Hypertensive PatientsPEDIATENSNCT07372560
Pharmacometric Modeling of a Hospital Preparation
An observational study of Hypertensive Patients, run by University Hospital, Rouen at 1 site in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 1 year to 15 years
- Conditions the study is for
- Hypertensive Patients
- What is being tested?
- Evaluation of the pharmacokinetic parameters of an oral formulation of nicardipine hydrochloride
- Type of treatment
- Pill or oral medicine
- How many people
- 30 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2026to 1 Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 15 years
- All sexes
- No healthy volunteers
- Child
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)
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
University Rouen Hospital
Rouen, 76031
Marine MC CAVELIER, Doctor, 02 32 88 19 26 ext. +33, marine.cavelier@chu-rouen.fr
Thomas TD DUFLOT, Doctor, 02 32 88 56 34 ext. +33, thomas.duflot@chu-rouen.fr
About this study
Official title: 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.
Read the 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.
- Conditions
- Hypertensive Patients
- Being tested
- Evaluation of the pharmacokinetic parameters of an oral formulation of nicardipine hydrochloride
- Keywords
- Pharmacometric modeling, hématologie-oncologie pédiatrique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of the pharmacokinetic parameters of an oral formulation of nicardipine hydrochlorideOther
These pharmacokinetic parameters aim to optimize the use of this preparation in the management of pediatric hypertension. The pharmacokinetic parameters are: the area under the curve (AUC), the apparent volume of distribution (Vd/F), the apparent clearance (Cl/F), the maximum concentration (Cmax), the time to reach this concentration (Tmax), the elimination constant (ke), the elimination half-life (t1/2), the apparent intercompartmental clearance (Q/F), the apparent central volume (Vc/F), and the apparent peripheral volume (Vp/F).
This kinetic profile will be obtained using Monolix® software modeling with the results of validated blood sampling methods. A small blood volume (1 mL) is required for these samples, which are taken from children who previously had a central venous catheter inserted.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)).
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.
Measured: 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)).
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.
Measured: 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)).
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.
Measured: 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)).
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.
Measured: 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)).
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.
Measured: 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)).
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.
Measured: 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)).
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.
Measured: 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)).
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.
Measured: 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)).
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.
Measured: 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)).
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.
Measured: 24 hours
Secondary outcomes (9)
Describe the distribution of the residual concentration at 24 hours
Evaluate the determination of the residual concentration of nicardipine hydrochloride at 24 hours.
Measured: 24 hours
Demographic parameters of the studied population: sex
Evaluate the demographic parameters of the studied population: sex
Measured: 24 hours
Demographic parameters of the studied population: age
Evaluate the demographic parameters of the studied population: age
Measured: 24 hours
Demographic parameters of the studied population: weight .
Evaluate the demographic parameters of the studied population: weight.
Measured: 24 hours
Demographic parameters of the studied population: height.
Evaluate the demographic parameters of the studied population : height.
Measured: 24 hours
Dosages of the studied population: dose/kg/8 hours.
Collection and measurement of prescribed nicardipine dosages: dose/kg/8 hours
Measured: 24 hours
A mathematical model capable of predicting, through simulation, exposure to and the antihypertensive effects of nicardipine in this population.
Measurement of blood pressure (systolic and diastolic) and heart rate using a monitor to propose a mathematical model of pharmacodynamic parameters
Measured: 24 hours
Tolerance to treatment
Collection of adverse events reported to the Regional Pharmacovigilance Centre (CRPV) in the context of routine practice
Measured: 24 hours
Acceptability of treatment
The acceptability of the oral solution (in the form of a visual analog scale) will be assessed at each of the 3 doses
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2026
- Study start1 Mar 2026 (estimated)
- Primary completion1 Dec 2027 (estimated)
- Study completion1 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertensive PatientsStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marine MC CAVELIER, Doctor, Study director, University Rouen HospitalThomas TD DUFLOT, Doctor, Study chair, University Rouen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07372560
- Sponsor's protocol ID
- 2022/0354/OB
- Other IDs
- N° IDRCB : 2025-A01969-40
- Acronym
- PEDIATENS
- Status last verified
- Nov 2025
- First submitted
- 19 Jan 2026
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data provided will be the property of the sponsor and will be used solely for its own research activities.
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacometric Modeling of a Hospital Preparation of Nicardipine Hydrochloride Oral Solution at 2 mg/mL in Hypertensive Patients in Pediatric Hematology-oncology
- ClinicalTrials.gov ID
- NCT07372560
- Acronym / sponsor ID
- PEDIATENS / 2022/0354/OB
- Conditions
- Hypertensive Patients
- Keywords
- Pharmacometric modeling, hématologie-oncologie pédiatrique
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 1 Dec 2027 (estimated)
- Study completion
- 1 Jun 2028 (estimated)
- First posted
- 28 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 year to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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)
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Evaluation of the pharmacokinetic parameters of an oral formulation of nicardipine hydrochlorideThese pharmacokinetic parameters aim to optimize the use of this preparation in the management of pediatric hypertension. The pharmacokinetic parameters are: the area under the curve (AUC), the apparent volume of distribution (Vd/F), the apparent clearance (Cl/F), the maximum concentration (Cmax), the time to reach this concentration (Tmax), the elimination constant (ke), the elimination half-life (t1/2), the apparent intercompartmental clearance (Q/F), the apparent central volume (Vc/F), and the apparent peripheral volume (Vp/F). This kinetic profile will be obtained using Monolix® software modeling with the results of validated blood sampling methods. A small blood volume (1 mL) is required for these samples, which are taken from children who previously had a central venous catheter inserted. | Other | – |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
9 secondary outcomes
Describe the distribution of the residual concentration at 24 hours
Time frame: 24 hours
Demographic parameters of the studied population: sex
Time frame: 24 hours
Demographic parameters of the studied population: age
Time frame: 24 hours
Demographic parameters of the studied population: weight .
Time frame: 24 hours
Demographic parameters of the studied population: height.
Time frame: 24 hours
Dosages of the studied population: dose/kg/8 hours.
Time frame: 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
Tolerance to treatment
Time frame: 24 hours
Acceptability of treatment
Time frame: 24 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
- Individual participant dataSharing planned: No. The data provided will be the property of the sponsor and will be used solely for its own research activities.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Marine MC CAVELIER, Doctor study director
University Rouen Hospital
Thomas TD DUFLOT, Doctor study chair
University Rouen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertensive Patients, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Delphine DP PICOCHE, Director (02 32 88 82 65 ext. +33, delphine.picoche@chu-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026.