Trial | NCT00690937  Report issue

Title

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

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    colesevelam sevelamer ...

  • Study Participants

    120
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 Started
Feb 29
2008
Primary Completion
Dec 31
2008
Study Completion
Dec 31
2008
Last Update
Mar 19
2014
Estimate

Drug Enteric coated sevelamer

Drug treatment

  • Other names: ECS

Drug Enteric coated sevelamer

Drug treatment

Drug Colesevelam Cholestagel

Drug comparator

Drug Placebo

Placebo

Drug Placebo

Placebo

1 ECS Experimental

Low dose treatment

2 ECS Experimental

High dose treatment

3 Colesevelam Active Comparator

Active control treatment

4 Placebo Placebo Comparator

Placebo matched to low dose treatment

5 Placebo Placebo Comparator

Placebo matched to high dose treatment

Criteria 

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
No Results Posted