NCT00690937

A Multicenter, Active and Placebo-controlled Study of Enteric Coated Sevelamer in Patients With Mild to Moderate Hypercholesteremia

A Multicenter, Single-blind, Active and Placebo-controlled, Parallel-group, Randomized Study of Two Dosing Regimens of Enteric Coated Sevelamer in Patients With Mild to Moderate Hypercholesterolemia

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (actual)
• Sponsor: Genzyme, a Sanofi Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A total of 120 patients will be entered in this study to assess the safety and efficacy of enteric coated sevelamer (ECS) to lower LDL cholesterol. Patients will be randomized into two active treatment groups, two placebo groups and one active control group.

Detailed description

This is a prospective, randomized, single blind, active and placebo-controlled, parallel-group, multi-center study. Two groups of ECS consisting of 3 and 6 tablets/day (n=30), two placebo groups of 3 and 6 tablets/day (n=15 each) and one active control group of colesevelam 6 tablets/day (n=30). The study is being conducted solely in India and there will be a total of 6-8 sites. The safety parameters are: * Serious adverse events SAEs * Treatment and non-treatment emergent AEs * Physical exams and vital signs * Clinical safety laboratories The efficacy parameters include a fasting lipid profile: * Low density lipoproteins (LDL) * Total cholesterol * High density lipoproteins (HDL) * Triglycerides

Conditions

• Hypercholesterolemia

Interventions

Type	Name	Description
DRUG	Enteric coated sevelamer	Drug treatment
DRUG	Enteric coated sevelamer	Drug treatment
DRUG	Colesevelam Cholestagel	Drug comparator
DRUG	Placebo	Placebo
DRUG	Placebo	Placebo

Timeline

• Start date: 2008-02-01
• Primary completion: 2008-12-01
• Completion: 2008-12-01
• First posted: 2008-06-05
• Last updated: 2014-03-19

Locations

8 sites across 1 country: India