Dose Titration of Lisinopril in Children Aged 1 to 18 Years With Primary or Secondary Hypertension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-25

Study Completion Date

2018-09-17

Brief Summary

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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.

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Detailed Description

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Conditions

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Primary Hypertension Secondary Hypertension

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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lisinopril

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

Group Type EXPERIMENTAL

lisinopril, ACE-inhibitor

Intervention Type DRUG

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

Interventions

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lisinopril, ACE-inhibitor

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No