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Study on the use of amlodipine liquid in children


- candidate number18018
- NTR NumberNTR4623
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR2-jun-2014
- Secondary IDs2014-259 METC Erasmus MC Rotterdam
- Public TitleStudy on the use of amlodipine liquid in children
- Scientific TitlePharmacokinetic and pharmacodynamic characteristics of amlodipine oral liquid in the pediatric population
- ACRONYMamloliquid
- hypothesisThe primary objective of this study is to characterize the pharmacokinetic properties of amlodipine using the newly developed amlodipine oral solution 0.5 mg/ml in patients treated with amlodipine as antihypertensive drug aged 1 month to 12 years using a population pharmacokinetic study design. The secondary objective is to study the efficacy, safety and patient acceptability of the investigational product.
- Healt Condition(s) or Problem(s) studiedPediatric hypertension
- Inclusion criteria- age between 1 month and 12 years
- signed consent from the parent or legal assent
- expected ongoing treatment with amlodipine at the same dosage for at least 4 weeks
- Stable dosage of amlodipine
- Other antihypertensive medication is permitted but dosage should be stable
- CYP3A4 affecting co-medication1 is permitted but dosage should be stable.
- Exclusion criteria- concomitant treatment with another investigational drug within 1 month prior to study entry
- transient, unstable, malignant, or accelerated hypertension
- history of noncompliance
- 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 transplantation less than 4 months after their transplantation
- patients with nephrotic syndrome
- mec approval receivedno
- multicenter trialyes
- randomisedno
- groupCrossover
- TypeSingle arm
- Studytypeintervention
- planned startdate 1-sep-2014
- planned closingdate1-sep-2016
- Target number of participants20
- Interventionstreatment of pediatric patients with a newly developed amlodipine liquid for 1 month.
- Primary outcomepharmacokinetic parameters of the amlodipine liquid
- Secondary outcomebloodpressure control, using 24h ambulatory bloodpressure device
- Timepointst=0; t=1 month
- Trial web site
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. L.M. Hanff
- CONTACT for SCIENTIFIC QUERIESDr. L.M. Hanff
- Sponsor/Initiator Erasmus Medical Center
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryAmlodipine is commercially available as fixed-dosage tablets which do not comply with pediatric requirements of dose flexibility and ease of administration. Therefore an oral liquid for amlodipine was pharmaceutically developed and validated. In this study, pharmacokinetic characteristics, efficacy and acceptance of the new formulation is assessed in the target pediatric population
- Main changes (audit trail)
- RECORD2-jun-2014 - 1-jul-2014


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