NL-OMON41645
Completed
Not Applicable
Pharmacokinetic and pharmacodynamic properties of amlodipine oral liquid in the pediatric population - PK-PD of amlodipine in children
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- high blood pressure
- Sponsor
- Erasmus MC, Universitair Medisch Centrum Rotterdam
- Enrollment
- 20
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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