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

Genzyme, a Sanofi Company120 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

120

Conditions

Hypercholesterolemia

Interventions

Enteric coated sevelamerDRUG

Drug treatment

Enteric coated sevelamerDRUG

Drug treatment

Colesevelam CholestagelDRUG

Drug comparator

Placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Males and females 18 years of age or older * Clinical diagnosis of mild to moderate hypercholesterolemia 1)LDL cholesterol greater than or equal to 130 mg/dL and less than or equal to 220 mg/dL 2) Triglycerides less than or equal to 300 mg/dL Exclusion Criteria: * Women who are pregnant or lactating. * Patients using other lipid-lowering medications during . * Patients with unstable medical conditions and/or comorbidities

Locations (8)

Diacon Hospital and Research Center

Bangalore, India

M S Ramaiah Medical College and Memorial Hospital

Bangalore, India

Appollo first Med Hospital

Chennai, India

Associates in Clinical Endocronolgy Education & Research (ACEER)

Chennai, India

Outcomes

Primary Outcomes

The primary safety endpoints are: The type and number of AEs and proportion of patients with AEs.

Time frame: throughout study

Assessment of clinical laboratory parameters including blood chemistry, liver function tests, and renal function tests and hematology (CBC).

Time frame: throughout study

The primary efficacy endpoint is: The percent change in LDL cholesterol from baseline.

Time frame: From baseline to Day 42

Secondary Outcomes

The secondary efficacy endpoints are: the absolute change in LDL cholesterol from baseline.

Time frame: From baseline to Day 42

The percent change in total cholesterol, HDL cholesterol and triglycerides from baseline.

Time frame: From baseline to Day 42

Data from ClinicalTrials.gov

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