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

Genzyme

Status and phase: Completed; Phase 2

Conditions: Hypercholesterolemia

Treatments: Drug: Placebo; Drug: Colesevelam Cholestagel; Drug: Enteric coated sevelamer

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT00690937

ELLS

ECS00107

Details and patient eligibility

About

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.

Full 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

Enrollment: 120 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 5 patient groups, including a placebo group

1 ECS

Experimental group

Description:

Low dose treatment

Treatment:

Drug: Enteric coated sevelamer

Drug: Enteric coated sevelamer

2 ECS

Experimental group

Description:

High dose treatment

Treatment:

Drug: Enteric coated sevelamer

Drug: Enteric coated sevelamer

3 Colesevelam

Active Comparator group

Description:

Active control treatment

Treatment:

Drug: Colesevelam Cholestagel

4 Placebo

Placebo Comparator group

Description:

Placebo matched to low dose treatment

Treatment:

Drug: Placebo

Drug: Placebo

5 Placebo

Placebo Comparator group

Description:

Placebo matched to high dose treatment

Treatment:

Drug: Placebo

Drug: Placebo