high blood pressure Hypertension
Conditions
Interventions
All children will receive amlodipine oral solution 0.5 mg/ml in the same dosage
as their current amlodipine treatment.
Sponsors
Erasmus MC, Universitair Medisch Centrum Rotterdam
Eligibility
Age
2 Years to 11 Years
Inclusion criteria
Inclusion criteria: Age between 6 months and 12 years, signed consent from the parent or legal assent, ongoing treatment with amlodipine at the same dosage for at least 2 weeks, no anticipated change in use of amlodipine or other antihypertensive medication
Exclusion criteria
Exclusion criteria: Concomitant treatment with another investigational drug within 1 month prior to study entry, transient, unstable, malignant, or accelerated hypertension, poor vascular access, history of noncompliance, allergy to one of the compounds of the investigational product, or one of the contraindications of amlodipine use (hypersensitivity to dihydropyridine derivatives, severe hypotension, shock (including cardiogenic shock), obstruction of the outflow tract of the left ventricle (e.g. aortic stenosis), hemodynamically unstable heart failure after acute myocardial infarction), renal transplant within 4 months before inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary aim of this study is to characterize the pharmacokinetic parameters clearance, volume of distribution, and absorption rate constant of amlodipine. | — |
Secondary
| Measure | Time frame |
|---|---|
| •The safety of amlodipine oral solution 0.5 mg/ml. •The effect of the once and twice daily dosing regimen of amlodipine on the mean SBP and DBP and amlodipine plasma concentrations. •The taste of amlodipine oral solution 0.5 mg/ml using VAS. •The preference of formulation of children and their parents using a questionnaire including ease of administration and patient acceptance. . | — |
Countries
Netherlands
Outcome results
None listed