drugset / Trial / NCT00440648

Cross-Over Study of Sevelamer Hydrochloride and Sevelamer Carbonate

NCT00440648

Phase 2 Completed 80 enrolled Genzyme, a Sanofi Company
RandomizedCrossoverQuadruple-blindTreatment

Summary

This is a double-blind, randomized, cross-over study conducted at centers within the United States. The study consists of five periods: an up to two-week Screening Period, a 5-week Run-In Period, two eight-week study treatment periods and a two-week Washout Period. Patients are assigned randomly (1:1) to one of two treatment sequences: sevelamer carbonate for eight weeks followed by sevelamer hydrochloride for eight weeks or sevelamer hydrochloride for eight weeks followed by sevelamer carbonate for eight weeks

Timeline

Start
2005-03
Primary completion
2006-03
Completion
2006-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Sevelamer Other / unclassified