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

Hypercholesterolemia Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hypercholesterolemia

• NCT number: NCT00690937
• Study type: Interventional
• Source: Sanofi
• Status: Completed
• Phase: Phase 2
• Start date: February 2008
• Completion date: December 2008