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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-12-31

Brief Summary

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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.

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Detailed Description

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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

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Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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1 ECS

Low dose treatment

Group Type EXPERIMENTAL

Enteric coated sevelamer

Intervention Type DRUG

Drug treatment

2 ECS

High dose treatment

Group Type EXPERIMENTAL

Enteric coated sevelamer

Intervention Type DRUG

Drug treatment

3 Colesevelam

Active control treatment

Group Type ACTIVE_COMPARATOR

Colesevelam Cholestagel

Intervention Type DRUG

Drug comparator

4 Placebo

Placebo matched to low dose treatment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

5 Placebo

Placebo matched to high dose treatment

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo

Interventions

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Enteric coated sevelamer

Drug treatment

Intervention Type DRUG

Enteric coated sevelamer

Drug treatment

Intervention Type DRUG

Colesevelam Cholestagel

Drug comparator

Intervention Type DRUG

Placebo

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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ECS

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No