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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00690937

Acronym

Sevelamer ECS

Enrollment

120

Registered

2008-06-05

Start date

2008-02-29

Completion date

2008-12-31

Last updated

2014-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypercholesterolemia

Keywords

hypercholesterolemia, bile acid sequestrant, LDL-cholesterol

Brief 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

Interventions

DRUGEnteric coated sevelamer

Drug treatment

DRUGColesevelam Cholestagel

Drug comparator

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
The primary safety endpoints are: The type and number of AEs and proportion of patients with AEs.	throughout study
Assessment of clinical laboratory parameters including blood chemistry, liver function tests, and renal function tests and hematology (CBC).	throughout study
The primary efficacy endpoint is: The percent change in LDL cholesterol from baseline.	From baseline to Day 42

Secondary

Measure	Time frame
The secondary efficacy endpoints are: the absolute change in LDL cholesterol from baseline.	From baseline to Day 42
The percent change in total cholesterol, HDL cholesterol and triglycerides from baseline.	From baseline to Day 42

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026