The 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…
ID
Source
Brief title
Health condition
pediatric hypertension
Sponsors and support
Intervention
Outcome measures
Primary outcome
pharmacokinetic parameters of the amlodipine liquid
Secondary outcome
bloodpressure control, using 24h ambulatory bloodpressure device
Background summary
Amlodipine 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
Study objective
The 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.
Study design
t=0; t=1 month
Intervention
treatment of pediatric patients with a newly developed amlodipine liquid for 1 month.
Gravendijkwal 230
L.M. Hanff
Rotterdam 3015 CE
The Netherlands
+31 (0)10 7037051
l.hanff@erasmusmc.nl
Gravendijkwal 230
L.M. Hanff
Rotterdam 3015 CE
The Netherlands
+31 (0)10 7037051
l.hanff@erasmusmc.nl
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
Design
Recruitment
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL4505 |
| NTR-old | NTR4623 |
| CCMO | NL47653.078.14 |
| OMON | NL-OMON41645 |