NCT07372560Not yet recruiting
Pharmacometric Modeling of a Hospital Preparation
Pharmacometric Modeling of a Hospital Preparation of Nicardipine Hydrochloride Oral Solution at 2 mg/mL in Hypertensive Patients in Pediatric Hematology-oncology
Source: ClinicalTrials.gov · Last updated 28 Jan 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 30 (estimated)
- First submitted
- 19 Jan 2026
- Start date
- 1 Mar 2026
- Primary completion date
- 1 Dec 2027
- Lead sponsor
- University Hospital, Rouen
- Diseases
- Childhood cancers
- NCT number
- NCT07372560
What you commit to
- Study type: Observational
- Planned participants: 30
- From 1 Mar 2026 to the primary completion date, 1 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- Antécédent d'allergie à l'un des excipients (polysorbate 80, hypromellose, saccharine sodique, sorbate de potassium, acide citrique, citrate de sodium, saccharose).
Other
- Patient n'ayant pas un schéma d'administration toutes les 8 heures.
- Hypersensibilité à la substance active.
- 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.
Who the study is looking for
- 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.
Age in the registry: 1 year to 15 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Rouen Hospital Coordinator of this site? Confirm its status | Rouen | France | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.