Pharmacokinetic and pharmacodynamic properties of amlodipine oral liquid in the pediatric populatio
- Conditions
- high blood pressureHypertension10057166
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary aim of this study is to characterize the pharmacokinetic parameters<br /><br>clearance, volume of distribution, and absorption rate constant of amlodipine.</p><br>
- Secondary Outcome Measures
Name Time Method <p>•The safety of amlodipine oral solution 0.5 mg/ml.<br /><br>•The effect of the once and twice daily dosing regimen of amlodipine on the<br /><br>mean SBP and DBP and amlodipine plasma concentrations.<br /><br>•The taste of amlodipine oral solution 0.5 mg/ml using VAS.<br /><br>•The preference of formulation of children and their parents using a<br /><br>questionnaire including ease of administration and patient acceptance. .</p><br>