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

Study Overview
=================
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

Official Title
-----------------
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

Conditions
-----------------
Hypercholesterolemia

Intervention / Treatment
-----------------
* Drug: Enteric coated sevelamer
* Drug: Enteric coated sevelamer
* Drug: Colesevelam Cholestagel
* Drug: Placebo
* Drug: Placebo


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 ECS<br>Low dose treatment | Drug: Enteric coated sevelamer<br>* Drug treatment<br>* Other names: ECS;|
| Experimental: 2 ECS<br>High dose treatment | Drug: Enteric coated sevelamer<br>* Drug treatment<br>|
| Active Comparator: 3 Colesevelam<br>Active control treatment | Drug: Colesevelam Cholestagel<br>* Drug comparator<br>|
| Placebo Comparator: 4 Placebo<br>Placebo matched to low dose treatment | Drug: Placebo<br>* Placebo<br>|
| Placebo Comparator: 5 Placebo<br>Placebo matched to high dose treatment | Drug: Placebo<br>* Placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hypercholesterolemia, bile acid sequestrant, LDL-cholesterol