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 with chronic kidney diseases (CKD) and/or hypertension aged 6 months to
ID
Source
Brief title
Condition
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary aim of this study is to characterize the pharmacokinetic parameters
clearance, volume of distribution, and absorption rate constant of amlodipine.
Secondary outcome
•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. .
Background summary
Amlodipine is commercially available as fixed-dosage tablets which do often not
meet pediatric requirements like dose flexibility and ease of administration.
Therefore, we developed a well-validated oral solution for amlodipine. Because
of the extensive use of amlodipine among pediatric patients, additional
information is necessary to adequately define the safety, efficacy and
pharmacokinetic properties of the new formulation in children.
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 with chronic kidney diseases (CKD) and/or hypertension aged 6
months 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
The study will be conducted as an one-sequence, open-label, multi-dose study
design
Intervention
All children will receive amlodipine oral solution 0.5 mg/ml in the same dosage
as their current amlodipine treatment.
Study burden and risks
During this study, 3 blood samples will be drawn during the steady-state phase
of the IMP using different sampling windows. Blood sampling will be combined as
much as possible with standard health care. Also blood pressure will be
measured once during the steady-state phase, using an oscillometric or 24-hour
ambulatory blood pressure monitoring device, depending on the ability and
willingness of the child. Because the IMP is administered with therapeutic
intent to a study population which is already used to amlodipine, the possible
risks of the IMP are expected to be negligible. Despite the burden of the study
procedures on the study population, all procedures are outweighed against the
future benefits of the IMP for the pediatric population, including
well-established safety, efficacy, pharmacokinetic properties and patient
acceptability.
Dr. Molewaterplein 60
Rotterdam 3015 CE
NL
Dr. Molewaterplein 60
Rotterdam 3015 CE
NL
Listed location countries
Age
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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2013-005323-17-NL |
| CCMO | NL47653.078.14 |
| Other | NTR 47653 |
| OMON | NL-OMON24405 |