[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100621587":3},{"organization":4,"armGroups":7,"interventions":8,"overallOfficials":12,"centralContacts":20,"locations":30,"responsibleParty":49,"collaborators":7,"id":51,"slug":52,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":7,"studyType":65,"phases":7,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":72,"whyStopped":7,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":82},{"fullName":5,"class":6},"University Hospital, Rouen","OTHER",null,[9],{"type":6,"name":10,"description":11,"armGroupLabels":7,"otherNames":7},"Evaluation of the pharmacokinetic parameters of an oral formulation of nicardipine hydrochloride","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\u002FF), the apparent clearance (Cl\u002FF), the maximum concentration (Cmax), the time to reach this concentration (Tmax), the elimination constant (ke), the elimination half-life (t1\u002F2), the apparent intercompartmental clearance (Q\u002FF), the apparent central volume (Vc\u002FF), and the apparent peripheral volume (Vp\u002FF).\n\nThis 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.",[13,17],{"name":14,"affiliation":15,"role":16},"Marine MC CAVELIER, Doctor","University Rouen Hospital","STUDY_DIRECTOR",{"name":18,"affiliation":15,"role":19},"Thomas TD DUFLOT, Doctor","STUDY_CHAIR",[21,27],{"name":22,"role":23,"phone":24,"phoneExt":25,"email":26},"Delphine DP PICOCHE, Director","CONTACT","02 32 88 82 65","+33","delphine.picoche@chu-rouen.fr",{"name":28,"role":23,"phone":24,"phoneExt":25,"email":29},"Vincent VF FERRANTI, ARC","vincent.ferranti@chu-rouen.fr",[31],{"facility":15,"status":7,"city":32,"state":7,"zip":33,"country":34,"countryCode":35,"cosmosGeoPoint":36,"geoPoint":41,"contacts":42},"Rouen","76031","France","FR",{"type":37,"coordinates":38},"Point",[39,40],1.09932,49.44313,{"lat":40,"lon":39},[43,46],{"name":14,"role":23,"phone":44,"phoneExt":25,"email":45},"02 32 88 19 26","marine.cavelier@chu-rouen.fr",{"name":18,"role":23,"phone":47,"phoneExt":25,"email":48},"02 32 88 56 34","thomas.duflot@chu-rouen.fr",{"type":50,"investigatorFullName":7,"investigatorTitle":7,"investigatorAffiliation":7,"oldNameTitle":7,"oldOrganization":7},"SPONSOR","100621587","pharmacometric-modeling-of-a-hospital-preparation-100621587",false,"NCT07372560","Pharmacometric Modeling of a Hospital Preparation","Pharmacometric Modeling of a Hospital Preparation of Nicardipine Hydrochloride Oral Solution at 2 mg\u002FmL in Hypertensive Patients in Pediatric Hematology-oncology","PEDIATENS","Inclusion Criteria:\n\n* Patients aged 1 to 15 years, male or female.\n* Patients followed in pediatric hematology-oncology.\n* Patients with a central venous catheter as part of their initial care and available for blood sampling.\n* Patients with a prescription for oral nicardipine (oral solution) whose formulation and\u002For dosage is\u002Fare not compatible with the commercial form of Loxen® 20 mg, requiring preparation.\n* Patients requiring oral administration of nicardipine every 8 hours (initial prescription or renewal).\n* Patients covered by a social security scheme.\n* Parents\u002Fguardians informed of the study and not objecting to their child's participation\n* For minors old enough to understand: patients who have not objected to the research.\n\nExclusion Criteria:\n\n* Patient n'ayant pas un schéma d'administration toutes les 8 heures.\n* Hypersensibilité à la substance active.\n* Antécédent d'allergie à l'un des excipients (polysorbate 80, hypromellose, saccharine sodique, sorbate de potassium, acide citrique, citrate de sodium, saccharose).\n* Refus de participation de l'enfant, des parents ou du représentant légal.\n* Inclusion de l'enfant dans un autre essai clinique, si des prélèvements sanguins supplémentaires sont également prévus, dans un délai de 7 jours.","ALL","1 Year","15 Years",{"count":63,"type":64},30,"ESTIMATED","OBSERVATIONAL","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\u002Fpharmacodynamic 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.",[68],"Hypertensive Patients",[70,71],"Pharmacometric modeling","hématologie-oncologie pédiatrique","NOT_YET_RECRUITING","2026-01-19",{"date":75,"type":76},"2026-01-28","ACTUAL",{"date":78,"type":64},"2026-03-01",{"date":80,"type":64},"2028-06-01",{"name":5,"class":6},1]