Dose Titration of Lisinopril in Children Aged 1 to 18 Years With Primary or Secondary Hypertension (Lisi-ped)

University Ghent

Status and phase: Completed; Phase 4

Conditions: Secondary Hypertension; Primary Hypertension

Treatments: Drug: lisinopril, ACE-inhibitor

Study type: Interventional

Funder types: Other

Identifiers

NCT02184858

EC project number: 2012/498

2012-002927-14 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 13 patients

Sex: All

Ages: 1 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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
• 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 design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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13 participants in 1 patient group

lisinopril

Experimental group

Description:

dose titration of investigational product (lisinopril) dependant on blood pressure, levels of renin and aldosterone and on adverse events.

Treatment:

Drug: lisinopril, ACE-inhibitor