Pharmacometric Modeling of a Hospital Preparation (PEDIATENS)

January 19, 2026 updated by: University Hospital, Rouen

Pharmacometric Modeling of a Hospital Preparation of Nicardipine Hydrochloride Oral Solution at 2 mg/mL in Hypertensive Patients in Pediatric Hematology-oncology

Pediatric prescribers are very often faced with a lack of suitable therapies, particularly oral ones. This represents a major public health problem and necessitates adjustments to dosage or pharmaceutical form using medications marketed for adults, some of which contain excipients that may be harmful to children. This creates risks of dilution errors, administration errors, and the occurrence of adverse effects. Hospital pharmacy technicians are called upon daily to provide appropriate treatment for children. However, although this activity is authorized (Public Health Code, Good Preparation Practices), pharmacokinetic/pharmacodynamic studies on these preparations are only exceptionally carried out. Indeed, only stability studies are required to determine the expiration date of the preparation. Thus, prescribers are left without the necessary information to choose the dosage and administration schedule. Pediatric dosages are extrapolated from those for adults without any certainty of the treatment's effectiveness.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The pediatric hematology-oncology department wanted to include an oral form of nicardipine in its therapeutic arsenal. Nicardipine is a widely used antihypertensive drug for secondary hypertension, particularly that caused by corticosteroid use. This oral form is preferred for its flexibility in dosing, which is based on weight and blood pressure readings. A first formulation was developed in 2017 and subsequently optimized in terms of excipients and raw material availability, leading to a second formulation in 2021. Nicardipine oral solution has been routinely prepared, dispensed, and administered for many years. The lack of bibliographic data concerning the use of nicardipine in a pediatric population prevents us from understanding the pharmacokinetic (PK) parameters, which are nevertheless essential for optimizing the benefit/risk balance of the drug and for individualizing doses. This study aims to optimize the use of this preparation in the management of hypertension in pediatrics and to promote the benefits of this formulation. This study is valuable because it is situated within the context of the routine therapeutic management of a patient in the pediatric hematology-oncology department suffering from hypertension. It therefore does not entail any modification of the child's care.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Children in pediatric hematology-oncology requiring nicardipine administration as part of their standard care whether or not they are nicardipine-naïve (switching from the intravenous form used for hypertensive emergencies to the oral form, or patients already receiving hospital-prepared nicardipine oral solution at 2 mg/mL)

Description

Inclusion Criteria:

  • Patients aged 1 to 15 years, male or female.
  • Patients followed in pediatric hematology-oncology.
  • Patients with a central venous catheter as part of their initial care and available for blood sampling.
  • Patients with a prescription for oral nicardipine (oral solution) whose formulation and/or dosage is/are not compatible with the commercial form of Loxen® 20 mg, requiring preparation.
  • Patients requiring oral administration of nicardipine every 8 hours (initial prescription or renewal).
  • Patients covered by a social security scheme.
  • Parents/guardians informed of the study and not objecting to their child's participation
  • For minors old enough to understand: patients who have not objected to the research.

Exclusion Criteria:

  • Patient n'ayant pas un schéma d'administration toutes les 8 heures.
  • Hypersensibilité à la substance active.
  • Antécédent d'allergie à l'un des excipients (polysorbate 80, hypromellose, saccharine sodique, sorbate de potassium, acide citrique, citrate de sodium, saccharose).
  • Refus de participation de l'enfant, des parents ou du représentant légal.
  • Inclusion de l'enfant dans un autre essai clinique, si des prélèvements sanguins supplémentaires sont également prévus, dans un délai de 7 jours.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pharmacokinetic parameters in the target population of an oral formulation of nicardipine hydrochloride prepared by the pharmaceutical technology unit of the pharmacy at the Rouen University Hospital (Area Under the Curve (AUC)).
Time Frame: 24 hours
This kinetic profile will be obtained through modeling using Monolix® software and the results of validated assays of the samples. A small blood volume (1 mL) is required for these samples, which are taken from children who previously had a central venous catheter inserted.
24 hours
Pharmacokinetic parameters in the target population of an oral formulation of nicardipine hydrochloride prepared by the pharmaceutical technology unit of the pharmacy at the Rouen University Hospital (apparent distribution volume (Vd/F)).
Time Frame: 24 hours
This kinetic profile will be obtained through modeling using Monolix® software and the results of validated assays of the samples. A small blood volume (1 mL) is required for these samples, which are taken from children who previously had a central venous catheter inserted.
24 hours
Pharmacokinetic parameters in the target population of an oral formulation of nicardipine hydrochloride prepared by the pharmaceutical technology unit of the pharmacy at the Rouen University Hospital (apparent clearance (Cl/F)).
Time Frame: 24 hours
This kinetic profile will be obtained through modeling using Monolix® software and the results of validated assays of the samples. A small blood volume (1 mL) is required for these samples, which are taken from children who previously had a central venous catheter inserted.
24 hours
Pharmacokinetic parameters in the target population of an oral formulation of nicardipine hydrochloride prepared by the pharmaceutical technology unit of the pharmacy at the Rouen University Hospital (maximum concentration (Cmax)).
Time Frame: 24 hours
This kinetic profile will be obtained through modeling using Monolix® software and the results of validated assays of the samples. A small blood volume (1 mL) is required for these samples, which are taken from children who previously had a central venous catheter inserted.
24 hours
Pharmacokinetic parameters in the target population of an oral formulation of nicardipine hydrochloride prepared by the pharmaceutical technology unit of the pharmacy at the Rouen University Hospital (time to reach this concentration (Tmax)).
Time Frame: 24 hours
This kinetic profile will be obtained through modeling using Monolix® software and the results of validated assays of the samples. A small blood volume (1 mL) is required for these samples, which are taken from children who previously had a central venous catheter inserted.
24 hours
Pharmacokinetic parameters in the target population of an oral formulation of nicardipine hydrochloride prepared by the pharmaceutical technology unit of the pharmacy at the Rouen University Hospital (elimination constant (ke)).
Time Frame: 24 hours
This kinetic profile will be obtained through modeling using Monolix® software and the results of validated assays of the samples. A small blood volume (1 mL) is required for these samples, which are taken from children who previously had a central venous catheter inserted.
24 hours
Pharmacokinetic parameters in the target population of an oral formulation of nicardipine hydrochloride prepared by the pharmaceutical technology unit of the pharmacy at the Rouen University Hospital (elimination half-life (t1/2)).
Time Frame: 24 hours
This kinetic profile will be obtained through modeling using Monolix® software and the results of validated assays of the samples. A small blood volume (1 mL) is required for these samples, which are taken from children who previously had a central venous catheter inserted.
24 hours
Pharmacokinetic parameters in the target population of an oral formulation of nicardipine hydrochloride prepared by the pharmaceutical technology unit of the pharmacy at the Rouen University Hospital (clairance inter-compartimentale apparente (Q/F)).
Time Frame: 24 hours
This kinetic profile will be obtained through modeling using Monolix® software and the results of validated assays of the samples. A small blood volume (1 mL) is required for these samples, which are taken from children who previously had a central venous catheter inserted.
24 hours
Pharmacokinetic parameters in the target population of an oral formulation of nicardipine hydrochloride prepared by the pharmaceutical technology unit of the pharmacy at the Rouen University Hospital (apparent central volume (Vc/F)).
Time Frame: 24 hours
This kinetic profile will be obtained through modeling using Monolix® software and the results of validated assays of the samples. A small blood volume (1 mL) is required for these samples, which are taken from children who previously had a central venous catheter inserted.
24 hours
Pharmacokinetic parameters in the target population of an oral formulation of nicardipine hydrochloride prepared by the pharmaceutical technology unit of the pharmacy at the Rouen University Hospital (apparent peripheral volume (Vp/F)).
Time Frame: 24 hours
This kinetic profile will be obtained through modeling using Monolix® software and the results of validated assays of the samples. A small blood volume (1 mL) is required for these samples, which are taken from children who previously had a central venous catheter inserted.
24 hours

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Describe the distribution of the residual concentration at 24 hours
Time Frame: 24 hours
Evaluate the determination of the residual concentration of nicardipine hydrochloride at 24 hours.
24 hours
Demographic parameters of the studied population: sex
Time Frame: 24 hours
Evaluate the demographic parameters of the studied population: sex
24 hours
Demographic parameters of the studied population: age
Time Frame: 24 hours
Evaluate the demographic parameters of the studied population: age
24 hours
Demographic parameters of the studied population: weight .
Time Frame: 24 hours
Evaluate the demographic parameters of the studied population: weight.
24 hours
Demographic parameters of the studied population: height.
Time Frame: 24 hours
Evaluate the demographic parameters of the studied population : height.
24 hours
Dosages of the studied population: dose/kg/8 hours.
Time Frame: 24 hours
Collection and measurement of prescribed nicardipine dosages: dose/kg/8 hours
24 hours
A mathematical model capable of predicting, through simulation, exposure to and the antihypertensive effects of nicardipine in this population.
Time Frame: 24 hours
Measurement of blood pressure (systolic and diastolic) and heart rate using a monitor to propose a mathematical model of pharmacodynamic parameters
24 hours
Tolerance to treatment
Time Frame: 24 hours
Collection of adverse events reported to the Regional Pharmacovigilance Centre (CRPV) in the context of routine practice
24 hours
Acceptability of treatment
Time Frame: 24 hours
The acceptability of the oral solution (in the form of a visual analog scale) will be assessed at each of the 3 doses
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Rouen

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Marine MC CAVELIER, Doctor, University Rouen Hospital
  • Study Chair: Thomas TD DUFLOT, Doctor, University Rouen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 19, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 28, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 19, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2022/0354/OB
  • N° IDRCB : 2025-A01969-40 (Other Identifier: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The data provided will be the property of the sponsor and will be used solely for its own research activities.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings