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Sevelamer hydrochloride

Study to Compare Once A Day Sevelamer Dosing With Three Times Per Day Sevelamer Dosing

Ensayo de Sanofi en Enfermedad renal cronica.

Más ensayos de: Enfermedad renal crónica.

Fase

Fase 2

Estado

Completado

Participantes

24

previstos

Centros

2

Qué significa cada fase y cada estado.

Estudio de intervención, aleatorizado, abierto. Comenzó en mar 2003.

Qué mide

Treatment compared on basis of serum phosphorus at end of each treatment and calcium corrected for albumin,calcium-phosphorus product,albumin,iPTH,total,LDL,HDL,non-HDL cholesterol,triglycerides. Safety evaluated on AEs;change in lab values. (del registro, en inglés)

Cómo lo describe el promotor

En el documentoEn inglés, del registroA randomized, cross-over, open-label study will be conducted to evaluate the equivalency, safety and tolerability of sevelamer once per day dosing, given with the largest meal, compared with standard three times per day dosing, in hemodialysis patients previously using sevelamer. Following a two week Run-In period, a total of 24 patients will be randomized to one of the following treatment sequences: 1. sevelamer dosed once a day with the largest meal followed by standard three times per day dosing with meals 2. sevelamer dosed three times per day with meals followed by once a day dosing with the largest meal. Patients will maintain a fixed daily dose throughout both treatment periods based on the most recently prescribed sevelamer dose prior to screening.

Más ensayos de SNY

Todos los de SNY, en su ficha.

Ficha completa en ClinicalTrials.gov (NCT00324376), actualizada en mar 2015.