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

Phase 2

Completed

• Conditions: Hypercholesterolemia
• Interventions: Drug: Enteric coated sevelamer; Drug: Colesevelam Cholestagel; Drug: Placebo

• Registration Number: NCT00690937
• Lead Sponsor: Genzyme, a Sanofi Company

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

Study Timeline

• Study Start: 2008-02
• Study First Submitted: 2008-06-03
• Study First Submitted QC: 2008-06-04
• Study First Posted: 2008-06-05
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-17
• Last Update Posted: 2014-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2 ECS	Enteric coated sevelamer	High dose treatment
3 Colesevelam	Colesevelam Cholestagel	Active control treatment
4 Placebo	Placebo	Placebo matched to low dose treatment
5 Placebo	Placebo	Placebo matched to high dose treatment
1 ECS	Enteric coated sevelamer	Low dose treatment

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (8)

Appollo first Med Hospital; 🇮🇳 Chennai, India

Associates in Clinical Endocronolgy Education & Research (ACEER); 🇮🇳 Chennai, India

P D Hinduja National Hospital and Medical Research Centre; 🇮🇳 Mumbai, India

Indraprastha Apollo Hospitals; 🇮🇳 New Delhi, India

M S Ramaiah Medical College and Memorial Hospital; 🇮🇳 Bangalore, India

Diacon Hospital and Research Center; 🇮🇳 Bangalore, India

Diabetes Endocrine Nutrition Management and Research Center; 🇮🇳 Mumbai, India

Care Hospital; 🇮🇳 Hyderabad, India