Calendario›SNY›Hectorol®
Hectorol®
A Phase 4, Conversion Study of Hectorol® Injection to Hectorol® Capsules in Stage 5 CKD Patients on Dialysis
Ensayo de Sanofi en Secondary Hyperparathyroidism (del registro, en inglés).
- Fase
- Fase 4
- Estado
- Completado
- Participantes
- 36
- Centros
- 8
- Fin del objetivo primario
- jun 2007
previstos
fecha real
Qué significa cada fase y cada estado.
Estudio de intervención, aleatorizado, abierto. Comenzó en nov 2006.
Qué mide
Dose Conversion (del registro, en inglés) (5 semanas)
Cómo lo describe el promotor
En el documentoEn inglés, del registroHectorol is a safe and effective treatment of secondary hyperparathyroidism in hemodialysis patients. Hectorol (doxercalciferol capsules) is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis and in pre-dialysis patients with Stage 3 or Stage 4 chronic kidney disease. Hectorol (doxercalciferol injection) is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis. This protocol will determine clinically appropriate doses of Hectorol (doxercalciferol capsules) when converting subject from Hectorol (doxercalciferol injection.) The study will enroll hemodialysis patients that have been controlled on intravenous Hectorol. the information gained from this study will be a useful guide for physicians in managing CKD Stage 5 patients for whom a change from intravenous to oral vitamin D administration is appropriate.
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Todos los de SNY, en su ficha.
Ficha completa en ClinicalTrials.gov (NCT00418600), actualizada en mar 2015.