renin-aldosterone ratio) can increase patient response.
- Conditions
- Primary Hypertension, Secondary Hypertension
- Being tested
- lisinopril, ACE-inhibitor
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lisinopril, ACE-inhibitorDrug
Lisinopril 0.1mg/kg/d, titration with + 0.1mg/kg/d. Max; daily dose: 0.4mg/kg. CAVE: dose reduction in case of renal impairment
| Study group | Role | What they receive |
|---|---|---|
| lisinopril | Experimental | dose titration of investigational product (lisinopril) dependant on blood pressure, levels of renin and aldosterone and on adverse events. Receives: Drug: lisinopril, ACE-inhibitor |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure
Measured: 4 months
Secondary outcomes (2)
Serum concentrations will be assessed after every dose titration
Measured: trough and 4 hours post dosing
Adverse events with assessment of specific blood parameters
sodium, potassium, creatinine, bilirubin, aspartate transaminase/alanine transaminase (AST/ALT) and blood count
Measured: up to 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study start25 Jun 2014
- Primary completion8 May 2017
- Study completion17 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Primary HypertensionStudies of the same condition, open and under way.
- More trials run by University GhentThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johan Vande Walle, PhD MD, Principal investigator, Ghent University, Department of Pediatrics and Medical Genetics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02184858
- Sponsor's protocol ID
- EC project number: 2012/498
- Other IDs
- 2012-002927-14
- Acronym
- Lisi-ped
- Status last verified
- Sep 2018
- First submitted
- 10 Jun 2014
- Last updated
- 20 Sep 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sandra L, Degraeuwe E, De Bruyne P, De Baere S, Croubels S, Van Bocxlaer JFP, Raes A, Vande Walle J, Gasthuys E, Vermeulen A. Population pharmacokinetics of lisinopril in hypertensive children and adolescents with normal to mildly reduced kidney function. Br J Clin Pharmacol. 2024 Feb;90(2):504-515. doi: 10.1111/bcp.15936. Epub 2023 Nov 10.
PubMed 37864281
Study at a glance
From the registry record, last updated by the sponsor on 20 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose Titration Study to Test Efficacy and Safety of Lisinopril in Children Aged 1 to 18 Years With Primary or Secondary Hypertension.
- ClinicalTrials.gov ID
- NCT02184858
- Acronym / sponsor ID
- Lisi-ped / EC project number: 2012/498
- Conditions
- Primary Hypertension, Secondary Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Study start
- 25 Jun 2014 (actual)
- Primary completion
- 8 May 2017 (actual)
- Study completion
- 17 Sep 2018 (actual)
- First posted
- 9 Jul 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.
This open label 4 month study will evaluate efficacy (blood pressure lowering effects) and safety of lisinopril in children 1-18y whose parents grant permission to participate. This dose titration study is being conducted to support the statement that personalized titration of lisinopril (based on blood pressure and renin-aldosterone ratio) can increase patient response.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| lisinopril | Experimental | Drug: lisinopril, ACE-inhibitordose titration of investigational product (lisinopril) dependant on blood pressure, levels of renin and aldosterone and on adverse events. |
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Parental consent must be granted
- Patient age: 1y - 18 y
- Documented diagnosis of hypertension as defined in the National Heart, Lung and Blood Institute (NHBLI) 4th report, 2004
- No reversible cause found on diagnostic work-up for hypertension
- Children older than 6y: 24h blood pressure monitoring confirms the diagnosis of hypertension
Key exclusion criteria (11 listed)
- Pregnancy
- Sexually active girls can only be included in the trial if they use an adequate form of birth control; during and until 30 days after ending the trial
- Following abnormal laboratory values: Hyperkaliemia (serum potassium > 5.3mmol/L); Anemia (hemoglobin < 8g/dL); AST or ALT > 3 times the upper limit of reference range; Total bilirubin > 3 times the upper limit of reference range
- Abnormalities of the oral cavity that can influence intake of medication
- Known sensitivity to ACE-inhibitors
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 |
|---|---|---|
| lisinopril, ACE-inhibitorLisinopril 0.1mg/kg/d, titration with + 0.1mg/kg/d. Max; daily dose: 0.4mg/kg. CAVE: dose reduction in case of renal impairment | Drug | lisinopril |
Primary outcome
blood pressure
Time frame: 4 months
2 secondary outcomes
Serum concentrations will be assessed after every dose titration
Time frame: trough and 4 hours post dosing
Adverse events with assessment of specific blood parameters
Time frame: up to 4 months
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 20 Sep 2018.
- Derived from this study: PubMed 37864281Sandra L, Degraeuwe E, De Bruyne P, De Baere S, Croubels S, Van Bocxlaer JFP, Raes A, Vande Walle J, Gasthuys E, Vermeulen A. Population pharmacokinetics of lisinopril in hypertensive children and adolescents with normal to mildly reduced kidney function. Br J Clin Pharmacol. 2024 Feb;90(2):504-515. doi: 10.1111/bcp.15936. Epub 2023 Nov 10.
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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.
Johan Vande Walle, PhD MD principal investigator
Ghent University, Department of Pediatrics and Medical Genetics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing lisinopril, ACE-inhibitor in people with Primary Hypertension and Secondary Hypertension, run by University Ghent at 1 site in Belgium.
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 5 inclusion and 11 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 20 Sep 2018. 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 Belgium. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
blood pressure (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02184858, which also lists 1 linked publication.
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 20 Sep 2018.