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
Bron
Verkorte titel
Aandoening
pediatric hypertension
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
pharmacokinetic parameters of the amlodipine liquid
Achtergrond van het onderzoek
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
Doel van het onderzoek
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.
Onderzoeksopzet
t=0; t=1 month
Onderzoeksproduct en/of interventie
treatment of pediatric patients with a newly developed amlodipine liquid for 1 month.
Publiek
Gravendijkwal 230
L.M. Hanff
Rotterdam 3015 CE
The Netherlands
+31 (0)10 7037051
l.hanff@erasmusmc.nl
Wetenschappelijk
Gravendijkwal 230
L.M. Hanff
Rotterdam 3015 CE
The Netherlands
+31 (0)10 7037051
l.hanff@erasmusmc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- 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.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
- 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
Opzet
Deelname
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In overige registers
| Register | ID |
|---|---|
| NTR-new | NL4505 |
| NTR-old | NTR4623 |
| CCMO | NL47653.078.14 |
| OMON | NL-OMON41645 |