drugset / Trial / NCT00441545

Head to Head Study Against Sevelamer Hydrochloride

NCT00441545 ↗

Phase 3 Completed 182 enrolled Shire
RandomizedCrossoverOpen-labelTreatment

Summary

To compare the efficacy of Fosrenol (Lanthanum carbonate) and sevelamer hydrochloride in the reduction of serum phosphorus levels from baseline.

Timeline

Start
2007-01-05
Primary completion
2008-07-31
Completion
2008-07-31

Outcome

Missed primary endpoint

registry analysis (unspecified test); Fosrenol vs Sevelamer HCl; p = 0.1130; ANCOVA NCT00441545 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Lanthanum Carbonate Other / unclassified 3000 mg Oral
Comparator Sevelamer Other / unclassified 6400 mg Oral