Hypertension
Conditions
Interventions
Product Name: Amlodipine oral solution 0.5 mg/ml
Pharmaceutical Form: Oral solution
INN or Proposed INN: amlodipine
Other descriptive name: AMLODIPINE BESILATE
Concentration unit: mg/ml milligram(s)/m
Sponsors
Erasmus MC
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age between 6 months and =65 years) no F.1.3.1 Number of subjects for this age range
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to characterize the pharmacokinetic properties (clearance (Cl), volume of distribution (Vd), and absorption rate constant (ka)) of amlodipine using the newly developed amlodipine oral solution 0.5 mg/ml in patients with chronic kidney diseases (CKD) and hypertension aged 6 months to <12 years using a population pharmacokinetic study design. ;Secondary Objective: •To evaluate the safety of amlodipine oral solution 0.5 mg/ml. •To assess the effect of the once and twice daily dosing regimen of amlodipine on SBP and DBP and amlodipine plasma concentrations. •To assess the taste of amlodipine oral solution 0.5 mg/ml. •To assess the preference of amlodipine formulation of children and their parents. ;Primary end point(s): Pharmacokinetic parameters Cl, Vd, and ka of amlodipine using the newly developed amlodipine oral solution 0.5 mg/ml. ;Timepoint(s) of evaluation of this end point: All pharmacokinetic parameters will be evaluated after completion of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •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. . ;Timepoint(s) of evaluation of this end point: All secondary endpoints will be evaluated after completion of the study. | — |
Countries
Netherlands
Contacts
Public ContactErasmus MC-Sophia Hospital Pharmacy
Erasmus MC
Outcome results
None listed