Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07372560
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
1 Year
Maximum Age:
15 Years
Study:
NCT07372560
Study Brief:
Protocol Section:
NCT07372560