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Cross-Over Study of Sevelamer Hydrochloride and Sevelamer Carbonate

NCT00440648 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2014-03-19

No results posted yet for this study

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

Conditions

Interventions

DRUG

sevelamer carbonate, sevelamer hydrochloride

Starting dose individualized for each patient and fixed daily dose throughout both treatment periods

DRUG

sevelamer hydrochloride, sevelamer carbonate

Starting dose individualized for each patient and fixed daily dose throughout both treatment periods

Sponsors & Collaborators

  • Genzyme, a Sanofi Company

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Genzyme, a Sanofi Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2006-03-31
Completion
2006-07-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00440648 on ClinicalTrials.gov