Pharmacokinetic and pharmacodynamic properties of amlodipine oral solution in the pediatric population - PK-PD of amlodipine in children

Erasmus MC0 个研究点开始时间: 2014年5月26日最近更新: 2016年1月25日

适应症

试验速览

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•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, a normal BP defined as mean SBP and DBP that is less than the 90th percentile for sex, age and height (1), no anticipated change in use of amlodipine or other antihypertensive medication, and use of the CYP3A4 inhibitor telaprevir and other antihypertensive agents should be at a fixed dosage for at least 2 weeks prior to the study. Renal transplant patients should have had their transplantation at least 4 months prior to recruitment.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 20
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•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).

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